Topical corticosteroids for treating phimosis in boys

Gladys Moreno; Cristian Ramirez; Javiera Corbalán; Blanca Peñaloza; Macarena Morel Marambio; Tomas Pantoja

doi:10.1002/14651858.CD008973.pub3

. 2024 Jan 25;2024(1):CD008973. doi: 10.1002/14651858.CD008973.pub3

Topical corticosteroids for treating phimosis in boys

Gladys Moreno ^1,^✉, Cristian Ramirez ², Javiera Corbalán ³, Blanca Peñaloza ⁴, Macarena Morel Marambio ², Tomas Pantoja ⁴

Editor: Cochrane Urology Group

PMCID: PMC10809033 PMID: 38269441

Abstract

Background

This is an updated version of a Cochrane Review first published in 2014. Phimosis is a condition in which the prepuce (foreskin) cannot be fully retracted past the head of the penis (glans). Phimosis is often treated surgically by circumcision or prepuce plasty; however, reports of non‐invasive treatment using topical corticosteroids applied for four to eight weeks have suggested favorable outcomes.

Objectives

To assess the effects of topical corticosteroids applied to the stenotic portion of the prepuce for the treatment of phimosis in boys compared with placebo or no treatment.

Search methods

We searched CENTRAL, MEDLINE, Embase, LILACS, and ClinicalTrial.gov. We checked reference lists of included studies and relevant reviews for additional studies. There were no restrictions on the language of publication. The date of the last search was 4 October 2023.

Selection criteria

We included all randomized controlled trials (RCTs) that compared the use of any topical corticosteroid with placebo or no treatment for boys with any type or degree of phimosis.

Data collection and analysis

Two review authors independently selected studies, extracted data related to the review's primary and secondary outcomes, and assessed the studies' risk of bias. We used the random‐effects model for statistical analyses and expressed dichotomous outcomes as risk ratios (RRs) with 95% confidence intervals (CIs). We contacted the authors of the primary articles to request details of the study design and specific outcome data. We used GRADE to assess the certainty of evidence on a per‐outcome basis.

Main results

In this update, we identified two new studies with 111 participants, bringing the total number of included studies to 14 (1459 randomized participants). We found that types of corticosteroids investigated, participant age, degree of phimosis, type of phimosis, and treatment duration varied considerably among studies.

Compared with placebo or no treatment, topical corticosteroids may increase the complete resolution of phimosis after four to eight weeks of treatment (RR 2.73, 95% CI 1.79 to 4.16; I² = 72%; 10 trials, 834 participants; low‐certainty evidence). Based on 252 complete resolutions per 1000 boys in the control group, this corresponds to 436 more complete resolutions per 1000 boys (95% CI 199 more to 796 more). We downgraded the certainty of the evidence by one level for serious study limitations and by one level for serious inconsistency.

Topical corticosteroids may also increase the partial resolution of phimosis at four to eight weeks of treatment compared with placebo or no treatment (RR 1.68, 95% CI 1.17 to 2.40; I² = 44%; 7 trials, 745 participants; low‐certainty evidence). Based on 297 partial resolutions per 1000 boys in the control group, this corresponds to 202 more partial resolutions per 1000 boys (95% CI 50 more to 416 more). We downgraded the certainty of the evidence by one level for serious study limitations and by one level for serious inconsistency.

We are uncertain of the effect of topical corticosteroids compared to placebo on change in retractability score (standardized mean difference [SMD] −1.48, 95% CI −2.93 to −0.03; I²91%; 2 trials, 177 participants; very low‐certainty evidence). We downgraded the certainty of the evidence by one level for serious study limitations, one level for serious heterogeneity, and one level for serious imprecision.

Compared with placebo, topical corticosteroids may increase the long‐term complete resolution of phimosis six or more months after treatment (RR 4.09, 95% CI 2.80 to 5.97; I² = 0%; 2 trials, 280 participants; low‐certainty evidence). Based on 171 long‐term complete resolutions per 1000 boys in the control group, this corresponds to 528 more complete resolutions per 1000 boys (95% CI 308 more to 850 more). We downgraded the certainty of the evidence by one level for serious study limitations and by one level for serious imprecision.

There may be little or no difference in the risk of adverse effects between topical corticosteroids and placebo or no treatment (RR 0.28, 95% CI 0.03 to 2.62; I² = 22%; 11 trials, 1091 participants; low‐certainty evidence). Only two of 11 studies that recorded adverse effects reported any adverse effects; one event occurred in the corticosteroid group and six in the control group. We downgraded the certainty of the evidence by one level for serious study limitations and by one level for serious imprecision.

Authors' conclusions

Topical corticosteroids, compared to placebo or no treatment, may increase complete and partial resolution of phimosis when assessed after four to eight weeks of treatment, and may increase long‐term complete resolution of phimosis assessed six or more months after treatment. Topical corticosteroids may have few or no adverse effects, and we are uncertain about their effect on retractability scores. The body of evidence is limited by poor reporting of methods in the studies, important clinical heterogeneity, and serious imprecision in the results. Future, higher‐quality trials with long‐term follow‐up would likely improve our understanding of the effects of topical corticoids on phimosis in boys.

Keywords: Humans; Male; Adrenal Cortex Hormones; Adrenal Cortex Hormones/therapeutic use; Circumcision, Male; Dermatologic Agents; Drug-Related Side Effects and Adverse Reactions; Phimosis; Phimosis/drug therapy; Phimosis/surgery

Plain language summary

Topical corticosteroids for treating phimosis in boys

Review question

Are topical corticosteroids effective for the treatment of phimosis in boys?

What is phimosis?

Phimosis is a condition where the skin protecting the head of the penis (foreskin) cannot be fully drawn back (retracted). Phimosis is normal at birth and often self‐corrects without treatment. This is known as congenital or physiological phimosis. Phimosis can also be caused by scarring of the foreskin, a condition called pathological phimosis. It can be difficult to distinguish between the two types. One in ten three‐year‐old boys and one in 100 16‐year‐old boys have phimosis.

How is phimosis treated?

Operations to remove or widen the foreskin (circumcision and prepuce plasty) have been widely used to treat phimosis. However, creams and ointments containing corticosteroids (medicines that reduce inflammation and limit or stop immune system activity) have shown promising results. This offers a less invasive form of treatment and may limit the need for surgery among some boys.

What did we want to find out?

We wanted to find out if corticosteroid creams or ointments (topical corticosteroids) were better than dummy treatment (placebo) or no treatment for improving the following outcomes.

• Complete retraction of the foreskin • Partial retraction of the foreskin • Change in retractability score • Long‐term complete resolution of phimosis • Unwanted effects on the area treated or other parts of the body

What did we do?

We searched for studies that looked at topical corticosteroids compared with placebo or no treatment in boys (aged birth to 18 years) with phimosis. We only included randomized controlled trials, where boys were assigned to either corticosteroids or placebo/no treatment at random. We compared and summarized the results of the studies and rated our confidence in the evidence, based on factors such as study methods and sizes.

What did we find?

We found 14 randomized trials, including 1459 boys. The studies included boys of different ages (18 days to 17 years), with different types and degrees of phimosis. The studies used different types of corticosteroids, and treatment duration varied from four to eight weeks.

Main results

We found that topical corticosteroids compared to placebo or no treatment may increase the frequency of complete and partial retraction of the foreskin after four to eight weeks of treatment. Topical corticosteroids may also increase the probability of complete retraction of the foreskin measured six months after treatment. We are uncertain of the effect of corticosteroids on retractability of the foreskin compared to placebo. Only two studies reported unwanted effects at the site of treatment (out of 11 studies that measured unwanted effects). There may be little or no difference between corticosteroids and placebo or no treatment in the occurrence of unwanted effects.

What are the limitations of the evidence?

We have little or very little confidence in the evidence because most publications provided an inadequate description of the study methods; because there were important differences between the boys included in the studies (age, how severe the phimosis was) and between the treatments used (type of corticosteroids, duration of treatment); and because some of the results were very imprecise.

How up to date is this evidence?

This review updates our previous review (published in 2014). The evidence is up to date to October 2023.

Summary of findings

Summary of findings 1. Topical corticosteroids compared to placebo or no treatment for treating phimosis in boys.

Topical corticosteroids compared to placebo for treating phimosis in boys
Patient or population: boys up to 18 years old with phimosis Setting: outpatient pediatric surgery/urology clinics Intervention: topical corticosteroids Comparison: placebo or no treatment
Outcomes	№ of participants (studies)	Certainty of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects (95% CI)**		Interpretation
				Risk with placebo	Risk difference with topical corticosteroids
Complete resolution of phimosis Follow‐up: 4–8 weeks MCID: 50 per 1000	834 (10 RCTs)	⊕⊕⊝⊝ Low^a,b	RR 2.73 (1.79 to 4.16)	Study population		Topical corticosteroids may increase complete resolution of phimosis compared to placebo or no treatment.
				230 per 1000	436 more per 1000 (199 more to 796 more)
Partial resolution of phimosis Follow‐up: 4–8 weeks MCID: 50 per 1000	745 (7 RCTs)	⊕⊕⊝⊝ Low^a,b	RR 1.68 (1.17 to 2.40)	Study population		Topical corticosteroids may increase partial resolution of phimosis compared to placebo or no treatment.
				297 per 1000	202 more per 1000 (50 more to 416 more)
Change in retractability score Follow‐up: 4–8 weeks MCID: 0.3	177 (2 RCTs)	⊕⊝⊝⊝ Very low^a,b,c	SMD −1.48 (−2.93 to −0.03)	—		It is uncertain if topical corticosteroids affect retractability of the prepuce compared to placebo.
Long‐term complete resolution of phimosis Follow‐up: ≥ 6 months MCID: 50 per 1000	280 (2 RCTs)	⊕⊕⊝⊝ Low^a,c	RR 4.09 (2.80 to 5.97)	Study population		Topical corticosteroids may increase long‐term complete resolution of phimosis compared to placebo or no treatment.
				171 per 1000	529 more per 1000 (308 more to 850 more)
Adverse effects (any) Follow‐up: 1–12 months MCID: 50 per 1000	1091 (11 RCTs)	⊕⊕⊝⊝ Low^a,c	RR 0.28 (0.03 to 2.62)	Study population		There may be little or no difference in the risk of adverse effects between topical corticosteroids and placebo or no treatment.
				11 per 1000	8 fewer per 1000 (11 fewer to 18 more)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; MCID: minimum clinically important difference; RCT: randomized controlled trial; RR: risk ratio; SMD: standardized mean difference.
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect.

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^a Downgraded one level for study limitations due to unclear or high risk of bias for more than one domain in more than 50% of studies. ^b Downgraded one level for inconsistency due to substantial heterogeneity among studies. ^c Downgraded one level for imprecision due to wide confidence interval that crosses clinically meaningful thresholds.

Background

Description of the condition

Phimosis is defined as a tight distal preputial ring that makes manual retraction of the prepuce behind the balano‐preputial sulcus difficult or impossible. Phimosis creates major concerns for parents and is responsible for significant numbers of consultations, referrals to pediatric surgeons, and circumcisions (Huntley 2003; NICE‐accredited Commissioning Guide 2016; Rickwood 2000; Spilsbury 2003).

Phimosis in boys is a physiological condition frequently present at birth, but that often resolves during the first three to four years of life. An estimated 96% of all newborns have phimosis, but this estimate falls to 50% by one year of age, 10% by three years, 6% to 8% by seven years, and 1% by 16 years (Gairdner 1949; Oster 1968; Morris 2020). These data indicate that in most cases, the natural history of physiological phimosis tends towards spontaneous resolution, and only a small proportion of boys will continue into adulthood with the condition.

The diagnosis of physiological phimosis is based on the presence of phimosis at birth (congenital phimosis) and normal appearance of preputial skin. Pathological phimosis refers to failure to retract the foreskin due to distal scarring of the prepuce (European Association of Urology Guideline 2018; McGregor 2007; NICE‐accredited Commissioning Guide 2016; Rickwood 1999; Shankar 1999). On physical examination, scarring may appear as a contracted, white, indurated, fibrous ring around the preputial orifice. Scarring of the prepuce can be secondary to balanitis xerotica obliterans (a chronic, progressive inflammatory disease of the skin of unknown etiology), recurrent episodes of balanoposthitis, or forceful retraction of the prepuce. The estimated cumulative incidence of pathological phimosis in boys aged up to 18 years is between 0.6% and 1.5%, and this condition rarely occurs in boys aged under five years (Rickwood 1999). Studies reporting histological diagnosis of circumcised prepuces in boys have reported an incidence of 34% to 40% of balanitis xerotica obliterans (Boksh 2017; Jasaitiene 2008; Kiss 2005; Yardley 2007). Balanitis xerotica obliterans is more common in older children (over nine years) and boys with acquired phimosis (phimosis developed after a period of normal retraction of foreskin). In boys with suspected balanitis xerotica obliterans on clinical examination, 89% had histological confirmation of the diagnosis, and of those with histological diagnosis of balanitis xerotica obliterans, 47% had non‐pathological phimosis on clinical examination (Yardley 2007). However, children with balanitis xerotica obliterans still represent a very small group among children with phimosis seen in ambulatory or primary care settings.

It is important to differentiate phimosis from balano‐preputial adhesions. In phimosis, unretractability of the prepuce over the glans is due to a stenotic distal portion of the prepuce. In small children, the foreskin may not be fully retractable because of inner preputial adhesions to the glans. Balano‐preputial adhesions correspond to persistent areas of embryologic fusion of the glans to the inner preputial epithelium. These adhesions are still present in most boys at the age of six years and in 3% of boys at 15 years, but disappear by 18 years (Oster 1968). As a normal condition not associated with complications, balano‐preputial adhesions require no treatment.

Despite the theoretical distinction between physiological and pathological phimosis, it can be difficult to distinguish the two types in clinical practice. In some cases, a clinical diagnosis of physiological phimosis may be revised to balanitis xerotica obliterans following circumcision and histological examination of the prepuce (Boksh 2017; European Association of Urology Guideline 2018; Kiss 2005).

Indications for treating phimosis are controversial. Most experts agree that asymptomatic physiological phimosis should be left to resolve spontaneously until puberty, and only true pathological phimosis requires treatment. However, many consider that recurrent episodes of balanoposthitis, recurrent paraphimosis, and urinary tract infections (UTIs) are indications for treatment of physiological phimosis at an earlier age (Canadian Urological Association Guideline 2017; European Association of Urology Guideline 2018; NICE‐accredited Commissioning Guide 2016).

The traditional treatment options for phimosis are circumcision and, more recently, prepuce plasty (Dawson 1996; European Association of Urology Guideline 2001). However, since the 1990s, several studies have assessed conservative treatments for phimosis with topical corticosteroids applied to the stenotic distal portion of the prepuce for four to eight weeks, with high rates of resolution (Chu 1999; Golubovic 1996; Kikiros 1993; Jorgensen 1993; Lindhagen 1996; Monsour 1999). Three cost‐effectiveness studies based on randomized and non‐randomized studies have recommended topical corticosteroids for the initial treatment of phimosis before any surgical intervention (Berdeu 2001; Nobre 2010; Van Howe 1998). Guidelines published in the late 2010s also recommend the use of topical corticosteroids as the first‐line treatment of phimosis (Canadian Urological Association Guideline 2017; European Association of Urology Guideline 2018; NICE‐accredited Commissioning Guide 2016).

Description of the intervention

Topical corticosteroids of different potency and at different concentrations have been used in the treatment of physiological and pathological phimosis. This treatment involves the application of corticosteroid ointment to the stenotic distal portion of the prepuce, sometimes associated with gentle manual retraction of the foreskin. Most studies use corticosteroids for four to eight weeks and encourage participants to continue retracting their foreskin and to maintain adequate hygiene after completing treatment.

How the intervention might work

Corticosteroids may act by the following two mechanisms in the resolution of phimosis (Kikiros 1993; Marques 2005; Shankar 1999; Zampieri 2007).

Anti‐inflammatory action: through the stimulation of lipocortin production, corticosteroids inhibit phospholipase A2, thus reducing the production of arachidonic acid, which is a precursor of prostaglandins and leukotrienes (mediators of skin inflammation). Corticosteroids reduce early manifestations of inflammation (edema, fibrin deposition, capillary dilation, migration of leucocytes, and phagocyte activity) and late manifestations of inflammation (proliferation of capillaries and fibroblasts, depletion of collagen, and cicatrization).
Immunosuppressive effects: corticosteroids produce skin thinning and increase skin elasticity by inhibiting epidermal proliferation and collagen synthesis by fibroblasts

Histologic studies have shown that most prepuces circumcised in boys with phimosis have balanitis xerotica obliterans or nonspecific chronic inflammation (Boksh 2017; Jasaitiene 2008; Kiss 2005; Shankar 1999; Yardley 2007). Chronic inflammation was the predominant finding in younger age groups, and balanitis xerotica obliterans was most common in boys older than nine to eleven years (Kiss 2005; Yardley 2007). In one randomized controlled trial (RCT) that investigated the response of balanitis xerotica obliterans to the local application of 0.05% mometasone ointment, all children were circumcised at the end of the study (Kiss 2001). Only those with early or intermediate forms of balanitis xerotica obliterans responded to corticosteroid treatment, suggesting that local steroids are effective when inflammation mechanisms are active and no irreversible tissue damage has occurred.

Why it is important to do this review

Despite the controversy regarding the appropriate medical indications for the treatment of phimosis (Farshi 2000; McGregor 2007; Rickwood 1999), many boys are still being circumcised for this condition (Cathcart 2006; Rickwood 2000; Spilsbury 2003). It is crucial to educate physicians and parents about the natural course of physiological phimosis and the recognition of pathological phimosis to reduce unnecessary interventions (Boksh 2017; NICE‐accredited Commissioning Guide 2016).

Considering only absolute indications for circumcision (pathological phimosis affecting up to 1.5% of boys in primary care [Rickwood 1999]), and the most common relative indications (recurrent balanoposthitis, recurrent UTIs, and recurrent paraphimosis), many boys younger than 18 years could require circumcision (Rickwood 1999). This poses an important burden to any health system (Berdeu 2001; NICE‐accredited Commissioning Guide 2016; Nobre 2010; Van Howe 1998).

Surgery for phimosis has risks: between 0.1% and 3.5% of operations are associated with complications, including hemorrhage, stenotic meatitis, meatal ulceration, postoperative local infections, and anesthesia‐related adverse events, as well as the psychological stress for children and their parents (Cathcart 2006).

In this scenario, a conservative approach with different types of topical corticosteroids for the initial treatment of phimosis in boys may be a valid alternative. Despite a growing number of publications about the use of topical corticosteroids for phimosis and some cost‐effectiveness studies, there was a need for a systematic review of RCTs to summarize the evidence on the effectiveness of topical corticosteroids in this population. This is an update of our previous systematic review (Moreno 2014). We applied up‐to‐date Cochrane methodological standards, including a comprehensive literature search, inclusion of clinically relevant outcomes, and rating of the certainty of evidence on a per‐outcome basis using GRADE.

Objectives

To assess the effects of topical corticosteroids applied to the stenotic portion of the prepuce for the treatment of phimosis in boys compared with placebo or no treatment.

Methods

Criteria for considering studies for this review

Types of studies

We included RCTs comparing the use of any topical corticosteroid ointment with placebo ointment or no treatment in boys with phimosis.

Types of participants

We included studies of boys from birth to 18 years of age, with any degree of physician‐diagnosed phimosis, where their clinician was considering active treatment. Descriptions of the degree of retractability and type of phimosis (pathological or physiological, acquired or congenital) were not inclusion criteria.

We excluded studies that enrolled boys with non‐retractable prepuce due to balano‐preputial adhesions without a phimotic ring, or boys with previous treatments for phimosis (e.g. circumcision, prepuce plasty, topical corticosteroids, or other topical medication).

Types of interventions

Eligible interventions involved use of a corticosteroid ointment (of any type, at any concentration) applied to the stenotic portion of the prepuce (for any length of time). Eligible comparators were placebo ointment or no treatment.

Concomitant interventions, such as gentle manual retraction of the prepuce, were considered co‐interventions and had to be applied to both intervention and control group similarly to establish fair comparisons.

If a trial included multiple arms, we included any arm that met our eligibility criteria.

Types of outcome measures

We included studies assessing any of the following primary or secondary outcomes.

Primary outcomes

Complete resolution of phimosis (dichotomous outcome)

Secondary outcomes

Partial resolution of phimosis (dichotomous outcome)
Change in retractability score (continuous outcome)
Long‐term complete resolution of phimosis (dichotomous outcome)
Local or systemic adverse effects (irritation, local infection, skin damage, Cushing syndrome) associated with the use of topical corticosteroids in the prepuce (dichotomous outcome)

Method and timing of outcome measurements

Complete resolution of phimosis

Defined as a retractable prepuce with total exposure of the glans, without any visible narrowing, assessed by a physician's clinical evaluation. Unretractability of the prepuce due only to balano‐preputial adhesions in the absence of a phimotic ring was not considered a failure.
Assessed immediately after the treatment period
Minimum clinically important difference (MCID): 5% absolute difference

Partial resolution of phimosis

Defined as any improvement of phimosis without total exposure of the glans, assessed by a physician's clinical evaluation
Assessed immediately after the treatment period
MCID: 5% absolute difference

Change in retractability score

Defined as the difference in mean score before treatment compared to the mean score after treatment, assessed by a physician's clinical evaluation
Assessed immediately after the treatment period
MCID: standardized mean difference (SMD) of 0.3

Long‐term complete resolution of phimosis

Defined as a retractable prepuce with total exposure of the glans, without any visible narrowing, assessed by a physician's clinical evaluation.
Assessed at least six months after completion of treatment.
MCID: 5% absolute difference.

Local or systemic adverse events

Any self‐reported local or systemic adverse event
Assessed immediately after the treatment period
MCID: 5% absolute difference

Search methods for identification of studies

We performed a comprehensive search with no restrictions on the language of publication or publication status. We repeated searches three months before anticipated publication of the review.

Electronic searches

We searched the following electronic sources.

Cochrane Central Register of Controlled Trials (CENTRAL; 2023, issue 10) in the Cochrane Library (searched 4 October 2023)
MEDLINE Ovid (1946 to 4 October 2023)
Embase.com (1974 to 4 October 2023)
LILACS (Latin American and Caribbean Health Science Information database; 1982 to 4 October 2023)
US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (www.clinicaltrials.gov; searched 4 October 2023)

See Appendix 1 for search terms used in strategies for this review.

Searching other resources

To identify other potentially eligible trials or ancillary publications, we searched the reference lists of included studies and of relevant systematic reviews, health technology assessment reports, and clinical practice guidelines. In addition, we contacted authors of included trials to inquire whether they knew of any other trials we may have missed.

Data collection and analysis

Two review authors independently collected and analyzed all data, as per the recommendations of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2019).

Selection of studies

We used Covidence to identify and remove duplicate records. Two review authors (CR, JC) independently scanned the abstract, title, or both, of all remaining records and eliminated those that were clearly ineligible. After we had retrieved the full‐text reports of all remaining records, the same two review authors (CR, JC) read through each one, mapped records to studies, and classified studies as included, excluded, awaiting classification, or ongoing, according to the criteria provided in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2019). We resolved discrepancies through consensus or recourse to a third review author (GM). If resolution of a disagreement was not possible, we designated the study 'awaiting classification' and contacted the study authors for clarification. We documented reasons for exclusion of studies that readers may reasonably have expected to be included in the review in a Characteristics of excluded studies table. We documented the selection process in sufficient detail to complete a PRISMA flow diagram (Moher 2009).

Data extraction and management

We developed and piloted a dedicated data extraction form.

Two review authors (GM, JC) independently extracted the following information from included studies (see Characteristics of included studies table).

Study design
Study dates
Study settings and country
Participant inclusion and exclusion criteria (e.g. age, severity of phimosis)
Participant details, baseline demographics (e.g. age, severity of phimosis)
Number of participants in each study and by study arm
Details of relevant experimental and comparator interventions (e.g. type of steroid, dose, frequency, duration)
Definitions of relevant outcomes, and method and timing of outcome measurement, as well as any relevant subgroups
Study funding sources
Declarations of interest by primary investigators
Study characteristics relevant to risk of bias assessment

We extracted outcome data relevant to this review as needed to calculate summary statistics and measures of variance. For dichotomous outcomes, we obtained numbers of events and totals for the population to complete a 2 × 2 table, as well as summary statistics with corresponding measures of variance. For continuous outcomes, we obtained means and standard deviations (SDs) or the data necessary to calculate means and SDs.

We resolved disagreements by discussion, or, if required, by consulting a third review author (TP).

We provided information about potentially relevant ongoing studies, including trial identifier, in the Characteristics of ongoing studies table.

We attempted to contact authors of included studies to obtain key missing data as needed.

Studies reported in non‐English and non‐Spanish language journals were translated before assessment. In the event of duplicate publications, companion documents, or multiple reports of a primary study, we maximized the yield of information by mapping all publications to unique studies and collating all available data using the most complete data set aggregated across all known publications.

Assessment of risk of bias in included studies

Two review authors (CR, BP) independently assessed the risk of bias of each included study using the Cochrane risk of bias tool (RoB 1; Higgins 2011). We resolved disagreements by consensus or by consulting a third review author (GM), if necessary.

Rob 1 includes the following domains (see Appendix 2).

Random sequence generation (selection bias)
Allocation concealed (selection bias)
Blinding of participants and personnel (performance bias)
Blinding of outcome assessors (detection bias)
Incomplete outcome data (attrition bias)
Selective outcome reporting (reporting bias)
Other sources of bias

For all domains except attrition bias, we considered all outcomes equally susceptible to bias and assessed them as one group. We assessed attrition bias on an outcome‐specific basis. We grouped together complete resolution of phimosis, partial resolution of phimosis, and change in retractability score, as all were measured at the end of the treatment period. We evaluated risk of attrition bias separately for long‐term complete resolution of phimosis and adverse effects, as these outcomes were measured at different time points.

We judged each study at low risk, high risk, or unclear risk of bias for each domain, as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We created a risk of bias summary to illustrate these findings.

We further summarized the risk of bias across domains for each outcome in each included study, as well as across studies and domains for each outcome, in accordance with the approach for summary assessments of risk of bias presented in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

Measures of treatment effect

For dichotomous outcomes (such as complete or partial resolution), we expressed results as risk ratios (RRs) with 95% CIs. For our continuous outcome (change in retractability score), we planned to use mean difference (MD) or standardized mean difference (SMD) with 95% CIs. Because studies used different scales to measure preputial retractability, we used the SMD.

Unit of analysis issues

The unit of analysis was the individual participant. If we had included any cross‐over trials, we would only have considered data up to the time point that cross‐over occurred, in accordance with guidance provided in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2019).

Dealing with missing data

If possible, we sought to obtain missing data from study authors and perform intention‐to treat analysis where data were available; otherwise, we performed available‐case analysis. We investigated attrition rates (e.g. dropouts, losses to follow‐up, withdrawals) and critically appraised issues of missing data. We did not impute missing data.

Assessment of heterogeneity

We assessed the presence of statistical heterogeneity using a Chi² test on N − 1 degrees of freedom (where N was the number of studies), with an alpha of 0.05 for statistical significance. We also calculated the I² statistic, which describes the percentage of the variability in effect estimates that is due to heterogeneity rather than sampling error (Higgins 2003). We interpreted I² statistics as follows.

0% to 40%: might not be important.
30% to 60%: may represent moderate heterogeneity.
50% to 90%: may represent substantial heterogeneity.
75% to 100%: represents considerable heterogeneity.

We explored possible reasons for heterogeneity by examining individual study and subgroup characteristics (see Subgroup analysis and investigation of heterogeneity).

Assessment of reporting biases

We attempted to obtain study protocols to assess selective outcome reporting.

Where we included 10 or more studies in a meta‐analysis, we used funnel plots to assess small‐study effects, such as publication bias.

Data synthesis

We summarized data using a random‐effects model. We used this model because of the expected clinical heterogeneity in the population (e.g. age range, degree and type of phimosis), interventions (e.g. type of corticosteroid, duration of treatment), and outcomes (different measurement scales). We interpreted random‐effects meta‐analyses with due consideration of the whole distribution of effects. In addition, we performed statistical analyses according to the statistical guidelines contained in the Cochrane Handbook of Systematic Reviews of Interventions (Higgins 2019). For dichotomous outcomes, we used the Mantel‐Haenszel method; for continuous outcomes, we used the inverse variance method. We used Review Manager Web for all analyses (RevMan Web 2022).

Subgroup analysis and investigation of heterogeneity

Where sufficient data were available, we explored plausible explanations for variations in treatment effects (statistical heterogeneity) using subgroup analysis (Sun 2010). We planned to perform the following predefined subgroup analyses, based on characteristics that we expected would introduce heterogeneity.

Age of participants (three years and older versus younger than three years)
Severity of phimosis (complete versus partial phimosis)
Type of phimosis (physiological versus pathological)
Type of corticosteroids (high versus medium versus low potency)
Use of manual retraction of the prepuce (yes versus no)
Duration of treatment (four versus eight weeks)

Sensitivity analysis

We planned to perform sensitivity analysis based on risk of bias by excluding studies judged to be at high or unclear risk of bias for the primary outcome.

Summary of findings and assessment of the certainty of the evidence

We presented the overall certainty of the evidence for each outcome according to the GRADE approach, which takes into account criteria related to internal validity (risk of bias, inconsistency, imprecision, publication bias) and external validity (directness of results; Guyatt 2008). Two review authors (GM, TP) independently rated the certainty of evidence for each outcome as 'high', 'moderate', 'low', or 'very low' using GRADEpro GDT. We resolved any discrepancies by consensus or by involving a third review author (BP), if needed. For each comparison, we presented a summary of the evidence for the main outcomes in a summary of findings table, which provides the best estimate of the magnitude of the effect in relative and absolute terms, the numbers of participants and studies addressing each important outcome, and the rating of the overall confidence in effect estimates for each outcome (Guyatt 2011; Schünemann 2011).

We included the following outcomes in the summary of findings table.

Complete resolution of phimosis
Partial resolution of phimosis
Change in retractability score
Long‐term complete resolution of phimosis
Adverse effects

See Table 1.

Results

Description of studies

Results of the search

The literature search identified 3526 records. After deduplication, we screened 724 records, of which we excluded 696. During full‐text assessment of the 28 potentially eligible reports, we identified 14 eligible studies. Figure 1 is a PRISMA diagram showing the flow of literature through this process.

Included studies

For details of the populations and interventions of the 14 studies (1459 randomized participants) included in this systematic review, see the Characteristics of included studies table. Table 2 (baseline characteristics) and Table 3 (description of interventions) provide further details.

1. Baseline characteristics of included studies.

Study	Intervention(s) and comparator(s)	Duration of intervention/ follow‐up	Description of participants	Trial period	Country	Setting
Balamtekin 2006	I: beclomethasone dipropionate 0.05%	Intervention: 6 weeks Follow‐up: same as intervention	Boys aged 2–8 years with difficulties urinating, forced urination, short urinary stream, preputial ballooning, and Kikiros grade 3–5 phimosis	January 2003–September 2004	Turkey	Outpatients
	C: manual retraction and hygiene
Chao 2006	I: betamethasone 0.1%	Intervention: 4 weeks Follow‐up: 25 weeks	Boys aged 3–17 years with > Kikiros grade 2 phimosis	Not reported	China	Not reported
	C: aqueous cream
Diaz Berrocal 2006	I: hydrocortisone 0.5%	Intervention: 4 weeks Follow‐up: 8 weeks	Pediatric patients < 9 years with pathological phimosis, and > 9 years with any type of phimosis	Not reported	Colombia	Outpatients
	C: placebo cream
Esposito 2008	I: mometasone furoate 0.1%	Intervention: 4 weeks Follow‐up: median 20 months (range 6–30 months)	Boys aged 36 months–13 years with grade III–V phimosis (grade III: exposure of the urethral meatus; grade IV: slight retraction without exposure of the glans; grade V: no foreskin retraction)	June 2003–May 2005	Italy	Outpatients
	C: placebo cream
Golubovic 1996	I: betamethasone 0.05%	Intervention: 4 weeks Follow‐up: mean 10.5 months (range 6–18 months)	Boys aged 3–6 years with phimosis, defined as an unretractable foreskin with no adhesions but a circular band of constriction making complete retraction impossible	October 1994–October 1995	Yugoslavia	Outpatients
	C: neutral cream (petroleum jelly)
Kiss 2001	I: mometasone furoate 0.05%	Intervention: 5 weeks Follow‐up: same as intervention	Boys aged 5–15 years with balanitis xerotica obliterans diagnosed clinically by typical macroscopic findings	Not reported	Hungary	Outpatients
	C: placebo ointment
Lee 2006	I: hydrocortisone butyrate 0.1%	Intervention: 4 weeks Follow‐up: same as intervention	Full‐term male infants who were treated for UTI and found to have non‐retractile physiologic phimosis	August 2002–July 2003	South Korea	Outpatients
	C: petroleum jelly
Letendre 2009	I: triamcinolone 0.1%	Intervention: 8 weeks Follow‐up: 12 months, until January 2008	Boys aged 3–12 years with grade III–VI persistent or pathological phimosis (grade III: > 1/3 of the glans exposed; grade IV: < 1/3 of the glans exposed; grade V: small opening of the prepuce over the glans without retraction; grade VI: no retraction)	June 2005–January 2007	Canada	Outpatients
	C: emollient cream (Aquatain)
Lindhagen 1996	I: clobetasol propionate 0.05% (Dermovate, Glaxo)	Intervention: 4–8 weeks Follow‐up: 6 months	Boys aged 5–12 years with phimosis, defined as unretractable foreskin when no part of the glans penis could be inspected despite retraction of the prepuce to the point where it began to fissure.	April 1993–April 1994	Sweden	Outpatients
	C: placebo ointment
Lund 2005	I: betamethasone 0.1% (Betnovate cream, Glaxo)	Intervention: 4 weeks Follow‐up: 8 weeks	Boys with grade 4–6 phimosis (grade 4: partial exposure of glans (< 1/3); grade 5: partial retraction, pinhole opening of prepuce; grade 6: absolutely no retraction), who were on the waiting list for circumcision	Not reported	China	Outpatients
	C: aqueous cream
Nascimento 2011	I1: betamethasone valerate 0.2%	Intervention: 8 weeks. Follow‐up: 240 days	Boys aged 3–10 years referred from primary care facilities to the clinic with clinical diagnosis of phimosis	August 2006–November 2007	Brazil	Outpatients
	I2: betamethasone valerate 0.1%
	C: placebo
Pileggi 2007	I: mometasone furoate 0.1%	Intervention: 4 weeks Follow‐up: 8 weeks	Boys aged 2–13 years with symptomatic phimosis and referred to surgery, presenting with Kikiros retractability grade 5 phimosis.	Not reported	Brazil	Outpatients
	C: moisturizing cream
Romero‐Cortes 2018	I: hydrocortisone 1%	Intervention: 8 weeks Follow‐up: same as intervention	Infants aged 30–60 days with Kayaba's grade 1 or 2 physiologic phimosis	October 2017–January 2018	Mexico	Outpatients
	C: petroleum jelly
Yilmaz 2003	I: betamethasone 0.05%	Intervention: 1 or 2 months Follow‐up: 2 months	Boys aged 3–6 years with phimosis, defined as narrowing of the opening of foreskin, which makes it difficult to retract the foreskin to the coronal sulcus.	December 1999–June 2002	Turkey	Outpatients
	C: petroleum jelly

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C: comparator; I: intervention; SD: standard deviation; UTI: urinary tract infection.

2. Description of interventions in included studies.

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C: comparator; I: intervention; CoI: co‐intervention.

The studies were carried out in 11 countries: Turkey (N = 2), China (N = 2), Brazil (N = 2), Italy (N = 1), Yugoslavia (N = 1), Hungary (N = 1), South Korea (N = 1), Canada (N = 1), Sweden (N = 1), Colombia (N = 1), and Mexico (N = 1). The age of participants ranged from 18 days to 17 years.

The corticosteroids used in the intervention groups were betamethasone in five studies (Chao 2006; Golubovic 1996; Lund 2005; Nascimento 2011; Yilmaz 2003), mometasone furoate in three studies (Esposito 2008; Kiss 2001; Pileggi 2007), hydrocortisone in two studies (Diaz Berrocal 2006; Romero‐Cortes 2018), beclomethasone dipropionate in one study (Balamtekin 2006), hydrocortisone butyrate in one study (Lee 2006), triamcinolone in one study (Letendre 2009), and clobetasol propionate in one study (Lindhagen 1996).

The duration of treatment was variable: four weeks in seven studies (Chao 2006; Diaz Berrocal 2006; Esposito 2008; Golubovic 1996; Lee 2006; Lund 2005; Yilmaz 2003), five weeks in one study (Kiss 2001), six weeks in one study (Balamtekin 2006), and eight weeks in five studies (Letendre 2009; Lindhagen 1996; Nascimento 2011; Pileggi 2007; Romero‐Cortes 2018).

For the control intervention, nine studies used an aqueous cream (Chao 2006; Diaz Berrocal 2006; Esposito 2008; Kiss 2001; Letendre 2009; Lindhagen 1996; Lund 2005; Nascimento 2011; Pileggi 2007); four studies used petroleum jelly (Golubovic 1996; Lee 2006; Romero‐Cortes 2018; Yilmaz 2003); and one study used only manual retraction and hygiene (Balamtekin 2006).

Twelve studies used manual retraction of the foreskin as a co‐intervention in both the intervention and the control groups (Chao 2006; Diaz Berrocal 2006; Golubovic 1996; Kiss 2001; Lee 2006; Letendre 2009; Lindhagen 1996; Lund 2005; Nascimento 2011; Pileggi 2007; Romero‐Cortes 2018; Yilmaz 2003). One study used manual retraction of the prepuce only in the control group (Balamtekin 2006), and one study did not use manual retraction at all (Esposito 2008).

Five studies measured their primary outcome at four weeks (Diaz Berrocal 2006; Lee 2006; Lindhagen 1996; Lund 2005; Yilmaz 2003), two at five weeks (Chao 2006; Kiss 2001), one at six weeks (Balamtekin 2006), and five at eight weeks (Letendre 2009; Lindhagen 1996; Nascimento 2011; Pileggi 2007; Romero‐Cortes 2018). Two studies measured their outcomes on a longer timescale: mean 20 months (range 6 to 30 months) in Esposito 2008, and mean 10.5 months (range 6 to 18 months) in Golubovic 1996.

Excluded studies

We excluded 11 studies from this review: seven were not RCTs, and four used an active comparison group. The specific reasons for exclusion are detailed in the Characteristics of excluded studies table. We contacted one study author for further information about the randomization process; in the end we excluded this study (Zampieri 2007).

Ongoing studies

We identified three relevant ongoing RCTs (ISRCTN64387412; EudraCT 2006‐003779‐11; NCT01108198). ISRCTN64387412 was registered in 2005 in the ISRCTN registry; its status is completed, but we found no publications, and we were unable to contact the study authors. EudraCT 2006‐003779‐11 was registered at clinicaltrialsregister.eu in 2006; we found no publications, and we were unable to contact the study authors. NCT01108198 was registered in ClinicalTrials.gov in 2010; it started recruitment in 2006, its current status is unknown, we found no publications, and we were unable to contact the study authors.

Risk of bias in included studies

We were unable to make an informed judgment about risk of bias for most studies owing to insufficient information in their reports (Figure 2; Figure 3). The Characteristics of included studies table provides reasons for each risk of bias decision.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study

Risk of bias graph: review authors' judgements about each risk of bias (methodological quality) item presented as percentages across all included studies

Allocation

Sequence generation

Four studies clearly reported random sequence generation (Diaz Berrocal 2006; Esposito 2008; Nascimento 2011; Romero‐Cortes 2018), and the remaining 10 studies provided insufficient or no information for this domain (Balamtekin 2006; Chao 2006; Golubovic 1996; Kiss 2001; Lee 2006; Letendre 2009; Lindhagen 1996; Lund 2005; Pileggi 2007; Yilmaz 2003).

Allocation concealment

Two studies clearly reported allocation concealment (Lindhagen 1996; Pileggi 2007). In the remaining 12 studies, allocation concealment was unclear (Balamtekin 2006; Chao 2006; Diaz Berrocal 2006; Esposito 2008; Golubovic 1996; Kiss 2001; Lee 2006; Letendre 2009; Lund 2005; Nascimento 2011; Romero‐Cortes 2018; Yilmaz 2003).

Blinding

Blinding of participants and personnel

We judged Balamtekin 2006 at high risk of performance bias because it used no placebo in the control group. Lindhagen 1996 and Pileggi 2007 were at low risk because they were double‐blind trials with a clear description of the blinding method. The remaining 11 studies were described as double‐blind and used placebo, but did not clearly state that participants and personnel were blinded; we therefore judged them at unclear risk of performance bias (Chao 2006; Diaz Berrocal 2006; Esposito 2008; Golubovic 1996; Kiss 2001; Lee 2006; Letendre 2009; Lund 2005; Nascimento 2011; Romero‐Cortes 2018; Yilmaz 2003).

Blinding of outcome assessment

Five studies clearly described blinding of outcome assessment (Esposito 2008; Letendre 2009; Lindhagen 1996; Pileggi 2007; Romero‐Cortes 2018). The remaining nine studies provided no clear description (Balamtekin 2006; Chao 2006; Diaz Berrocal 2006; Golubovic 1996; Kiss 2001; Lee 2006; Lund 2005; Nascimento 2011; Yilmaz 2003).

Incomplete outcome data

Complete resolution of phimosis, partial resolution of phimosis, and change in retractability score

Ten studies measured complete resolution of phimosis, seven studies measured partial resolution of phimosis, and four studies measured change in retractability score. There was a low risk of attrition bias in eight studies (Balamtekin 2006; Diaz Berrocal 2006; Lee 2006; Lund 2005; Romero‐Cortes 2018; Yilmaz 2003), high risk in two (Letendre 2009; Kiss 2001), and unclear risk in four (Chao 2006; Lindhagen 1996; Nascimento 2011; Pileggi 2007).

Long‐term complete resolution of phimosis

Two studies measured complete resolution of phimosis at least 6 months after completing treatment. Esposito 2008, at a median follow‐up of 20 months (range 6 to 30 months), had a low risk of attrition bias. Golubovic 1996, at a mean follow‐up of 10.5 months (range 6 to 18 months), had a low risk of attrition bias.

Adverse effects

Twelve studies measured adverse effects, but one could not be included in the meta‐analysis because it did not specify in which treatment group the adverse events had occurred (Nascimento 2011). Of the eleven studies included in the meta‐analysis, seven were at low risk of attrition bias (Balamtekin 2006; Diaz Berrocal 2006; Esposito 2008; Golubovic 1996; Lee 2006; Lund 2005; Romero‐Cortes 2018), one at high risk (Letendre 2009), and the remaining three at unclear risk (Chao 2006; Kiss 2001; Lindhagen 1996).

Selective reporting

No protocol was available for any studies to judge whether they had reported all important predefined outcomes. For this reason, we considered all studies at unclear risk of reporting bias. In Yilmaz 2003, the study authors stated that they had planned to measure outcomes at three different timelines, but they reported only two timelines without a clear justification.

Other potential sources of bias

The visual examination of the funnel plot corresponding to the meta‐analysis of the primary outcome (complete resolution of phimosis) showed some asymmetry, with small studies showing no 'missed' beneficial effects (Figure 4). We did not perform a statistical test for funnel plot asymmetry because of the limited number of studies and the similarities among standard errors of the intervention effect estimates (Sterne 2011). Even when this could suggest publication bias, there may be other explanations for this asymmetry, such as heterogeneity (probable), poor methodological design, or both.

Funnel plot of comparison 1: topical corticosteroids versus placebo or no treatment; outcome 1.1: complete resolution of phimosis.

We were unable to conduct funnel plot analyses for the outcomes of partial resolution of phimosis or adverse effects due to the paucity of studies.

We detected no other potential sources of bias.

Effects of interventions

See: Table 1

Topical corticosteroids versus placebo or no treatment

Primary outcome

Complete resolution of phimosis

Ten studies (834 participants) reported complete resolution of phimosis after the end of treatment (Balamtekin 2006; Diaz Berrocal 2006; Lee 2006; Letendre 2009; Lindhagen 1996; Lund 2005; Nascimento 2011; Pileggi 2007; Romero‐Cortes 2018; Yilmaz 2003).

Compared with placebo or no treatment, topical corticosteroids may increase complete resolution of phimosis (RR 2.73, 95% CI 1.79 to 4.16; I² = 72%; low‐certainty evidence; Analysis 1.1; Figure 5). The probability of complete resolution in the control group was 25.2%. Therefore, our estimate represents an absolute effect size of 436 more resolutions per 1000 individuals (95% CI 199 more to 796 more). We downgraded the certainty of the evidence for serious study limitations and serious inconsistency (Table 1).

1.1 — Comparison 1: Topical corticosteroids versus placebo or no treatment, Outcome 1: Complete resolution of phimosis

Forest plot of comparison 1: topical corticosteroids versus placebo or no treatment; outcome 1.1: complete resolution of phimosis.

Secondary outcomes

Partial resolution of phimosis

Seven studies (745 participants) reported partial resolution of phimosis (Balamtekin 2006; Chao 2006; Diaz Berrocal 2006; Lee 2006; Letendre 2009; Nascimento 2011; Romero‐Cortes 2018).

Compared with placebo or no treatment, topical corticosteroids may increase partial resolution of phimosis (RR 1.68, 95% CI 1.17 to 2.40; I² = 44%, low‐certainty evidence; Analysis 1.2). The probability of partial resolution in the control group was 29.7%. Therefore, our estimate represents an absolute effect size of 202 more partial resolutions per 1000 individuals (95% CI 50 more to 416 more). We downgraded the certainty of the evidence for serious study limitations and serious inconsistency (Table 1).

1.2 — Comparison 1: Topical corticosteroids versus placebo or no treatment, Outcome 2: Partial resolution of phimosis

Change in retractability score

Four studies reported change in retractability score using different measurement scales: Kikiros phimosis grading score (Chao 2006), Kabaya's classification of phimosis (Romero‐Cortes 2018), Meuli grading score for phimosis in balanitis xerotica obliterans (Kiss 2001), and their own phimosis grading score (Lund 2005). Chao 2006 reported only the mean scores for each group without SD/variance, and Romero‐Cortes 2018 only reported results as medians and ranges.

All four studies reported improvement in retractability scores. In Chao 2006, which recorded Kikiros retractability score from grade 0 (full retraction) to grade 5 (absolutely no retraction), the mean retractability score decreased from 3.68 to 2.21 in the corticosteroid steroid group, and from 3.73 to 2.90 in the placebo group after four weeks of treatment. Romero‐Cortes 2018 recorded Kayaba's retractability score (type 1 [no retraction] to type V [easy exposure of whole glans]) and reported changes from a median of 1 (range 1 to 2) to 3 (range 2 to 4) in the steroid group and from a median of 1 (range 1 to 2) to 2 (range 1 to 4) in the placebo group after eight weeks of treatment. In Kiss 2001, which used the Meuli grading scale (grade 1 [complete preputial retractability] to grade 4 [no retractability]), mean scores decreased from 3.35 (SD 0.15) to 2.94 (SD 0.18) in the steroid group and from 3.00 (SD 0.20) to 3.38 (SD 0.20) in the placebo group after five weeks of treatment. In Lund 2005, which used a grading scale from grade 1 (full retraction) to grade 6 (absolutely no retraction), mean retractability scores decreased from 5.08 (SD 0.66) to 2.38 (SD 1.41) in the steroid group and from 4.97 (SD 0.70) to 3.55 (SD 1.55) in the placebo group after four weeks of treatment. We carried out a meta‐analysis with the two studies that provided sufficient data (Kiss 2001; Lund 2005), obtaining an SMD of −1.48 (95% CI −2.93 to −0.03; I²= 91%; 177 participants; Analysis 1.3). The point estimate corresponds to a large effect (Schünemann 2019), but a small difference cannot be excluded. We rated the certainty of evidence as very low, downgrading for serious study limitations, serious heterogeneity, and serious imprecision (Table 1). Therefore, it is uncertain if topical corticosteroids affect retractability of the prepuce compared to placebo.

1.3 — Comparison 1: Topical corticosteroids versus placebo or no treatment, Outcome 3: Change in retractability score

Long‐term complete resolution of phimosis

Six studies had a follow‐up period of at least six months after treatment (Chao 2006; Esposito 2008; Golubovic 1996; Letendre 2009; Lund 2005; Nascimento 2011). However, we were unable to evaluate long‐term complete resolution of phimosis in four studies because they did not maintain the randomized interventions until the end of follow‐up: after the treatment period, all boys whose allocated treatment had been unsuccessful were offered corticosteroids (Chao 2006; Letendre 2009; Lund 2005) or circumcision (Nascimento 2011).

Only two studies (280 participants) maintained the randomized interventions until the end of follow‐up and were included in our meta‐analysis (Esposito 2008; Golubovic 1996). Compared with placebo or no treatment, topical corticosteroids may increase long‐term complete resolution of phimosis (RR 4.09, 95% CI 2.80 to 5.97; I² = 0%; low‐certainty evidence; Analysis 1.4). The probability of complete resolution in the control group was 17.1%. Therefore, our estimate represents an absolute effect size of 529 more resolutions per 1000 individuals (95% CI 308 more to 850 more). We downgraded the certainty of the evidence for serious study limitations and serious imprecision (Table 1).

1.4 — Comparison 1: Topical corticosteroids versus placebo or no treatment, Outcome 4: Long‐term complete resolution of phimosis

Adverse effects

Twelve studies measured and reported the occurrence of adverse effects (Balamtekin 2006; Chao 2006; Diaz Berrocal 2006; Esposito 2008; Golubovic 1996; Kiss 2001; Lee 2006; Letendre 2009; Lindhagen 1996; Lund 2005; Nascimento 2011 Romero‐Cortes 2018). Only two studies reported the occurrence of adverse effects per study arm (Diaz Berrocal 2006; Romero‐Cortes 2018). Adverse effects occurred in one boy in the intervention group (telangiectasis and contact eczema) and six boys in the control group (one telangiectasis, three lacerations, and two inflammations). Nascimento 2011 reported adverse effects in three boys (two balanoposthitis and one paraphimosis), without specifying the group they were in; we could not include this study in our meta‐analysis. Nine studies reported that none of their participants presented adverse effects (Balamtekin 2006; Chao 2006; Esposito 2008; Golubovic 1996; Kiss 2001; Lee 2006; Letendre 2009; Lindhagen 1996; Lund 2005). The remaining two studies made no mention of adverse effects in their publications (Pileggi 2007; Yilmaz 2003).

There may be little or no difference in the risk of adverse effects between topical corticosteroids and placebo or no treatment (RR 0.28, 95% CI 0.03 to 2.62; I² = 22%; 11 studies, 1091 participants; low‐certainty evidence; Figure 6; Analysis 1.5). The risk in the control group was 1.1%. Therefore, our estimate corresponds to eight fewer adverse effects per 1000 individuals in the treatment group (95% CI 11 fewer to 18 more). We downgraded the certainty of the evidence for serious study limitations and serious imprecision (Table 1).

Forest plot of comparison 1: topical corticosteroids versus placebo; outcome 1.7: adverse effects (any).

1.5 — Comparison 1: Topical corticosteroids versus placebo or no treatment, Outcome 5: Adverse effects (any)

Subgroup analyses

Complete resolution of phimosis: predefined subgroup analysis by age (younger than three years versus three years or older)

The test for subgroup differences was statistically significant (P = 0.04). Differences between the effect sizes for boys younger than three years of age (RR 6.27, 95% CI 2.63 to 14.94; I² = 0%; 2 studies, 120 participants) and those aged three years or older (RR 2.32, 95% CI 1.55 to 3.47; I² = 70%; 8 studies, 714 participants) may not be attributable to chance, with complete resolution of phimosis occurring more frequently in the younger children (Analysis 1.6).

1.6 — Comparison 1: Topical corticosteroids versus placebo or no treatment, Outcome 6: Complete resolution of phimosis (subgroup analysis based on age)

Complete resolution of phimosis: predefined subgroup analysis by duration of treatment (four weeks versus six to eight weeks)

The test for subgroup differences did not meet statistical significance (P = 0.16). Differences between the effect sizes for boys treated for four weeks (RR 4.80, 95% CI 1.38, to 16.66; I² = 88%; 4 studies, 386 participants) and those treated for six to eight weeks (RR 1.92, 95% CI 1.35 to 2.73; I² = 35%; 6 studies; 448 participants) may be attributable to chance (Analysis 1.7).

1.7 — Comparison 1: Topical corticosteroids versus placebo or no treatment, Outcome 7: Complete resolution of phimosis (subgroup analysis based on duration of treatment)

Complete resolution of phimosis: predefined subgroup analysis by corticosteroid potency (high versus medium versus low)

The test for subgroup differences did not meet statistical significance (P = 0.32). Differences between the effect sizes for boys treated with a high‐potency corticosteroid (RR 2.67, 95% CI 1.37 to 5.19; I² = 81%; 5 studies, 459 participants), those treated with a medium‐potency corticosteroid (RR 2.49, 95% CI 1.21 to 5.11; I² = 70%; 3 studies; 264 participants), and those treated with a low‐potency corticosteroid (RR 8.17, 95% CI 2.00 to 33.40; I² = 0%; 2 studies, 111 participants) may be attributable to chance (Analysis 1.8).

1.8 — Comparison 1: Topical corticosteroids versus placebo or no treatment, Outcome 8: Complete resolution of phimosis (subgroup analysis based on potency of corticosteroid)

Other predefined subgroup analyses

We were unable to perform subgroup analysis for the remaining predefined variables (severity of phimosis, type of phimosis, use of preputial retraction) owing to lack of usable data. Six studies did not report severity of phimosis (Diaz Berrocal 2006; Golubovic 1996; Lee 2006; Lindhagen 1996; Lund 2005; Pileggi 2007), seven reported the proportion of different grades of phimosis (Balamtekin 2006; Chao 2006; Esposito 2008; Letendre 2009; Nascimento 2011; Romero‐Cortes 2018; Yilmaz 2003), and Kiss 2001 provided a mean score of phimosis. Regarding type of phimosis (physiological or pathological), Kiss 2001 included only pathological phimosis (balanitis xerotica obliterans), Diaz Berrocal 2006 and Letendre 2009 included physiological and pathological phimosis, Lee 2006 included only physiological phimosis, and all other studies did not clearly state whether they had included pathological phimosis. All studies except Esposito 2008 used preputial retraction. Balamtekin 2006 used retraction only in the control group, and the remaining 12 studies reported the use of preputial retraction in both treatment and control groups.

Sensitivity analyses

We were unable to conduct a sensitivity analysis based on risk of bias, as all studies had similar methodological limitations.

Discussion

Summary of main results

We included 14 studies with 1459 randomized participants. Compared to placebo or no treatment, topical corticosteroids may increase the probability of both complete and partial resolution of the phimotic foreskin when assessed after four to eight weeks of treatment. Topical corticosteroids may also increase the probability of long ‐term complete resolution of phimosis assessed at 6 or more months after treatment. It is uncertain if topical corticosteroids affect retractability scores compared to placebo, and there may be little or no difference in the risk of adverse effects between topical corticosteroids and placebo or no treatment. A predefined subgroup analysis of complete resolution of phimosis based on age (less than 3 years versus three years or more) suggested that topical corticosteroids may be more effective in younger boys. Subgroup analyses based on duration of treatment and potency of corticosteroids suggested no subgroup effect.

Our results should be interpreted with caution (as reflected in the certainty of evidence) because of the study limitations and high clinical heterogeneity.

Overall completeness and applicability of evidence

This systematic review included a wide spectrum of participants (boys of different ages, from 18 days to 17 years, with different types and severity of phimosis) and corticosteroids of different potencies. This contributes to a high degree of heterogeneity but increases the generalizability of the results. However, with the available evidence, we were unable to comprehensively explore the heterogeneity found in the effect estimates. We were only able to run some of the planned subgroup analyses due to limitations in the reporting and the number of available studies. It was not possible to assess whether certain subgroups of participants (e.g. physiological versus pathological phimosis or complete versus partial phimosis) could obtain benefits beyond the average across studies.

All studies were conducted in ambulatory hospital settings; participants were referred to outpatient urologic or pediatric surgery clinics. This does not represent the overall population of boys with phimosis; however, it represents those with an indication for an active intervention. Studies were from a variety of different countries and cultures, meaning the evidence summarized in this review is broadly applicable to different settings both in high‐ and low‐ to middle‐income countries.

Quality of the evidence

The certainty of evidence when assessed using GRADE on a per‐outcome basis was either low or very low. The reasons for downgrading were as follows.

Study limitations: most studies had poor reporting, and it was unclear to what extent they had correctly applied methodological safeguards against bias (e.g. allocation concealment; blinding of participants, personnel, and outcome assessors). In addition, the risk of attrition bias was often unclear.
Inconsistency: for all outcomes except long‐term resolution and adverse effects, we observed unexplained heterogeneity. In accordance with GRADE guidance, this reduced our confidence in the pooled effect size.
Imprecision: for the outcomes of change in retractability scores, long‐term complete resolution of phimosis, and adverse effects, the CIs were wide and crossed predefined thresholds for MCIDs.

Potential biases in the review process

Our review had the following two main limitations.

Comprehensiveness of the search strategy: although we included published and unpublished studies and applied no language restrictions, there was some evidence of publication bias (funnel plot asymmetry; Figure 4) that should be further explored. We contacted some study authors to request more details about their studies and ask whether they knew of any additional studies, but the response rate was limited: one response led to a study exclusion (Zampieri 2005; Zampieri 2007), and the other provided no more precise data (Chao 2006).
Limitations in the risk of bias assessment: the risk of bias assessment was limited by poor reporting in included studies, which is a recognized issue in the urological literature in general (Narayan 2016; Scales 2007), particularly regarding the reporting of harms (Breau 2010).

Agreements and disagreements with other studies or reviews

Our findings are in line with those of other systematic reviews in the field.

Two narrative reviews described the effectiveness of topical corticosteroids in the treatment of phimosis in boys (Bréaud 2005; Miguelez 2006). Given their narrative nature and lack of any efforts to rate the certainty of evidence, their value is limited.

One systematic review published in 2011 (in French) assessed the effectiveness of topical steroid therapy in boys with phimosis (Vorilhon 2011). It included seven RCTs, all of which are also included in our review. It did not include a meta‐analysis and presented all results narratively. Like our review, it showed a higher success rate (complete retraction of the prepuce) in the steroid group (range 53.8% to 95%) compared to the placebo group (range 6.25% to 52%), and these results were statistically significant in six out of seven studies. Only a few local side effects were reported. Vorilhon 2011 stated that the level of evidence was low because of the lack of power in clinical trials and numerous shortcomings and biases in the included studies. However, it provided no GRADE certainty of evidence ratings.

A second systematic review evaluated the same intervention in boys with phimosis, including 11 randomized and non‐randomized trials (Liu 2016). It included a meta‐analysis that indiscriminately pooled across RCTs and non‐RCTs and suggested that steroids may be effective. Other methodological issues include the lack of a previously registered protocol and the use of the obsolete Jadad system for assessing risk of bias. Liu 2016 did not use GRADE or any other approach to assess the quality of evidence on a per‐outcome basis. It concluded that topical steroid therapy was more effective than placebo or the manual retraction method in the treatment of phimosis in children, but this conclusion should be interpreted with caution owing to the serious review limitations.

Authors' conclusions

Implications for practice.

According to the evidence summarized in this review, topical corticosteroids applied to the distal stenotic portion of the prepuce for four to eight weeks, in combination with gentle retraction of the prepuce, and compared with placebo or no treatment, may improve the probability of complete or partial resolution of phimosis after treatment and the long‐term complete resolution of phimosis in boys. Adverse effects appear to be rare, non‐serious, and similar to those seen with placebo.

Researchers can use this important information in cost‐effectiveness evaluations of the use of corticosteroids as the initial treatment of phimosis in boys prior to surgical intervention, and in the development of clinical guidelines for the management of phimosis in boys.

Implications for research.

This review has several important research implications. Although we found a clinically important difference between topical corticosteroids and placebo or no treatment in the resolution of phimosis in boys, our certainty in these results was low, mainly owing to an unclear risk of bias in most included studies, a high level of unexplained statistical heterogeneity between studies, and considerable imprecision in some outcomes.

Further research may increase our certainty in the effects of topical corticosteroids for the treatment of phimosis in boys. Future studies should consider the following points.

Randomized controlled trials require methodological rigor, and their publications should follow sound reporting standards such as those promoted by CONSORT (Schulz 2010).
Preregistration of the study protocol in suitable trial registration databases increases transparency and reduces selective reporting.
Larger sample sizes would lead to more precise estimates of the effect of topical corticosteroids in the treatment of phimosis in boys.
Studies should explore how variables (e.g. age, severity of phimosis, type of phimosis [primary physiological or secondary due to balanitis xerotica obliterans], potency of the corticosteroids used, duration of treatment) can affect the magnitude of treatment results. This would help to explain the important heterogeneity found in this review.
To enable an accurate evaluation of the long‐term effects of corticosteroids, studies should follow participants for at least six months, keeping them in the groups they were randomized to and without breaking the randomization code until the end of the total study period.

What's new

Date	Event	Description
24 January 2024	New search has been performed	Two new studies incorporated into latest update.
24 January 2024	New citation required and conclusions have changed	Results and conclusions were revised based on: an updated search, established minimum clinically important difference (MCID) values, and a change in secondary outcomes.

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History

Protocol first published: Issue 2, 2011 Review first published: Issue 9, 2014

Date	Event	Description
12 January 2024	Amended	Reinstating previous version following publishing error.
4 January 2024	Feedback has been incorporated	All feedback recommendations have been considered and incorporated in final draft.
16 October 2022	New search has been performed	New search, two new citations with 101 participants, conclusions not changed.

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Acknowledgements

We wish to thank the peer‐reviewers for their comments and feedback during the preparation of this review, and the support given by the Cochrane Urology Group.

Appendices

Appendix 1. Electronic search strategies

Database	Search strategy
CENTRAL 2023, Issue 10	MeSH descriptor: [Phimosis] explode all trees MeSH descriptor: [Penis] this term only MeSH descriptor: [Foreskin] this term only MeSH descriptor: [Circumcision, Male] this term only penis:ti,ab,kw (Word variations have been searched) foreskin:ti,ab,kw (Word variations have been searched) prepuce:ti,ab,kw (Word variations have been searched) phmoss:ti,ab,kw (Word variations have been searched) paraphmoss:ti,ab,kw (Word variations have been searched) circumcision:ti,ab,kw (Word variations have been searched) /1 or 10 MeSH descriptor: [Glucocorticoids] explode all trees MeSH descriptor: [Adrenal Cortex Hormones] explode all tres MeSH descriptor: [Steroids] explode all trees steroid:ti,ab,kw (Word variations have been searched) corticoid:ti,ab,kw (Word variations have been searched) corticosteroid:ti,ab,kw (Word variations have been searched) glucocorticoid:ti,ab,kw (Word variations have been searched) betamethasone:ti,ab,kw (Word variations have been searched) clobetasol:ti,ab,kw (Word variations have been searched) triamcinolone:ti,ab,kw (Word variations have been searched) mometasone:ti,ab,kw (Word variations have been searched) MeSH descriptor: [Betamethasone] explode all trees MeSH descriptor: [Clobetasol] this term only MeSH descriptor: [Triamcinolone] explode all trees MeSH descriptor: [Mometasone Furoate] explode all trees Hydrocortisone Triamcinolone Acetonide Aristocort Cinonide Flutex Kena Triac Triderm Kenacort Tricort Volon‐A Elocon Momate Clobex Cormax Embeline Temovate Dermovate Clofenazon Beta‐Val Betaderm Betadexamethasone Betnovate Celestone Celestona Celeston Cellestoderm Diprolene Diprosone Valisone Westcort Locoi Ala‐Cort Hytone Cortaid Cortizone Vanicre Cortifair Cortef Cortri Diprolene® Diprosone® Flubenisone Valisone® Valnac® Westcort Locoid Pandel Ala‐Cort Hytone Nutracort Cortaid Cortizone KeriCort Synacort Instacort MiCort‐HC Vanicream HC Cortifair Corte Cortril /12 or 87 11 and 88
MEDLINE	exp Phimosis/ Penis/ Foreskin/ Circumcision, Male/ penis.tw. foreskin.tw. prepuce.tw. ph#mos#s.tw. paraph#mos#s.tw. circumcision$.tw. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 exp Glucocorticoids/ Adrenal Cortex Hormones/ Steroids/ steroid$.tw. corticoid$.tw. corticosteroid$.tw. glucocorticoid$.tw. betamethasone.tw. clobetasol.tw. triamcinolone.tw. mometasone.tw. exp Betamethasone/ Clobetasol/ exp Triamcinolone/ exp Mometasone Furoate/ Hydrocortisone.tw. Triamcinolone Acetonide.tw. Aristocort.mp Cinonide.mp Flutex.mp Kenalog.mo Triacort.mp Triderm.mp Kenacort.mp Tricort.mp Volon‐A.mp Elocom.mp Momate.mp Clobex.mp Cormax.mp Embeline.mp Temovate.mp Dermovate.mp Clofenazon.mp Beta‐Val.mp Betaderm.mp Betadexamethasone.mp Betnovate.mp Celestone.mp Celestona.mp Celeston.mp Cellestoderm.mp Diprolene.mp Diprosone.mp Valisone.mp Westcort.mp Locoid.mp Ala‐Cort.mp Hytone.mp Cortaid.mp Cortizone.mp Vanicream.mp Cortifair.mp Cortef.mp Cortril.mp 12 or 66 11 and 67 randomized controlled trial.pt. controlled clinical trial.pt. randomized.ab. placebo.ab. drug therapy.fs. randomly.ab. trial.ab. groups.ab. 69 or 76 animals/ not (animals/ and humans/) 77 not 78 68 and 79
EMBASE	phimosis/ penis/ prepuce/ circumcision/ penis.tw. foreskin.tw. prepuce.tw. ph#mos#s.tw. paraph#mos#s.tw. circumcision.tw. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 exp glucocorticoid/ corticosteroid/ steroid/ steroid.tw. corticoid.tw. corticosteroid.tw. glucocorticoid.tw. betamethasone.tw. clobetasol.tw. triamcinolone.tw. mometasone.tw. betamethasone/ clobetasol/ triamcinolone/ mometasone furoate/ Hydrocortisone Triamcinolone Acetonide Aristocort Cinonide Flutex Kena Triac Triderm Kenacort Tricort Volon‐A Elocon Momate Clobex Cormax Embeline Temovate Dermovate Clofenazon Beta‐Val Betaderm Betadexamethasone Betnovate Celestone Celestona Celeston Cellestoderm Diprolene Diprosone Valisone Westcort Locoi Ala‐Cort Hytone Cortaid Cortizone Vanicre Cortifair Cortef Cortri /12 or 66 11 and 67 crossover‐procedure/ double‐blind procedure/ randomized controlled trial/ single‐blind procedure/ (random* or factorial* or crossover* or cross over* or placebo* or (doubl* adj blind) or (singl adj blind) or assign or allocat* or volunteer*).tw. /69 or 73 68 and 74
LILACS	MH phimosis MH penis MH foreskin MH circumcision, male TW penis OR pene OR pênis TW foreskin OR prepuce OR prepucio TW phimosis OR phimoses OR fimosis OR fimose TW paraphimosis OR parafimosis OR parafimose TW circumcision OR circuncision OR circuncisão 1 OR 2 OR 3 OR 4 OR 5 OR 6 OR 7 OR 8 OR 9 MH glucocorticoids MH adrenal cortex hormones MH steroids TW steroid* OR esteroide* TW corticoid* TW corticosteroid* TW glucocorticoid* TW betamethasone OR betametasona TW clobetasol TW triamcinolone OR triancinolona TW mometaso* MH Betamethasone MH Clobetasol MH Triamcinolona MH Furoato de Mometasona TW Hydrocortisone TW Triamcinolone Acetonide TW Aristocort TW Cinonide TW Flutex TW Kena TW Triac TW Triderm TW Kenacort TW Tricort TW Volon‐A TW Elocon TW Momate TW Clobex TW Cormax TW Embeline TW Temovate TW Dermovate TW Clofenazon TW Beta‐Val TW Betaderm TW Betadexamethasone TW Betnovate TW Celestone TW Celestona TW Celeston TW Cellestoderm TW Diprolene TW Diprosone TW Valisone TW Westcort TW Locoid TW Ala‐Cort TW Hytone TW Cortaid TW Cortizone TW Vanicre TW Cortifair TW Cortef TW Cortril 11 OR 12 OR 13 OR 14 OR 15 OR 16 OR 17 OR 18 OR 19 OR 20 OR 21 OR 22 OR 23 OR 24 OR 25 OR 26 OR 27 OR 28 OR 29 OR 30 OR 31 OR 32 OR 33 OR 34 OR 35 OR 36 OR 37 OR 38 OR 39 OR 40 OR 41 OR 42 OR 43 OR 44 OR 45 OR 46 OR 47 OR 48 OR 49 OR 50 OR 51 OR 52 OR 53 OR 54 OR 55 OR 56 OR 57 OR 58 OR 59 OR 60 OR 61 OR 62 OR 63 OR 64 OR 65 PT randomized controlled trial PT controlled clinical trial PT multicenter study MH randomized controlled trials as topic MH controlled clinical trials as topic MH multicenter studies as topic MH random allocation MH double‐blind method MH single‐blind method) 67 OR 68 OR 69 OR 70 OR 71 OR 72 OR 73 OR 74 OR 75 TW ensaio$ TW ensayo$ TW trial$ 77 OR 78 OR 79 81 OR 82 OR 83 OR 84 OR 85 OR 86 OR 87 OR 88 OR 89 80 AND 90 76 OR 91 TW azar TW acaso TW placebo TW control$ TW aleat$ TW random$ TW enmascarado$ TW simpleciego TW (simple$ OR single OR duplo$ OR doble$ OR double$) AND (cego OR ciego OR blind OR mask) 10 AND 66 AND 92 MH animals MH rabbits MH rats MH primates MH dogs MH cats MH swine PT in vitro 94 OR 95 OR 96 OR 97 OR 98 OR 99 OR 100 OR 101 93 NOT 102
ClinicalTrials.gov	(circumcision OR phimosis OR prepuce OR foreskin) AND (steroids OR corticoids OR corticosteroids OR glucocorticoids OR betamethasone OR triamcinolone OR mometasone OR hydrocortisone OR beclomethasone OR clobetasol)

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Appendix 2. Risk of bias assessment tool (RoB 1)

Potential source of bias	Assessment criteria
Random sequence generation Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence	Low risk of bias: random number table; computer random number generator; coin tossing; shuffling cards or envelopes; throwing dice; drawing of lots; minimization (minimization may be implemented without a random element, and this is considered to be equivalent to being random).
	High risk of bias: sequence generated by odd or even date of birth; date (or day) of admission; sequence generated by hospital or clinic record number; allocation by judgment of the clinician; by preference of the participant; based on the results of a laboratory test or a series of tests; by availability of the intervention.
	Unclear: insufficient information about the sequence generation process to permit judgment.
Allocation concealment Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment	Low risk of bias: randomization method described that would not allow investigator/participant to know or influence intervention group before eligible participant entered in the study (e.g. central allocation, including telephone, web‐based, and pharmacy‐controlled, randomization; sequentially numbered drug containers of identical appearance; sequentially numbered, opaque, sealed envelopes).
	High risk of bias: using an open random allocation schedule (e.g. a list of random numbers); assignment envelopes were used without appropriate safeguards (e.g. if envelopes were unsealed or non‐opaque or not sequentially numbered); alternation or rotation; date of birth; case record number; any other explicitly unconcealed procedure.
	Unclear: randomization stated but no information on method used is available.
Blinding of participants and personnel Performance bias due to knowledge of the allocated interventions by participants and personnel during the study	Low risk of bias: no blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding; blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken.
	High risk of bias: no blinding or incomplete blinding, and the outcome is likely to be influenced by lack of blinding; blinding of key study participants and personnel attempted, but likely that the blinding could have been broken, and the outcome is likely to be influenced by lack of blinding.
	Unclear: insufficient information to permit judgment.
Blinding of outcome assessment Detection bias due to knowledge of the allocated interventions by outcome assessors.	Low risk of bias: no blinding of outcome assessment, but the review authors judge that the outcome measurement is not likely to be influenced by lack of blinding; blinding of outcome assessment ensured, and unlikely that the blinding could have been broken.
	High risk of bias: no blinding of outcome assessment, and the outcome measurement is likely to be influenced by lack of blinding; blinding of outcome assessment, but likely that the blinding could have been broken, and the outcome measurement is likely to be influenced by lack of blinding.
	Unclear: insufficient information to permit judgment.
Incomplete outcome data Attrition bias due to amount, nature or handling of incomplete outcome data.	Low risk of bias: no missing outcome data; reasons for missing outcome data unlikely to be related to true outcome (for survival data, censoring unlikely to be introducing bias); missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups; for dichotomous outcome data, the proportion of missing outcomes compared with observed event risk not enough to have a clinically relevant impact on the intervention effect estimate; for continuous outcome data, plausible effect size (difference in means or standardized difference in means) among missing outcomes not enough to have a clinically relevant impact on observed effect size; missing data have been imputed using appropriate methods.
	High risk of bias: reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing data across intervention groups; for dichotomous outcome data, the proportion of missing outcomes compared with observed event risk enough to induce clinically relevant bias in intervention effect estimate; for continuous outcome data, plausible effect size (difference in means or standardized difference in means) among missing outcomes enough to induce clinically relevant bias in observed effect size; 'as‐treated' analysis done with substantial departure of the intervention received from that assigned at randomization; potentially inappropriate application of simple imputation.
	Unclear: insufficient information to permit judgement
Selective reporting Reporting bias due to selective outcome reporting	Low risk of bias: the study protocol is available and all of the study's prespecified (primary and secondary) outcomes that are of interest in the review have been reported in the prespecified way; the study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were prespecified (convincing text of this nature may be uncommon).
	High risk of bias: not all of the study's prespecified primary outcomes have been reported; one or more primary outcomes is reported using measurements, analysis methods or subsets of the data (e.g. subscales) that were not prespecified; one or more reported primary outcomes were not prespecified (unless clear justification for their reporting is provided, such as an unexpected adverse effect); one or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta‐analysis; the study report fails to include results for a key outcome that would be expected to have been reported for such a study.
	Unclear: insufficient information to permit judgement
Other bias Bias due to problems not covered elsewhere in the table	Low risk of bias: the study appears to be free of other sources of bias.
	High risk of bias: had a potential source of bias related to the specific study design used; stopped early due to some data‐dependent process (including a formal‐stopping rule); had extreme baseline imbalance; has been claimed to have been fraudulent; had some other problem.
	Unclear: insufficient information to assess whether an important risk of bias exists; insufficient rationale or evidence that an identified problem will introduce bias.

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Data and analyses

Comparison 1. Topical corticosteroids versus placebo or no treatment.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Complete resolution of phimosis	10	834	Risk Ratio (M‐H, Random, 95% CI)	2.73 [1.79, 4.16]
1.2 Partial resolution of phimosis	7	745	Risk Ratio (M‐H, Random, 95% CI)	1.68 [1.17, 2.40]
1.3 Change in retractability score	2	177	Std. Mean Difference (IV, Random, 95% CI)	‐1.48 [‐2.93, ‐0.03]
1.4 Long‐term complete resolution of phimosis	2	280	Risk Ratio (M‐H, Random, 95% CI)	4.09 [2.80, 5.97]
1.5 Adverse effects (any)	11	1091	Risk Ratio (M‐H, Random, 95% CI)	0.28 [0.03, 2.62]
1.6 Complete resolution of phimosis (subgroup analysis based on age)	10	834	Risk Ratio (M‐H, Random, 95% CI)	2.73 [1.79, 4.16]
1.6.1 < 3 years of age	2	120	Risk Ratio (M‐H, Random, 95% CI)	6.27 [2.63, 14.94]
1.6.2 ≥ 3 years of age	8	714	Risk Ratio (M‐H, Random, 95% CI)	2.32 [1.55, 3.47]
1.7 Complete resolution of phimosis (subgroup analysis based on duration of treatment)	10	834	Risk Ratio (M‐H, Random, 95% CI)	2.73 [1.79, 4.16]
1.7.1 4 weeks' treatment	4	386	Risk Ratio (M‐H, Random, 95% CI)	4.80 [1.38, 16.66]
1.7.2 6–8 weeks' treatment	6	448	Risk Ratio (M‐H, Random, 95% CI)	1.92 [1.35, 2.73]
1.8 Complete resolution of phimosis (subgroup analysis based on potency of corticosteroid)	10	834	Risk Ratio (M‐H, Random, 95% CI)	2.73 [1.79, 4.16]
1.8.1 High‐potency corticosteroid	5	459	Risk Ratio (M‐H, Random, 95% CI)	2.67 [1.37, 5.19]
1.8.2 Medium‐potency corticosteroid	3	264	Risk Ratio (M‐H, Random, 95% CI)	2.49 [1.21, 5.11]
1.8.3 Low‐potency corticosteroid	2	111	Risk Ratio (M‐H, Random, 95% CI)	8.17 [2.00, 33.40]

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Characteristics of studies

Characteristics of included studies [ordered by study ID]

Balamtekin 2006.

*Study characteristics*
Methods	Study design: parallel superiority RCT Randomization ratio: not reported Study duration: January 2003–September 2004 Study follow‐up: 6 weeks Country: Turkey Setting: outpatients/Pediatric Clinic Özel Şelale and Urology Clinic Military Hospital of Kayseri
Participants	Inclusion criteria: boys aged 2–8 years with difficulties urinating, forced urination, short urinary stream, preputial ballooning, and phimosis grades 3/4/5 on Kikiros retractability scale Exclusion criteria: not reported Diagnostic criteria: Severity of phimosis using Kikiros grading of preputial retraction Grade 0: complete retraction Grade 1: complete retraction with minimal narrowing behind glans Grade 2: partial retraction, half of glans visualized Grade 3: partial retraction, only urethral meatus exposed Grade 4: minimal retraction, urethral meatus not visible Grade 5: no retraction All randomized participants (n = 53) Age: range 2–8 years Severity of phimosis: grades 3–5 Treatment group (n = 36) Age: mean 4.1 years (range 2–8 years) Severity of phimosis: not reported Control group (n = 17) Age: mean 4.7 years (range 3–7 years) Severity of phimosis: not reported
Interventions	Number of study centers: 2 Run‐in period: no Treatment group Beclomethasone dipropionate 0.05% Frequency: twice daily Duration: 6 weeks Control group Manual retraction and hygiene Co‐interventions Preputial retraction in both groups
Outcomes	Primary outcome Complete resolution of phimosis: complete retraction of prepuce, Kikiros Grade 0 Composite outcome reported: no How measured: clinical examination, retractability of prepuce by the same doctor Time points measured: 6 weeks Time points reported: 6 weeks Subgroups: none reported Secondary outcomes Partial resolution of phimosis: partial response, Kikiros Grade 1 or 2 Composite outcome reported: no How measured: clinical examination, retractability of prepuce by the same doctor Time points measured: 6 weeks Time points reported: 6 weeks Subgroups: none reported Change in retractability score: not reported Long‐term complete resolution: not reported Adverse effects: not defined Composite outcome reported: no How measured: not reported. Time points measured: 6 weeks Time points reported: 6 weeks Subgroups: none reported
Funding Sources	Not available
Declarations of interest	Not available
Notes	Language of publication: Turkish, translated Contact with study authors for additional information: no
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from publication: "participants were randomly assigned to a study group and a control group.'' Comment: study described as randomized, but method of randomization not reported.
Allocation concealment (selection bias)	Unclear risk	Comment: not reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote from publication: "No treatment was applied to patients in the control group. They were indicated local hygiene and preputial retraction." Comment: No placebo used in the control group, participants not blinded. Blinding of study personnel not described.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: although no placebo was used, outcome assessor could have been blinded, but this is not described.
Incomplete outcome data (attrition bias) Complete resolution of phimosis, partial resolution of phimosis, change in retractability score	Low risk	Comment: all randomized participants included in the analysis of these outcomes.
Incomplete outcome data (attrition bias) Adverse events	Low risk	Comment: all randomized participants included in the analysis of this outcome.
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol available to judge whether all important predefined outcomes are reported.
Other bias	Low risk	Comment: the study appears to be free of other sources of bias.

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Chao 2006.

*Study characteristics*
Methods	Study design: parallel superiority RCT Randomization ratio: not reported Study duration: not reported Study follow‐up: 25 weeks Country: China Setting: not reported
Participants	Inclusion criteria: boys aged 3–17 years with phimosis > Kikiros grade 2 Exclusion criteria: not reported Diagnostic criteria: Kikiros retractability scale All randomized participants (n = 300) Age: mean 6.88 years (groups were matched) Severity of phimosis: > Kikiros grade 2 Treatment group (n = 149) Age: not reported Severity of phimosis: mean Kikiros grade 3.68 Control group (n=151) Age: not reported. Severity of phimosis: mean Kikiros grade 3.73
Interventions	Number of study centers: not reported Run‐in period: no Treatment group Betamethasone 0.1% Frequency: twice daily Duration: 8 weeks Control group Aqueous cream Frequency: twice daily Duration: 4 weeks Betamethasone 0.1% Frequency: twice daily Duration: from week 5 for 4 weeks Co‐interventions Preputial retraction in all groups
Outcomes	Primary outcome Complete resolution of phimosis: success rate Composite outcome reported: downgrading of Kikiros score How measured: Kikiros grading score Time points measured: weeks 5 and 9 Time points reported: weeks 5 and 9 Subgroups: none reported Secondary outcomes Partial resolution of phimosis: success rate Composite outcome reported: downgrading of Kikiros score How measured: Kikiros grading score Time points measured: weeks 5 and 9 Time points reported: weeks 5 and 9 Subgroup: none reported Change in retractability score: improvement in Kikiros grading Composite outcome reported: no How measured: Kikiros grading score Time points measured: weeks 5, 9, and 25 Time points reported: weeks 5, 9, and 25 Subgroup: none reported Long‐term complete resolution of phimosis: not reported. Adverse effects: treatment complication, not defined Composite outcome reported: no How measured: not reported Time points measured: not reported Time points reported: not reported Subgroups: not reported
Funding Sources	Not available
Declarations of interest	Not available
Notes	Conference abstract only Language of publication: English At 5th week, steroid cream was given for 4 more weeks to both groups. For analysis, only data for the first 4 weeks of blinded treatment are considered. Contact with study authors for additional information: yes.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from publication: "patients underwent double‐blind randomization..." Comment: study described as randomized, but method of randomization was not reported.
Allocation concealment (selection bias)	Unclear risk	Comment: not reported.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote from publication: "patients underwent double‐blind randomization..." Comment: study described as double‐blind, a placebo was used, but it is unclear who was blinded.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote from publication: "patients underwent double‐blind randomization..." Comment: study described as double‐blind, a placebo was used, but it is unclear if the outcome assessor was blinded.
Incomplete outcome data (attrition bias) Complete resolution of phimosis, partial resolution of phimosis, change in retractability score	Unclear risk	Comment: 20/149 (13.4%) randomized participants from the treatment group and 23/151 (15.2%) randomized participants from the control group were not included in the analysis. Reasons for missing data were not described. We considered that this proportion of missing data had an unclear risk of a clinically relevant effect on the outcome measure.
Incomplete outcome data (attrition bias) Adverse events	Unclear risk	Comment: 20/149 (13.4%) randomized participants from the treatment group and 23/151 (15.2%) randomized participants from the control group were not included in the analysis. Reasons for missing data were not described. We considered that this proportion of missing data had an unclear risk of a clinically relevant effect on the outcome measure.
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol available to judge whether the study reported all important predefined outcomes.
Other bias	Low risk	Comment: study appears to be free of other sources of bias.

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Diaz Berrocal 2006.

*Study characteristics*
Methods	Study design: parallel superiority RCT Randomization ratio: not reported Study duration: not reported Study follow‐up: 8 weeks Country: Colombia Setting: outpatients/Colsubsidio Infantil Clinic, San Ignacio University Hospital and San Rafael University Clinic Hospital, Bogotá
Participants	Inclusion criteria: buys aged < 9 years with pathological phimosis and > 9 years with any type of phimosis Exclusion criteria: balanoposthitis, recurrent UTI, history of paraphimosis or other urinary tract diseases Diagnostic criteria: definition of phimosis of the Colombian Urology Society Clinical Guidelines. Pathological phimosis defined as a condition where the preputial orifice has an inflammatory aspect, whitish, indurated and the pathological examination generally demonstrates characteristics of balanitis xerotica obliterans. Physiological phimosis defined when the preputial diameter is smaller than the diameter of the glans, and does not constitute a pathological condition until puberty. All randomized participants (n = 71) Age: mean 6.02 years, median 6 years (range 1–12 years) Severity of phimosis: not reported Treatment group (n = 39) Age: not reported Severity of phimosis: not reported Control group (n = 32) Age: not reported Severity of phimosis: not reported Both groups were similar in age and severity of phimosis.
Interventions	Number of study centers: 2 Run‐in period: no Treatment group Hydrocortisone 0.5% Frequency: twice daily Duration: 4 weeks Control group Placebo cream Frequency: twice daily Duration: 4 weeks Co‐interventions None reported
Outcomes	Primary outcome: Complete resolution of phimosis: total success, without phimosis Composite outcome reported: no How measured: visual scale classification according to severity of phimosis Grade A: 90% phimosis Grade B: 50% phimosis Grade C: without phimosis Time points measured: 4 and 8 weeks Time points reported: 4 and 8 weeks Subgroup: none reported Secondary outcomes Partial resolution of phimosis: > 50% increase in preputial retractability Composite outcome reported: no How measured: visual scale classification according to severity of phimosis Grade A: 90% phimosis Grade B: 50% phimosis Grade C: without phimosis Time points measured: 4 and 8 weeks Time points reported: 4 and 8 weeks Subgroup: none reported Change in retractability score: not reported Long‐term complete resolution of phimosis: not defined Composite outcome reported: no How measured: clinical examination Time points measured: 8 weeks Time points reported: 8 weeks Subgroups: none reported Adverse effects: skin atrophy, telangiectasis, eczema, others Composite outcome reported: no How measured: clinical examination Time points measured: 4 and 8 weeks Time points reported: 4 and 8 weeks Subgroups: none reported
Funding Sources	Not available
Declarations of interest	Not available
Notes	Language of publication: Spanish Contact with study authors for additional information: no
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: "patients were distributed into one of the study groups according to a random numbers table." Comment: randomization method clearly described.
Allocation concealment (selection bias)	Unclear risk	Comment: not reported.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote from publication: "Double‐blind randomized clinical trial." Comment: study described as double‐blind, a placebo was used, but it is unclear who was blinded.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote from publication: "Double‐blind randomized clinical trial" Comment: study described as double‐blind, a placebo was used, but it is unclear if the outcome assessor was blinded.
Incomplete outcome data (attrition bias) Complete resolution of phimosis, partial resolution of phimosis, change in retractability score	Low risk	Comment: 6/77 (7.8%) randomized participants were excluded from the analysis because they had only one control; unclear which group these participants belonged to. We considered that < 10% missing data from the analysis is insufficient to have a clinically relevant effect on the outcome measure.
Incomplete outcome data (attrition bias) Adverse events	Low risk	Comment: 6/77 (7.8%) randomized participants were excluded from the analysis because they had only one control; unclear which group these participants belonged to. We considered that < 10% missing data from the analysis is insufficient to have a clinically relevant effect on the outcome measure.
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol available to judge whether the study reported all important predefined outcomes.
Other bias	Low risk	Comment: study appears to be free of other sources of bias.

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Esposito 2008.

*Study characteristics*
Methods	Study design: parallel superiority RCT Randomization ratio: 1:1 Study duration: June 2003–May 2005 Study follow‐up: median 20 months (range 6–30 months) Country: Italy Setting: outpatients
Participants	Inclusion criteria: boys aged 36 months–13 years with phimosis grade III–V Exclusion criteria: partial exposure of the glans, previous operation of the penis, prior use of steroid treatment for the same pathology, recurrent episodes of balanoposthitis Diagnostic criteria: grading of phimosis by evaluating the shape of preputium during urination Grade 0: full retraction Grade I: incomplete exposure of the glans due to preputial adherences to the coronal sulcus Grade II: exposure of half the glans Grade III: exposure of the urethral meatus Grade IV: slight retraction without exposure of the glans Grade V: no foreskin retraction All randomized participants (n = 240) Age: median 4.7 years (ranged 36 months–13 years) Severity of phimosis: 86 grade V 79 grade IV 75 grade III Treatment group (n = 120) Age: median 4.9 years Severity of phimosis: 50 grade V 33 grade IV 37 grade III Control group (n = 120) Age: median 4.6 years Severity of phimosis: 36 grade V 46 grade IV 38 grade III
Interventions	Number of study centers: 1 Run‐in period: no Treatment group Mometasone furoate 0.1% Frequency: twice daily Duration: 4 weeks Control group Placebo cream Frequency: twice daily Duration: 4 weeks Co‐interventions None reported
Outcomes	Primary outcome Complete resolution of phimosis: treatment considered successful when full retraction of the prepuce was achieved: Not reported at the end of treatment. Secondary outcomes Partial resolution of phimosis: not reported Change in retractability score: not reported Long‐term complete resolution of phimosis: Composite outcome reported: no How measured: grading of phimosis evaluated by 2 pediatric surgeons Time points measured: median follow‐up of 20 months (range 6–30 months) Time points reported: median follow‐up of 20 months (range 6–30 months) Subgroups: results according to grade of phimosis at entry Adverse effects: any untoward effects of the drugs Composite outcome reported: no How measured: not reported Time points measured: median follow‐up of 20 months (range 6–30 months) Time points reported: median follow‐up of 20 months (range 6–30 months) Subgroups: none reported
Funding Sources	Not available
Declarations of interest	Not available
Notes	Language of publication: English Contact with study authors for additional information: no
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: "A total of 240 patients with phimosis were divided into 8 groups of 30 patients each. Using a computer randomized choice the two types of medical treatment were matched with the eight groups: four groups (for a total of 120 boys) was given a placebo cream; the other four groups (also comprising 120 boys) was given steroid cream therapy." Comment: randomization method clearly described.
Allocation concealment (selection bias)	Unclear risk	Comment: Not reported.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote from publication: "120 boys were given a placebo cream therapy twice a day for 4 weeks." Comment: placebo used, but unclear who was blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote from publication: "The results were evaluated by two pediatric surgeons unaware of the type of treatment the patients had undergone." Comment: blinding of outcome assessors clearly reported.
Incomplete outcome data (attrition bias): Long‐term complete resolution of phimosis	Low risk	Quote from publication: “All the patients in our series completed the two treatment periods without interruption.” Comment: all randomized participants were included in the analysis of this outcome.
Incomplete outcome data (attrition bias) Adverse events	Low risk	Quote from publication: “All the patients in our series completed the two treatment periods without interruption.” Comment: all randomized participants included in the analysis of this outcome.
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol available to judge whether the study reported all important predefined outcomes.
Other bias	Low risk	Comment: study appears to be free of other sources of bias.

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Golubovic 1996.

*Study characteristics*
Methods	Study design: parallel superiority RCT Randomization ratio: not reported Study duration: October 1994–October 1995 Study follow‐up: mean 10.5 months (range 6 to 18 months) Country: Yugoslavia Setting: outpatients
Participants	Inclusion criteria: boys aged 3–6 years with phimosis, defined as an un‐retractable foreskin with no adhesions but a circular band of constriction making complete retraction impossible Exclusion criteria: not reported Diagnostic criteria: clinical examination, no grading scale used All randomized participants (n = 40) Age: mean 4.1 years (range 3 to 6 years) Severity of phimosis: not reported Treatment group (n = 20) Age: not reported Severity of phimosis: not reported Control group (n = 20) Age: not reported Severity of phimosis: not reported
Interventions	Number of study centers: 1 Run‐in period: no Treatment group Betamethasone 0.05% Frequency: twice daily Duration: 4 weeks Control group Neutral cream (petroleum jelly) Frequency: twice daily Duration: 4 weeks Co‐interventions Preputial retraction in both groups
Outcomes	Primary outcome Complete resolution of phimosis: foreskin fully retractable: not reported Secondary outcomes Partial resolution of phimosis: not reported Change in retractability score: not reported Long‐term complete resolution of phimosis: Composite outcome reported: no How measured: not reported Time points measured: mean follow‐up 10.5 months (range 6 to 18 months) Time points reported: mean follow‐up 10.5 months (range 6 to 18 months) Subgroups: none reported Adverse effects: local and systemic side effects, not defined Composite outcome reported: no How measured: not reported Time points measured: mean follow‐up 10.5 months (range 6 to 18 months) Time points reported: mean follow‐up 10.5 months (range 6 to 18 months) Subgroups: none reported Adverse effects: cortisol levels during treatment Composite outcome reported: no How measured: bloodspot test (Soft Touch. Boehringer, Mannheim. Germany) 1 hour after morning application of cream Time points measured: 1, 14, and 28 days after start of treatment Time points reported: mean (SD) of all 3 time points measured Subgroups: none reported
Funding Sources	Not available
Declarations of interest	Not available
Notes	Language of publication: English Contact with study authors for additional information: no
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from publication: "Two groups of 20 boys each were prospectively assessed in a double‐blind, randomized trial." Comment: study described as randomized, but method of randomization not reported.
Allocation concealment (selection bias)	Unclear risk	Comment: not reported.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote from publication: "Two groups of 20 boys each were prospectively assessed in a double‐blind, randomized trial." Comment: study described as double‐blind, placebo used, but unclear who was blinded.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote from publication: "Two groups of 20 boys each were prospectively assessed in a double‐blind, randomized trial." Comment: study described as double‐blind, placebo used, but unclear if the outcome assessor was blinded.
Incomplete outcome data (attrition bias): Long‐term complete resolution of phimosis	Low risk	Comment: all randomized participants are included in the analysis.
Incomplete outcome data (attrition bias) Adverse events	Low risk	Comment: all randomized participants included in the analysis.
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol available to judge whether the study reported all important predefined outcomes.
Other bias	Low risk	Comment: study appears to be free of other sources of bias.

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Kiss 2001.

*Study characteristics*
Methods	Study design: parallel superiority RCT Randomization ratio: not reported Study duration: not reported Study follow‐up: 5 weeks Country: Hungary Setting: outpatients
Participants	Inclusion criteria: boys aged 5–15 years with balanitis xerotica obliterans diagnosed clinically by typical macroscopic findings Exclusion criteria: not reported Diagnostic criteria: phimosis classified according to the scale of Meuli et al: Grade 1: complete preputial retractability with a sclerotic whitish ring at the tip Grade 2: partial retractability with partial exposure of the glans Grade 3: partial retractability with exposure of the meatus only Grade 4: no retractability All randomized participants (n = 40) Age: mean 8.9 years (range 5 to 15 years) Severity of phimosis: not reported Treatment group (n = 17) Age: not reported Severity of phimosis: mean 3.35 (SD0.18) points Control group (n = 16) Age: not reported Severity of phimosis: mean 3.00 (SD 0.20) points
Interventions	Number of study centers: 1 Run‐in period: no Treatment group Mometasone furoate 0.05% Frequency: once daily Duration: 5 weeks Control group Placebo ointment Frequency: once daily Duration: 5 weeks Co‐interventions None reported
Outcomes	Primary outcome: Complete resolution of phimosis: not reported Secondary outcomes Partial resolution of phimosis: not reported Change in retractability score: scale of Meuli et al Composite outcome reported: no How measured: clinical examination Time points measured: 5 weeks Time points reported: 5 weeks Subgroups: no Long‐term complete resolution of phimosis: not reported Adverse effects: defined as local or systemic Composite outcome reported: no How measured: not reported Time points measured: 5 weeks Time points reported: 5 weeks Subgroups: no
Funding Sources	Not available
Declarations of interest	Not available
Notes	Language of publication: English All participants had circumcision at the end of treatment Contact with study authors for additional information: no
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from publication: "Patients were randomized to receive steroid or placebo." Comment: study described as randomized, but method of randomization not reported.
Allocation concealment (selection bias)	Unclear risk	Comment: Not reported.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote from publication: "Our double‐blind, placebo controlled, randomized study..." Comment: study described as double‐blind, placebo used, but unclear who was blinded.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote from publication: "Our double‐blind, placebo controlled, randomized study... " Comment: study described as double‐blind, placebo used, but unclear if the outcome assessor was blinded.
Incomplete outcome data (attrition bias) Complete resolution of phimosis, partial resolution of phimosis, change in retractability score	High risk	Quote from publication: "In the steroid and placebo group 3 and 4 boys were withdrawn from the study, including 4 lost to follow‐up and 3 in whom clinically suspected balanitis xerotica obliterans was not confirmed by histological evaluations" Comment: 3/20 (15%) randomized participants from the treatment group and 4/20 (20%) randomized participants from the control group were not included in the analysis. We considered that up to 20% missing data had a high risk of a clinically relevant effect on the outcome measure.
Incomplete outcome data (attrition bias) Adverse events	Unclear risk	Quote from publication: "No local or systemic side effects occurred during the study"; "In the steroid and placebo group 3 and 4 boys were withdrawn from the study, including 4 lost to follow‐up and 3 in whom clinically suspected balanitis xerotica obliterans was not confirmed by histological evaluations." Comment: unclear if the boys lost to follow‐up and those in whom balanitis xerotica was not confirmed by histology were included when the authors say that no side effects occurred during the study.
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol available to judge whether the study reported all important predefined outcomes.
Other bias	Low risk	Comment: study appears to be free of other sources of bias.

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Lee 2006.

*Study characteristics*
Methods	Study design: parallel superiority RCT Randomization ratio: not reported Study duration: August 2002–July 2003 Study follow‐up: 4 weeks Country: South Korea Setting: outpatients/Ewha Women's University Hospital
Participants	Inclusion criteria: full‐term male infants who were treated for UTI and found to have non‐retractile physiologic phimosis Exclusion criteria: not reported Diagnostic criteria: no grading scale used All randomized participants (n = 78) Age: not reported Severity of phimosis: not reported Treatment group (n = 39) Age: mean 5.2 (SD 3.24) months (range 18 days to 12 months) Severity of phimosis: not reported Control group (n = 39) Age: mean 6.1 (SD 3.55) months (range 21 days to 12 months) Severity of phimosis: not reported
Interventions	Number of study centers: 1 Run‐in period: no Treatment group Hydrocortisone butyrate 0.1% Frequency: twice daily Duration: 4 weeks Control group Petroleum jelly Frequency: twice daily Duration: 4 weeks Co‐interventions Preputial retraction in both groups
Outcomes	Primary outcome Complete resolution of phimosis: response defined as "complete" if the prepuce became almost fully retractile Composite outcome reported: no How measured: not reported Time points measured: 4 weeks Time points reported: 4 weeks Subgroups: those with and without preputial retraction Secondary outcomes Partial resolution of phimosis: response defined as "partial" if the prepuce became partially retractile with some inner preputial adhesion Composite outcome reported: no How measured: not reported Time points measured: 4 weeks Time points reported: 4 weeks Subgroups: those with and without preputial retraction Change in retractability score: not reported Long‐term complete resolution of phimosis: not reported Adverse effects: visible local side effects of steroids, such as redness, bleeding and skin atrophy, and systemic side effects such as moon face, truncal obesity, and hirsutism Composite outcome reported: no How measured: not reported Time points measured: 4 weeks Time points reported: 4 weeks Subgroups: none reported
Funding Sources	Not available
Declarations of interest	Not available
Notes	Language of publication: English A third of participants in each group did not comply with preputial retraction for cultural reasons. Results are presented as those randomized to each group, not the subgroups of those with or without retraction. Contact with study authors for additional information: no
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from publication: "Seventy‐eight full‐term male infants who were treated for UTI and found to have non‐retractile physiologic phimosis were prospectively randomized into hydrocortisone (HC) and control groups." Comment: study described as randomized, but method of randomization not reported.
Allocation concealment (selection bias)	Unclear risk	Comment: not reported.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: placebo used, but unclear who was blinded.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: placebo used, but unclear if the outcome assessor was blinded.
Incomplete outcome data (attrition bias) Complete resolution of phimosis, partial resolution of phimosis, change in retractability score	Low risk	Quote from publication: "Only one infant in each group was dropped, and 39 infants were analyzed in each group." Comment: 1/40 (2.5%) randomized participants from the treatment group and 1/40 (2.5%) randomized participants from the control group were not included in the analysis. Reasons for missing data were not reported. We considered that this proportion of missing data was insufficient to have a clinically relevant effect on the outcome measure.
Incomplete outcome data (attrition bias) Adverse events	Low risk	Quote from publication: "Only one infant in each group was dropped, and 39 infants were analyzed in each group." Comment: 1/40 (2.5%) randomized participants from the treatment group and 1/40 (2.5%) randomized participants from the control group were not included in the analysis. Reasons for missing data were not reported. We considered that this proportion of missing data was insufficient to have a clinically relevant effect on the outcome measure.
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol available to judge whether the study reported all important predefined outcomes.
Other bias	Low risk	Comment: the study appears to be free of other sources of bias.

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Letendre 2009.

*Study characteristics*
Methods	Study design: parallel superiority RCT Randomization ratio: not reported Study duration: June 2005–January 2007 Study follow‐up: 12 months, until January 2008 Country: Canada Setting: outpatients/pediatric urology consultation
Participants	Inclusion criteria: boys aged 3–12 years with grade III–VI persistent or pathological phimosis Exclusion criteria: active balanitis, balanitis xerotica obliterans, previous topical steroid treatment, paraphimosis, lichen sclerosus, hypospadias, or any known medical condition with immune system impairment Diagnostic criteria: Phimosis Grading, Modified from Kikiros et al Grade I: complete retraction Grade II: complete retraction but tight prepuce at the glans neck Grade III: > 1/3 of the glans exposed Grade IV: < 1/3 of the glans exposed Grade V: small opening of the prepuce over the glans without retraction Grade VI: no retraction All randomized participants (n = 61) Age: median 62 months (range 20–184 months) Severity of phimosis: ≥ grade III Grade III 4.3% Grade IV 15.2% Grade V 37% Grade VI 43.5% Treatment group (n = 29) Age: not reported Severity of phimosis: not reported Control group (n = 31) Age: not reported Severity of phimosis: not reported
Interventions	Number of study centers: 1 Run‐in period: no Treatment group Triamcinolone 0.1% Frequency: twice daily Duration: 8 weeks Control group Emollient cream (Aquatain) Frequency: twice daily Duration: 8 weeks Co‐interventions Preputial retraction in both groups
Outcomes	Primary outcome Complete resolution of phimosis: retractile foreskin grades I–II Composite outcome reported: no How measured: phimosis grade at the clinical examination by a pediatric urologist Time points measured: 2, 4, and 12 months Time points reported: 2, 4, and 12 months Subgroups: none reported Secondary outcomes Partial resolution of phimosis: improved grade Composite outcome reported: no How measured: phimosis grade at clinical examination by a pediatric urologist Time points measured: 2, 4, and 12 months Time points reported: 2, 4, and 12 months Subgroups: none reported Change in retractability score: not reported Long‐term complete resolution of phimosis: not reported. Adverse effects: not defined Composite outcome reported: no How measured: not reported Time points measured: 2, 4, and 12 months Time points reported: 2, 4, and 12 months Subgroups: none reported
Funding Sources	Not available
Declarations of interest	Not available
Notes	Language of publication: English After the first 8 weeks of blinded treatment, non‐responders were given local steroids in both groups. Contact with study authors for additional information: no
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from publication: "The 59 remaining patients were randomly assigned to 0.1% triamcinolone (group 2 of 29) or emollient cream (group 1 of 31)..."; "patients were randomly assigned." Comment: study described as randomized, but method of randomization not reported.
Allocation concealment (selection bias)	Unclear risk	Comment: not reported.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote from publication: "We performed a double‐blind, randomized, placebo controlled study." Comment: study described as double‐blind, placebo used, but unclear who was blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote from publication: "Phimosis grade was assessed at the initial visit and at follow‐up by one of three pediatric urologists at our center blinded to treatment arm." Comment: blinding of outcome assessors clearly specified.
Incomplete outcome data (attrition bias) Complete resolution of phimosis, partial resolution of phimosis, change in retractability score	High risk	Comment: 8/29 (27.5%) randomized participants from the treatment group and 6/31 (19.3%) randomized participants from the control group were not included in the analysis. Reasons for missing data were not reported. We considered that up to 27.5% of missing data had a high risk of a clinically relevant effect on the outcome measure.
Incomplete outcome data (attrition bias) Adverse events	High risk	Comment: 8/29 (27.5%) randomized participants from the treatment group and 6/31 (19.3%) randomized participants from the control group were not included in the analysis. Reasons for missing data were not reported. We considered that up to 27.5% of missing data had a high risk of a clinically relevant effect on the outcome measure.
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol available to judge whether the study reported all important predefined outcomes.
Other bias	Low risk	Comment: study appears to be free of other sources of bias.

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Lindhagen 1996.

*Study characteristics*
Methods	Study design: parallel superiority RCT Randomization ratio: not reported Study duration: April 1993–April 1994 Study follow‐up: 6 months Country: Sweden Setting: outpatients/Department of Surgery at the University Hospital MAS, Mälmo
Participants	Inclusion criteria: boys aged 5–12 years with phimosis defined as unretractable foreskin when no part of the glans penis could be inspected despite retraction of the prepuce to the point where it began to fissure Exclusion criteria: not reported Diagnostic criteria: no grading scale was used All randomized participants (n = 30) Age: mean 7.5 years (range 5–12 years) Severity of phimosis: no part of the glans exposed Treatment group (n=15) Age: not reported Severity of phimosis: not reported Control group (n = 15) Age: not reported Severity of phimosis: not reported
Interventions	Number of study centers: 1 Run‐in period: no Treatment group Clobetasol propionate 0.05% (Dermovate, Glaxo) Frequency: once daily Duration: 4 to 8 weeks Control group Placebo ointment Frequency: once daily Duration: 4 to 8 weeks Co‐interventions Preputial retraction in both groups
Outcomes	Primary outcome Complete resolution of phimosis: foreskin could be retracted completely Composite outcome reported: no How measured: clinical examination Time points measured: 4 weeks, 8 weeks, and 6 months Time points reported: 4 weeks, 8 weeks, and 6 months Subgroups: none reported Secondary outcomes Partial resolution of phimosis: not reported Change in retractability score: not reported Long‐term complete resolution of phimosis: not reported Adverse effects: not defined Composite outcome reported: no How measured: not reported Time points measured: not reported Time points reported: not reported Subgroups: not reported
Funding Sources	Not available
Declarations of interest	Not available
Notes	Language of publication: English After 8 weeks of treatment, non‐responders were given steroids in both groups Contact with study authors for additional information: no
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from publication: "The patients were randomized to receive a tube of ointment with or without clobetasol propionate 0.05%." Comment: study described as randomized, but method of randomization not reported.
Allocation concealment (selection bias)	Low risk	Quote from publication: "The randomization code was broken after all patients had completed the follow‐up examination." Comment: method of allocation concealment clearly described.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote from publication: "...consecutive randomized double‐blind study."; "The randomization code was broken after all patients had completed the follow‐up examination." Comment: described as double‐blind, placebo used, randomization code unbroken until end of study. Method for blinding all participants clearly described.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote from publication: "...consecutive randomized double‐blind study."; "The randomization code was broken after all patients had completed the follow‐up examination." Comment: described as double‐blind, placebo used, randomization code unbroken until end of study. Method for blinding outcome assessor clearly described.
Incomplete outcome data (attrition bias) Complete resolution of phimosis, partial resolution of phimosis, change in retractability score	Unclear risk	Quote from publication: "One patient in each treatment group withdrew from the study for reasons unrelated to the disorder or the treatment. One patient in the clobetasol propionate group came to the first follow‐up visit having improved but could not be reached for further follow‐up examination." Comment: 2/15 (13.3%) randomized participants from the treatment group and 1/15 (6.7%) randomized participants from the control group were not included in the analysis. We considered that up to 13.3% of missing data had an unclear risk of a clinically relevant effect on the outcome measure.
Incomplete outcome data (attrition bias) Adverse events	Unclear risk	Comment: 2/15 (13.3%) randomized participants from the treatment group and 1/15 (6.7%) randomized participants from the control group were not included in the analysis. We considered that up to 13.3% of missing data had an unclear risk of a clinically relevant effect on the outcome measure.
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol available to judge whether the study reported all important predefined outcomes.
Other bias	Low risk	Comment: study appears to be free of other sources of bias.

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Lund 2005.

*Study characteristics*
Methods	Study design: parallel superiority RCT Randomization ratio: not reported Study duration: not reported Study follow‐up: 8 weeks Country: China Setting: outpatients/Pediatric Surgical Department, Prince of Wales University Hospital, Hong Kong
Participants	Inclusion criteria: boys with grade 4–6 phimosis who were on the waiting list for circumcision Exclusion criteria: not reported Diagnostic criteria: grading of phimosis Grade 1: full retraction Grade 2: full retraction of foreskin; tight behind the glans Grade 3: partial exposure of glans (>1/3) Grade 4: partial exposure of glans (< 1/3) Grade 5: partial retraction; pinhole opening of prepuce Grade 6: absolutely no retraction All randomized participants (n = 137) Age: mean 6.7 years (range 3–15 years) Severity of phimosis: grades 4, 5, and 6 Treatment group (n = 66) Age: mean 6.9 years (range 3–15 years) Severity of phimosis: not reported Control group (n = 71) Age: mean 6.7 years (range 3–14 years) Severity of phimosis: not reported
Interventions	Number of study centers: 1 Run‐in period: no Treatment group Betamethasone 0.1% (Betnovate cream, Glaxo). Frequency: twice daily Duration: 4 weeks Control group Aqueous cream Frequency: twice daily Duration: 4 weeks Co‐interventions Preputial retraction in both groups
Outcomes	Primary outcome Complete resolution of phimosis: retractile foreskin, grade ≤ 3 Composite outcome reported: no How measured: grading of phimosis at clinical examination by the same doctor Time points measured: 4 and 8 weeks Time points reported: 4 and 8 weeks Subgroups: according to grade of phimosis at entry Secondary outcomes Partial resolution of phimosis: not reported Change in retractability score: grade of retraction of the foreskin Composite outcome reported: no How measured: grading of phimosis at clinical examination by the same doctor Time points measured: 4 and 8 weeks Time points reported: 4 weeks Subgroups: none reported Long‐term complete resolution of phimosis: not reported Adverse effects: local or systemic side effects, not defined Composite outcome reported: no How measured: not reported Time points measured: during or after treatment Time points reported: during or after treatment Subgroups: none reported
Funding Sources	Not available
Declarations of interest	Not available
Notes	Language of publication: English The boys in both groups who were not cured after 4 weeks were offered a further 4 weeks of steroid treatment Contact with study authors for additional information: no
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from publication: "The boys were randomized to receive a tube of cream with or without betamethasone 0.1%." Comment: study described as randomized, but randomization method not reported.
Allocation concealment (selection bias)	Unclear risk	Comment: not reported
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote from publication: "The study, which was prospective, randomized and double‐blind..." Comment: study described as double‐blind, placebo used, but unclear who was blinded.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote from publication: "The study, which was prospective, randomized and double‐blind..." Comment: study described as double‐blind, placebo used, but unclear if the outcome assessor was blinded.
Incomplete outcome data (attrition bias) Complete resolution of phimosis, partial resolution of phimosis, change in retractability score	Low risk	Quote from publication: "All patients completed the treatment and attended the follow‐up examinations at 4 and 8 weeks." Comment: all randomized participants included in the analysis of these outcomes.
Incomplete outcome data (attrition bias) Adverse events	Low risk	Quote from publication: "All patients completed the treatment and attended the follow‐up examinations at 4 and 8 weeks." Comment: all randomized participants included in the analysis of this outcome.
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol available to judge whether the study reported all important predefined outcomes.
Other bias	Low risk	Comment: study appears to be free of other sources of bias.

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Nascimento 2011.

*Study characteristics*
Methods	Study design: parallel superiority RCT Randomization ratio: 1:1:1:1 Study duration: August 2006–November 2007 Study follow‐up: 240 days Country: Brazil Setting: outpatient/urology clinic
Participants	Inclusion criteria: boys aged 3–10 years, referred from primary care facilities to the clinic with clinical diagnosis of phimosis Exclusion criteria: previous treatment; signs of current balanitis or balanitis xerotica obliterans (foreskin or meatus stenosis, hypochromia, foreskin inflammatory process); recurrent UTI; non‐agreement with any of the Informed consent terms or non‐compliance with treatment procedures. Diagnostic criteria: Kayaba's classification of phimosis Type I: no retraction of prepuce at all Type II: external urethral meatus exposure only Type III: glans exposure halfway to sulcus of corona Type IV: glans exposure to above corona at site of preputial adhesion Type V: easy exposure of whole glans All randomized participants (n = 220) Age: mean 5.1 years (SD 2.02) and median 5.0 years Severity of phimosis: Type I 58.2% Type II 18.6% Type III 21.4% Type IV 1.8% Treatment group 1 (initial number not reported) Age: not reported Severity of phimosis: not reported Treatment group 2 (initial number not reported) Age: not reported Severity of phimosis: not reported Treatment group 3 (initial number not reported) Age: not reported Severity of phimosis: not reported Control group (initial number not reported) Age: not reported Severity of phimosis: not reported No difference was observed among the 4 study arms regarding mean age (P = 0.088) or phimosis type (P = 0.88).
Interventions	Number of study centers: 1 Run‐in period: no Treatment group 1 Betamethasone valerate 0.2% + hyaluronidase Frequency: twice daily Duration: 60 days Treatment group 2 Betamethasone valerate 0.2% Frequency: twice daily Duration: 60 days Treatment group 3 Betamethasone valerate 0.1% Frequency: twice daily Duration: 60 days Control group Placebo Frequency: twice daily Duration: 60 days Co‐interventions Preputial retraction in all groups
Outcomes	Primary outcome Complete resolution of phimosis: cure (success) defined as complete, easy foreskin retraction with total exposure of the glans Composite outcome reported: no How measured: Kayaba's classification at clinical examination by same pediatric urologist Time points measured: 60 days Time points reported: 60 days Subgroups: according to initial type of phimosis Secondary outcomes Partial resolution of phimosis: partial response defined as improved grade of phimosis Composite outcome reported: no How measured: Kayaba's Classification at clinical examination by same pediatric urologist Time points measured: 60 days Time points reported: 60 days Subgroups: according to initial type of phimosis Change in retractability score: not reported Long‐term complete resolution of phimosis: not reported Adverse effects: not defined Composite outcome reported: no How measured: not reported Time points measured: 30, 60, and 240 days Time points reported: not specified Subgroups: no
Funding Sources	Not available
Declarations of interest	None declared
Notes	Language of publication: English Treatment group 1 was not considered in our analysis. Contact with study authors for additional information: no
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: "Patients were randomized to one of the four groups of intervention according to a computer‐generated random choice determined by a research assistant." Comment: randomization method clearly reported.
Allocation concealment (selection bias)	Unclear risk	Comment: not reported.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote from publication: "...our prospective double‐blinded study."; "The formulations were specifically designed for the study by the same pharmacy." Comment: study described as double‐blind, placebo used, but unclear who was blinded.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote from publication: "...our prospective double‐blinded study." Comment: study described as double‐blind, placebo used, but unclear if the outcome assessor was blinded.
Incomplete outcome data (attrition bias) Complete resolution of phimosis, partial resolution of phimosis, change in retractability score	Unclear risk	Quote from publication: "Two hundred twenty patients were enrolled, of whom 195 were included at our final analysis. Eleven patients (5%) were excluded due to noncompliance with the application of the ointment and 16 patients (7.3%) were lost to the follow‐up but were considered in the analysis before they dropped out. Exclusion and drop‐out rates were no different among the four groups of treatment." Comment: 25/220 (11.4%) randomized participants not included in the analysis (no indication of treatment group). We considered that 11.4% of missing data had an unclear risk of a clinically relevant effect on the outcome measure.
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol available to judge whether the study reported all important predefined outcomes.
Other bias	Low risk	Comment: study appears to be free of other sources of bias.

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Pileggi 2007.

*Study characteristics*
Methods	Study design: parallel superiority RCT Randomization ratio: not reported Study duration: not reported Study follow‐up: 8 weeks Country: Brazil Setting: outpatients/urology clinic
Participants	Inclusion criteria: boys aged 2–13 years with symptomatic phimosis and referred to surgery, presenting with grade 5 phimosis Exclusion criteria: not reported Diagnostic criteria: Kikiros, Beasley, and Woodward phimosis classification of foreskin retractability Grade 0: full retraction, not tight behind glans, or easy retraction limited only by congenital adhesions to the glans Grade 1: full retraction of foreskin, tight behind the glans Grade 2: partial exposure of glans, prepuce (not congenital adhesions) limiting factor Grade 3: partial retraction, the meatus just visible Grade 4: slight retraction, but some distance remains between tip and glans, that is, neither meatus nor glans can be exposed Grade 5: absolutely no retraction is possible All randomized participants (n = 130) Age: mean 4.6 years Severity of phimosis: Kikiros grade 5 Treatment group: (initial number not reported) Age: not clearly reported Severity of phimosis: not reported Control group: (initial number not reported) Age: not clearly reported Severity of phimosis: not reported Children's age distribution was similar, with ages ≤ 5 years predominating in both groups. The phimotic ring diameter ranged from a pinhole to 2.0 cm, with a similar distribution in both groups.
Interventions	Number of study centers: 1 Run‐in period: no Treatment group Mometasone furoate 0.1% Frequency: twice daily Duration: 8 weeks Control group Moisturizing cream Frequency: twice daily Duration: 8 weeks Co‐interventions Preputial retraction in both groups
Outcomes	Primary outcome Complete resolution of phimosis: total absence of preputial ring and adhesions (Kikiros grade 1) or only preputial adhesions in the absence of ring (Kikiros grade 2) Composite outcome reported: no How measured: Kikiros grading at clinical examination by 1 of the investigators Time points measured: 8 weeks Time points reported: 8 weeks Subgroups: no Secondary outcomes Partial resolution of phimosis: not reported Change in retractability score: not reported Long‐term complete resolution of phimosis: not reported Adverse effects: not reported
Funding Sources	Not available
Declarations of interest	Not available
Notes	Language of publication: English After the initial 8 weeks blinded treatment, non‐responders from both groups were given 8 weeks of corticoid treatment. Only results from the first 8 weeks are considered. Contact with study authors for additional information: no
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from publication: "...randomized double‐blind clinical trial..." Comment: study described as randomized, but randomization method not reported.
Allocation concealment (selection bias)	Low risk	Quote from publication: "numbered cream tubes were provided."; "At the end of the study, after the second treatment, the tubes were decoded." Comment: method of allocation concealment clearly reported.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote from publication: "Topical treatment was applied twice daily for 8 weeks, on a double‐blind fashion. For this purpose, numbered cream tubes were provided. A moisturizing cream was used as placebo."; "At the end of the study, after the second treatment, the tubes were decoded." Comment: described as double‐blind, placebo used, and numbered tubes provided that were decoded only at the end of the study. Methods for blinding all participants clearly described.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote from publication: "Topical treatment was applied twice daily for 8 weeks, on a double‐blind fashion. For this purpose, numbered cream tubes were provided. A moisturizing cream was used as placebo."; "At the end of the study, after the second treatment, the tubes were decoded." Comment: described as double‐blind, placebo used, and numbered tubes provided that were decoded only at the end of the study. Methods for blinding all participants clearly described.
Incomplete outcome data (attrition bias) Complete resolution of phimosis, partial resolution of phimosis, change in retractability score	Unclear risk	Quote from publication: "Of 130 children eligible to the study, 6 could not be reassessed by the designated investigator and were excluded. Of the remaining 124 children, 7 from the placebo group and 7 from the drug group interrupted the treatment and were also excluded." Comment: 7/63 (11.1%) randomized participants from the treatment group and 7/61 (11.5%) from the control group were not included in the analysis. We considered that this proportion of missing data had an unclear risk of a clinically relevant effect on the outcome measure.
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol available to judge whether the study reported all important predefined outcomes.
Other bias	Low risk	Comment: study appears to be free of other sources of bias.

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Romero‐Cortes 2018.

*Study characteristics*
Methods	Study design: parallel superiority RCT Randomization ratio: 1:1:1 Study duration: October 2017–January 2018 Study follow‐up: 2 months Country: Mexico Setting: outpatients
Participants	Inclusion criteria: infants aged 30–60 days with physiological phimosis grades I and II according to Kayaba's Classification, born at Hospital Naval de Veracruz (HOSNAVESVER) Exclusion criteria: not reported Diagnostic criteria: Kayaba's classification of phimosis. Type I: no retraction of prepuce at all Type II: external urethral meatus exposure only Type III: glans exposure halfway to sulcus of corona Type IV: glans exposure to above corona at site of preputial adhesion Type V: easy exposure of whole glans All randomized participants (n = 61) Age: 30–60 days. Median age was similar in all groups. Severity of phimosis: Kayaba grades I and II Treatment group (n = 20) Age: 30–60 days Severity of phimosis: Kayaba grade I: 17 (85%) Control group 1 (n = 20) Age: 30–60 days Severity of phimosis: Kayaba grade I: 14 (70%) Control group 2 (n = 21) Age: 30–60 days Severity of phimosis: Kayaba grade I: 17 (81%)
Interventions	Number of study centers: 1 Run‐in period: no Treatment group: Hydrocortisone 1% Frequency: twice daily Duration: 2 months Control group 1: Petroleum jelly Frequency: twice daily Duration: 2 months Control group 2: Hydrocortisone 1% Frequency: twice daily Duration: 2 months Co‐interventions Preputial retraction in the intervention group and in control group 1.
Outcomes	Primary outcome Complete resolution of phimosis: Kayaba grade VI or V Composite outcome reported: no How measured: clinical examination Time points measured: 2 months Time points reported: 2 months Subgroups: no Secondary outcomes Partial resolution of phimosis: change by ≥ 2 Kayaba grades Composite outcome reported: no How measured: clinical examination Time points measured: 2 months Time points reported: 2 months Subgroups: no Change in retractability score: median and range before and after treatment Composite outcome reported: no How measured: clinical examination Time points measured: 2 months Time points reported: 2 months Subgroups: no Long‐term complete resolution of phimosis: not reported Adverse effects: Composite outcome reported: no How measured: clinical examination Time points measured: 2 months Time points reported: 2 months Subgroups: no
Funding Sources	Not stated
Declarations of interest	Not stated
Notes	Language of publication: Spanish Control group 2 (hydrocortisone 1% without preputial retraction) was not included in our analysis. Contact with study authors for additional information: no
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: "...assignment to study groups was done using the software EPIDAT 3.1." Comment: randomization method clearly reported.
Allocation concealment (selection bias)	Unclear risk	Comment: allocation concealment not reported.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: study used hydrocortisone and petroleum jelly, but unclear if they were presented in identical tubes or if they had identical appearance.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote from publication: "...there was blinding of the investigator that evaluated treatment response." Comment: blinding of outcome assessor was clearly reported.
Incomplete outcome data (attrition bias) Complete resolution of phimosis, partial resolution of phimosis, change in retractability score	Low risk	Comment: "Table 1. Comparison of the efficacy and security of each treatment group" shows there were 20 participants per group at the start of the study and 20 participants in each group at the end of the study for the evaluation of preputial retractability.
Incomplete outcome data (attrition bias) Adverse events	Low risk	Comment: "Table 1. Comparison of the efficacy and security of each treatment group" shows there were 20 participants per group at the start of the study and 20 participants in each group at the end of the study for the evaluation of adverse events.
Selective reporting (reporting bias)	Unclear risk	Comment: no protocol available to judge whether the study reported all important predefined outcomes.
Other bias	Low risk	Comment: study appears to be free of other sources of bias.

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Yilmaz 2003.

*Study characteristics*
Methods	Study design: parallel superiority RCT Randomization ratio: not reported Study duration: December 1999–June 2002 Study follow‐up: 2 months Country: Turkey Setting: outpatients
Participants	Inclusion criteria: boys aged 3–6 years with phimosis, defined as the narrowing of the opening of foreskin, which makes it difficult to retract the foreskin to the coronal sulcus. Exclusion criteria: not reported Diagnostic criteria: type of phimosis, classified as follows Retractable: when a tight and constricting phimotic ring existed, but did not completely prevent the retraction of the foreskin. Non‐retractable: when the ring prevented retraction of the foreskin, and the external urethral meatus was exposed. Pinpoint: when the foreskin was so constricted that the meatus could not be visualized. All randomized participants (n = 149) Age: mean 4.47 years (range 3–6 years) Severity of phimosis: Retractable: 40.3% Non‐retractable: 32.9% Pinpoint: 26.8% Treatment group 1 (n = 51) Age: not reported Severity of phimosis: Retractable: 43.1% Non‐retractable: 31.4% Pinpoint: 25.5% Treatment group 2 (n = 50) Age: mean 4.52 years Severity of phimosis: Retractable: 40% Non‐retractable: 32% Pinpoint opening: 28% Control group (n = 48) Age: mean 4.43 years Severity of phimosis: Retractable: 37.5% Non‐retractable: 35.4% Pinpoint opening: 27.1%
Interventions	Number of study centers: 1 Run‐in period: no Treatment group 1 Circumcision Treatment group 2 Betamethasone 0.05% Frequency: twice daily Duration: 1 or 2 months Control group Petroleum jelly Frequency: twice daily Duration: 1 or 2 months Co‐interventions Preputial retraction in treatment group 2 and in the control group.
Outcomes	Primary outcome Complete resolution of phimosis: success if the prepuce was retractable and was without a ring. Composite outcome reported: no How measured: clinical examination Time points measured: 1 and 2 months Time points reported: 1 and 2 months Subgroups: yes, according to initial retractability of the prepuce and by age Secondary outcomes Partial resolution of phimosis: not reported Change in retractability score: not reported Long‐term complete resolution of phimosis: not reported Adverse effects: not reported
Funding Sources	Not available
Declarations of interest	Not available
Notes	Treatment group 1 (circumcision) was not included in our analysis. Language of publication: English Contact with study authors for additional information: no
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote from publication: "Children were randomly separated into three groups." Comment: study describes that groups were randomized, but randomization method not reported.
Allocation concealment (selection bias)	Unclear risk	Comment: Not reported
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote from publication: "...group III comprised 48 children who would receive a topical placebo neutral cream." Comment: placebo used, but unclear who was blinded.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote from publication: "...group III comprised 48 children who would receive a topical placebo neutral cream." Comment: placebo used, but unclear if the outcome assessor was blinded.
Incomplete outcome data (attrition bias) Complete resolution of phimosis, partial resolution of phimosis, change in retractability score	Low risk	Quote from publication: "All patients were re‐evaluated after 1 month and again after 2 months in the steroid and placebo groups." Comment: all randomized participants included in the analysis of these outcomes.
Selective reporting (reporting bias)	Unclear risk	Quote from publication: "Control examinations were held immediately after treatment and again after 1 and 2 months." Comment: results presented only for the 1‐month and 2‐month examinations. This may introduce an uncertain risk of bias.
Other bias	Low risk	Comment: study appears to be free of other sources of bias.

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RCT: randomized controlled trial; SD: standard deviation; UTI: urinary tract infection.

Characteristics of excluded studies [ordered by study ID]

Study	Reason for exclusion
Ceballos‐Gonzalez 2006	Used an active (non‐placebo) comparison.
Chu 1999	Not an RCT.
Flatz 2015	Not an RCT.
Garcia de Freitas 2006	Used an active (non‐placebo) comparison.
Jung 2008	Not an RCT.
Kikiros 1993	Not an RCT; compared corticosteroids with a non‐placebo control.
Nobre 2010	Compared corticosteroids with surgery (circumcision).
Sookpotarom 2013	Compared 2 formulations of betamethasone.
Yang 2005	Used an active (non‐placebo) comparison.
Zampieri 2005	Not an RCT.
Zampieri 2007	Not an RCT.

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RCT: randomized controlled trial.

Characteristics of ongoing studies [ordered by study ID]

EudraCT 2006‐003779‐11.

Study name	Treatment of phimosis with topical mometasone furoate application
Methods	Randomized, double blind, placebo‐controlled trial
Participants	Boys with phimosis (aged < 18 years)
Interventions	Topical mometasone furoate application
Outcomes	Not stated
Starting date	12 July 2006
Contact information
Notes	Ongoing studies. No results yet.

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ISRCTN64387412.

Study name	Randomisation to topical corticosteroids or placebo for the treatment of the non‐retractile foreskin
Methods	RCT
Participants	Boys aged ≥ 3 years with a physiological non‐retractile foreskin
Interventions	Placebo, 1% hydrocortisone or 0.1% betnovate ointment
Outcomes	Retraction of the foreskin
Starting date	1 October 2002
Contact information	Central Manchester & Manchester Children's University Hospitals BH Booth Hall Children's Hospital Charlestown Road Blackley Manchester M9 7AA United Kingdom
Notes	30 November 2015: no publications found on PubMed.

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NCT01108198.

Study name	Treatment of phimosis with topical steroid cream‐double‐blind, randomized, placebo‐controlled study
Methods	RCT
Participants	Boys aged 6–16 years with unretractable foreskin requiring treatment
Interventions	Mometasone furoate cream
Outcomes	Retractability of foreskin
Starting date	October 2006
Contact information	Johanna Rättyä, M.D., Ph.D. +358 8 315 2011 johanna.rattya@ppshp.fi
Notes

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RCT: randomized controlled trial.

Differences between protocol and review

This is an update of a Cochrane review first published in 2014 (Moreno 2014). The first version of this review followed the methodology as described in the corresponding protocol (Moreno 2011), but added a summary of findings table and used GRADE to evaluate the certainty of the evidence.

Below we have listed the differences between the first version and this updated version of the review.

We made changes to the original search strategy to make it more comprehensive.
We added LILACS and ClinicalTrials.gov as databases for our search strategy.
We searched for relevant urologic conference proceedings through Cochrane CENTRAL in this update.
We added long‐term complete resolution of phimosis as a new secondary outcome and dropped the outcome re‐stenosis at the request of the Editorial Group, because such analysis would not have been based on prognostically comparable groups at baseline as established at the time of randomization.
We established minimum clinically important difference (MCID) values for the outcomes measured to serve as the basis of interpretation.
We used Covidence to manage articles from our searches, remove potential duplicate records, and screen titles and abstracts (Covidence).
We used RevMan Web for this update (RevMan Web 2022).

Contributions of authors

GM: background, search strategy, statistical analysis, writing the manuscript CR: selection of studies, quality assessment, data extraction JC: search strategy, selection of studies, quality assessment BP: quality assessment, data extraction TP: statistical analysis, discrepancies resolution, writing the manuscript

Sources of support

Internal sources

Family Medicine Department, School of Medicine, Pontificia Universidad Catolica de Chile, Chile

In‐kind support

External sources

National Health Research Fund (FONIS) Project SA 09120025, Chile

The National Health Research Fund is a governmental fund that finances health research in Chile to investigators from local universities or from the National Health System.

Declarations of interest

GM: none known CR: none known JC: none known BP: none known TP: none known

New search for studies and content updated (conclusions changed)

References

References to studies included in this review

Balamtekin 2006 {published data only (unpublished sought but not used)}

Balamtekin N, Uloucak N, Atay A, Aydin HI, Karabiyik I. The effect of topical corticosteroid creams on phimosis treatment. Erciyes Tip Dergisi 2006;28(3):120-4. [EMBASE: 2006527288] [Google Scholar]

Chao 2006 {published data only}

Chao SY, Liu KW, Wong MW, Leung KW, Chung KW, Kwok WK. Topical steroid therapy for phimosis: a prospective double-blind randomized study [abstract no: PS039P]. ANZ Journal of Surgery 2006;76(Suppl 1):A54. [CENTRAL: CN-00584255] [Google Scholar]

Diaz Berrocal 2006 {published data only}

Díaz Berrocal J, Pérez Niño JF, Lee J, Sierra CF. Role of the topic steroids in the management of the pathological phimosis [Papel de los esteroides tópicos en el manejo de la fimosis patológica]. Urología Colombiana 2006;15:151-7. [Google Scholar]

Esposito 2008 {published data only}

Esposito C, Centonze A, Alicchio F, Savanelli A, Settimi A. Topical steroid application versus circumcision in pediatric patients with phimosis: a prospective randomized placebo controlled clinical trial. World Journal of Urology 2008;26(2):187-90. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]

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Golubovic Z, Milanovic D, Vukadinovic V, Rakic I, Perovic S. The conservative treatment of phimosis in boys. British Journal of Urology 1996;78(5):786-8. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]

Kiss 2001 {published data only}

Kiss A, Csontai A, Pirot L, Nyirady P, Merksz M, Kiraly L. The response of balanitis xerotica obliterans to local steroid application compared with placebo in children. Journal of Urology 2001;165(1):219-20. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
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Lee 2006 {published data only}

Lee JW, Cho SJ, Park EA, Lee SJ. Topical hydrocortisone and physiotherapy for nonretractile physiologic phimosis in infants. Pediatric Nephrology 2006;21(8):1127-30. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]

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Letendre J, Barrieras D, Franc-Guimond J, Abdo A, Houle AM. Topical triamcinolone for persistent phimosis. Journal of Urology 2009;182(Suppl 4):1759-63. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]

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Lindhagen T. Topical clobetasol propionate compared with placebo in the treatment of unretractable foreskin. European Journal of Surgery 1996;162(12):969-72. [MEDLINE: ] [PubMed] [Google Scholar]

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Lund L, Wai KH, Mui LM, Yeung CK. An 18-month follow-up study after randomized treatment of phimosis in boys with topical steroid versus placebo. Scandinavian Journal of Urology and Nephrology 2005;39(1):78-81. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
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Nascimento 2011 {published data only}

Nascimento FJ, Pereira RF, Silva JL 2nd, Tavares A, Pompeo AC. Topical betamethasone and hyaluronidase in the treatment of phimosis in boys: a double-blind, randomized, placebo-controlled trial. International Brazilian Journal of Urology 2011;37(3):314-9. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]

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Pileggi F de O, Vicente YA. Phimotic ring topical corticoid cream (0.1% mometasone furoate) treatment in children. Journal of Pediatric Surgery 2007;42(10):1749-52. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]

Romero‐Cortes 2018 {published data only}

Romero-Cortes I, Leonardo-Puerta JD, Marquez-Celedonio FG. Effectiveness of the treatment with topical steroids of physiological phimosis [Efectividad del tratameinto con esteroide topico en fimosis fisiologica]. Rev Sanid Milit Mex 2018;72(5-6):300-4. [Google Scholar]

Yilmaz 2003 {published data only}

Yilmaz E, Batislam E, Basar MM, Basar H. Psychological trauma of circumcision in the phallic period could be avoided by using topical steroids. International Journal of Urology 2003;10(12):651-6. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]

References to studies excluded from this review

Ceballos‐Gonzalez 2006 {published data only}

Ceballos-Gonzalez S, Torres-Cantero C, Trujillo-Hernandez B, Muniz J, Huerta M, Trujillo X, et al. Comparative effectiveness of 0.1% methylprednisolone aceponate and 0.05% betamethasone dipropionate in children with nonretractable prepuce [Comparación de la efectividad entre la aplicación de aceponato de metilprednisolona 0.1% y dipropionato de betametasona 0.05% en niños con prepucio no retráctil]. Gaceta Medica de Mexico 2006;142(2):121-4. [EMBASE: 2008418715] [PubMed] [Google Scholar]

Chu 1999 {published data only}

Chu CC, Chen KC, Diau GY. Topical steroid treatment of phimosis in boys. Journal of Urology 1999;162(3 Pt 1):861-3. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]

Flatz 2015 {published data only}

Flatz A, Rey-Bellet Gasser C, Elm E. Phimosis: are topical corticosteroids an alternative to surgical treatment? Praxis (Bern 1994) 2015;104(13):701-2. [DOI] [PubMed] [Google Scholar]

Garcia de Freitas 2006 {published data only}

Garcia de Freitas R, Nobre YD, Demarchi GT, Hachul M, Macedo Jr A, Srougi M, et al. Topical treatment for phimosis: time span and other factors behind treatment effectiveness. Journal of Pediatric Urology 2006;2(4):380-5. [EMBASE: 2006354064] [DOI] [PubMed] [Google Scholar]

Jung 2008 {published data only}

Jung SG, Bang SI, Lee SD. Effect of topical steroids (0.05% clobetasol propionate) in children with phimosis. Korean Journal of Urology 2008;49(12):1140-3. [EMBASE: 2009015319] [DOI] [PMC free article] [PubMed] [Google Scholar]

Kikiros 1993 {published data only}

Kikiros CS, Beasley SW, Woodward AA. The response of phimosis to local steroid application. Pediatric Surgery International 1993;8(4):329-32. [EMBASE: 1993213887] [Google Scholar]

Nobre 2010 {published data only}

Nobre YD, Freitas RG, Felizardo MJ, Ortiz V, Macedo Jr A. To circ or not to circ: clinical and pharmacoeconomic outcomes of a prospective trial of topical steroid versus primary circumcision. International Brazilian Journal of Urology 2010;36(1):75-85. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]

Sookpotarom 2013 {published data only}

Sookpotarom P, Asawutmangkul C, Srinithiwat B, Leethochawalit S, Vejchapipat P. Is half strength of 0.05 % betamethasone valerate cream still effective in the treatment of phimosis in young children? Pediatric Surgery International 2013;29(4):393-6. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]

Yang 2005 {published data only}

Yang SS, Tsai YC, Wu CC, Liu SP, Wang CC. Highly potent and moderately potent topical steroids are effective in treating phimosis: a prospective randomized study. Journal of Urology 2005;173(4):1361-3. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]

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Zampieri N, Corroppolo M, Camoglio FS, Giacomello L, Ottolenghi A. Phimosis: stretching methods with or without application of topical steroids? Journal of Pediatrics 2005;147(5):705-6. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]

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References to ongoing studies

EudraCT 2006‐003779‐11 {published data only}2006‐003779‐111212

EudraCT 2006-003779-11. Treatment of phimosis with topical mometasone furoate application. www.clinicaltrialsregister.eu/ctr-search/search?query=2006-003779-11 2006.

ISRCTN64387412 {published data only}N64387412N0453141246

ISRCTN 64387412. Randomisation to topical corticosteroids or placebo for the treatment of the non-retractile foreskin. www.isrctn.com/ISRCTN64387412 (first received 9 September 2005).

NCT01108198 {published data only}

NCT01108198. Treatment of phimosis with topical steroid cream-double-blind, randomized, placebo-controlled study. clinicaltrials.gov/study/NCT01108198 (first received 20 April 2010). [NCT: 01108198]

Additional references

Berdeu 2001

Berdeu D, Sauze L, Ha-Vinh P, Blum-Boisgard C. Cost-effectiveness analysis of treatments for phimosis: a comparison of surgical and medicinal approaches and their economic effect. BJU International 2001;87(3):239-44. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]

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Study	Intervention(s)	Intervention(s) as applied in a clinical practice setting	Comparator(s)	Comparator(s) as applied in a clinical practice setting
Balamtekin 2006	I: beclomethasone dipropionate 0.05% Frequency: twice daily Duration: 6 weeks CoI: Preputial retraction.	Ointment was applied to the narrow end of the prepuce and retraction of the prepuce was indicated without forcing.	C: no placebo Frequency: not reported Duration: 6 weeks CoI: Preputial retraction.	Retraction of the prepuce was indicated without forcing.
Chao 2006	I: betamethasone 0.1% Frequency: twice daily Duration: 8 weeks CoI: Preputial retraction.	Ointment was applied with preputial retraction.	C: aqueous cream Frequency: twice daily Duration: 4 weeks (at 5th week, steroid cream was given for 4 more weeks to both groups) CoI: Preputial retraction.	Ointment was applied with preputial retraction.
Diaz Berrocal 2006	I: hydrocortisone 0.5% Frequency: twice daily Duration: 4 weeks CoI: none reported	Not reported	C: placebo cream Frequency: twice daily Duration: 4 weeks CoI: none reported	Not reported
Esposito 2008	I: mometasone furoate 0.1% Frequency: twice daily Duration: 4 weeks CoI: none reported	Not reported	C: placebo cream Frequency: twice daily Duration: 4 weeks CoI: none reported	Not reported
Golubovic 1996	I: betamethasone 0.05% Frequency: twice daily Duration: 4 weeks CoI: Preputial retraction.	A thin layer of cream was applied on the child's foreskin, from the coronal groove to the meatus. No retraction was indicated during the first 2 weeks of treatment; after this period, the foreskin was retracted gently and gradually.	C: neutral cream (petroleum jelly) Frequency: twice daily Duration: 4 weeks CoI: Preputial retraction.	A thin layer of cream was applied on the child's foreskin, from the coronal groove to the meatus. No retraction was indicated during the first 2 weeks of treatment; after this period, the foreskin was retracted gently and gradually.
Kiss 2001	I: mometasone furoate 0.05% Frequency: once daily Duration: 5 weeks. CoI: none reported	Ointment applied on the tip of the exposed prepuce during gentle retraction.	C: placebo ointment Frequency: once daily Duration: 5 weeks CoI: none reported	Ointment applied on the tip of the exposed prepuce during gentle retraction.
Lee 2006	I: hydrocortisone butyrate 0.1% Frequency: twice daily Duration: 4 weeks. CoI: Preputial retraction.	The dose of each application was just enough to make a thin film around the preputial margin. Gentle retraction of the prepuce as much as possible without causing pain was indicated before topical ointment application.	C: petroleum jelly Frequency: twice daily Duration: 4 weeks CoI: Preputial retraction.	The dose of each application was just enough to make a thin film around the preputial margin. Gentle retraction of the prepuce as much as possible without causing pain was indicated before topical ointment application.
Letendre 2009	I: triamcinolone 0.1% Frequency: twice daily Duration: 8 weeks CoI: Preputial retraction.	The cream was applied and the prepuce retracted as much as possible without discomfort.	C: emollient cream (Aquatain) Frequency: twice daily Duration: 8 weeks CoI: Preputial retraction.	The cream was applied and the prepuce retracted as much as possible without discomfort.
Lindhagen 1996	I: clobetasol propionate 0.05% (Dermovate, Glaxo) Frequency: once daily Duration: 4–8 weeks CoI: Preputial retraction.	The foreskin was retracted as much as possible without causing pain and then a thin layer of the ointment was applied and rubbed into the prepuce from the corona glandis to the distal margin.	C: placebo ointment Frequency: once daily Duration: 4–8 weeks CoI: Preputial retraction.	The foreskin was retracted as much as possible without causing pain and then a thin layer of the ointment was applied and rubbed into the prepuce from the corona glandis to the distal margin.
Lund 2005	I: betamethasone 0.1% (Betnovate cream, Glaxo) Frequency: twice daily Duration: 4 weeks CoI: Preputial retraction.	The prepuce was retracted as much as possible without causing pain or fissure and then a thin layer of the cream was applied and rubbed onto it.	C: aqueous cream Frequency: twice daily. Duration: 4 weeks CoI: Preputial retraction.	The prepuce was retracted as much as possible without causing pain or fissure and then a thin layer of the cream was applied and rubbed onto it.
Nascimento 2011	I1: betamethasone valerate 0.2% Frequency: twice daily Duration: 60 days CoI: Preputial retraction.	A small amount of ointment was applied with subtle traction on the foreskin.	C: placebo Frequency: twice daily Duration: 60 days CoI: Preputial retraction.	A small amount of ointment was applied with subtle traction on the foreskin.
Nascimento 2011	I2: betamethasone valerate 0.1% Frequency: twice daily. Duration: 60 days. CoI: Preputial retraction.	A small amount of ointment was applied with subtle traction on the foreskin.
Pileggi 2007	I: mometasone furoate 0.1% Frequency: twice daily. Duration: 8 weeks. CoI: Preputial retraction.	During the first 4 weeks, light preputial retraction was applied. During the next 4 weeks, preputial traction was increased to a moderate degree.	C: moisturizing cream Frequency: twice daily Duration: 8 weeks CoI: Preputial retraction.	During the first 4 weeks, light preputial retraction was applied. During the next 4 weeks, preputial traction was increased to a moderate degree.
Romero‐Cortes 2018	I: hydrocortisone 1% Frequency: twice daily Duration: 60 days CoI: Preputial retraction.	Cream was applied over the slightly retracted prepuce.	C: petroleum jelly Frequency: twice daily. Duration: 60 days CoI: Preputial retraction.	Cream was applied over the slightly retracted prepuce.
Yilmaz 2003	I: betamethasone 0.05% Frequency: twice daily Duration: 1 or 2 months CoI: Preputial retraction.	After 5 days of treatment, prepuces were retracted by parents each day throughout the treatment.	C: petroleum jelly Frequency: twice daily Duration: 1 or 2 months CoI: Preputial retraction.	After 5 days of treatment, prepuces were retracted by parents each day throughout the treatment.

PERMALINK

Topical corticosteroids for treating phimosis in boys

Gladys Moreno

Cristian Ramirez

Javiera Corbalán

Blanca Peñaloza

Macarena Morel Marambio

Tomas Pantoja

Abstract

Background

Objectives

Search methods

Selection criteria

Data collection and analysis

Main results

Authors' conclusions

Plain language summary

Summary of findings

Summary of findings 1. Topical corticosteroids compared to placebo or no treatment for treating phimosis in boys.

Background

Description of the condition

Description of the intervention

How the intervention might work

Why it is important to do this review

Objectives

Methods

Criteria for considering studies for this review

Types of studies

Types of participants

Types of interventions

Types of outcome measures

Primary outcomes

Secondary outcomes

Method and timing of outcome measurements

Complete resolution of phimosis

Partial resolution of phimosis

Change in retractability score

Long‐term complete resolution of phimosis

Local or systemic adverse events

Search methods for identification of studies

Electronic searches

Searching other resources

Data collection and analysis

Selection of studies

Data extraction and management

Assessment of risk of bias in included studies

Measures of treatment effect

Unit of analysis issues

Dealing with missing data

Assessment of heterogeneity

Assessment of reporting biases

Data synthesis

Subgroup analysis and investigation of heterogeneity

Sensitivity analysis

Summary of findings and assessment of the certainty of the evidence

Results

Description of studies

Results of the search

1.

Included studies

1. Baseline characteristics of included studies.

2. Description of interventions in included studies.

Excluded studies

Ongoing studies

Risk of bias in included studies

2.

3.

Allocation

Sequence generation

Allocation concealment

Blinding

Blinding of participants and personnel

Blinding of outcome assessment

Incomplete outcome data

Complete resolution of phimosis, partial resolution of phimosis, and change in retractability score

Long‐term complete resolution of phimosis

Adverse effects

Selective reporting

Other potential sources of bias

4.