Perioperative interventions in pelvic organ prolapse surgery

Nir Haya; Benjamin Feiner; Kaven Baessler; Corina Christmann‐Schmid; Christopher Maher

doi:10.1002/14651858.CD013105

. 2018 Aug 19;2018(8):CD013105. doi: 10.1002/14651858.CD013105

Perioperative interventions in pelvic organ prolapse surgery

Nir Haya ^1,^✉, Benjamin Feiner ², Kaven Baessler ³, Corina Christmann‐Schmid ⁴, Christopher Maher ⁵

Editor: Cochrane Gynaecology and Fertility Group

PMCID: PMC6513581 PMID: 30121957

Abstract

Background

Pelvic organ prolapse (POP) affects as many as 50% of parous women, with 14% to 19% of women undergoing a surgical correction. Although surgery for the treatment of POP is common, limited supportive data can be found in the literature regarding the preoperative and postoperative interventions related to these procedures. The main goal of perioperative interventions is to reduce the rate of adverse events while improving women's outcomes following surgical intervention for prolapse. A broad spectrum of perioperative interventions are available, and although the benefits of interventions such as prophylactic antibiotics before abdominal surgery are well established, others are unique to women undergoing POP surgeries and as such need to be investigated separately.

Objectives

The aim of this review is to compare the safety and effectiveness of a range of perioperative interventions versus other interventions or no intervention (control group) at the time of surgery for pelvic organ prolapse.

Search methods

We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In Process, ClinicalTrials.gov, WHO ICTRP, handsearching of journals and conference proceedings (searched 30 November 2017), and reference lists of relevant articles. We also contacted researchers in the field.

Selection criteria

We included randomised controlled trials (RCTs) of women undergoing surgical treatment for symptomatic pelvic organ prolapse that compared a perioperative intervention related to pelvic organ prolapse surgery versus no treatment or another intervention.

Data collection and analysis

We used standard methodological procedures recommended by Cochrane. Our primary outcomes were objective failure at any site and subjective postoperative prolapse symptoms. We also measured adverse effects, focusing on intraoperative blood loss and blood transfusion, intraoperative ureteral injury, and postoperative urinary tract infection.

Main results

We included 15 RCTs that compared eight different interventions versus no treatment for 1992 women in five countries. Most interventions were assessed by only one RCT with evidence quality ranging from very low to moderate. The main limitation was imprecision, associated with small sample sizes and low event rates.

Pelvic floor muscle training (PFMT) compared with no treatment (three RCTs) ‐ peri‐operative intervention

The simplest of the PFMT programmes required women to attend six perioperative consultations in the three months surrounding prolapse surgery. Trial results provided no clear evidence of a difference between groups in objective failure at any site at 12 to 24 months (odds ratio (OR) 0.93, 95% confidence interval (CI) 0.56 to 1.54; two RCTs, 327 women; moderate‐quality evidence). With respect to awareness of prolapse, findings were inconsistent. One RCT found no evidence of a difference between groups at 24 months (OR 1.07, 95% CI 0.61 to 1.87; one RCT, 305 women; low‐quality evidence), and a second small RCT reported symptom reduction from the Pelvic Organ Prolapse Symptom Questionnaire completed by the intervention group at 12 months (mean difference (MD) ‐3.90, 95% CI ‐6.11 to ‐1.69; one RCT, 27 women; low‐quality evidence). Researchers found no clear differences between groups at 24‐month follow‐up in rates of repeat surgery (or pessary) for prolapse (OR 1.92, 95% CI 0.74 to 5.02; one RCT, 316 women; low‐quality evidence).

Other interventions

Single RCTs evaluated the following interventions: preoperative guided imagery (N = 44); injection of vasoconstrictor agent at commencement of vaginal prolapse surgery (N = 76); ureteral stent placement during uterosacral ligament suspension (N = 91); vaginal pack (N = 116); prophylactic antibiotics for women requiring postoperative urinary catheterisation (N = 159); and postoperative vaginal dilators (N = 60).

Two RCTs evaluated bowel preparation (N = 298), and four RCTs assessed the method and timing of postoperative catheterisation (N = 514) ‐ all in different comparisons.

None of these studies reported our primary review outcomes. One study reported intraoperative blood loss and suggested that vaginal injection of vasoconstrictors at commencement of surgery may reduce blood loss by a mean of about 30 mL. Another study reported intraoperative ureteral injury and found no clear evidence that ureteral stent placement reduces ureteral injury. Three RCTs reported postoperative urinary tract infection and found no conclusive evidence that rates of urinary tract infection were influenced by use of a vaginal pack, prophylactic antibiotics, or vaginal dilators. Other studies did not report these outcomes.

Authors' conclusions

There was a paucity of data about perioperative interventions in pelvic organ prolapse surgery. A structured programme of pelvic floor muscle training before and after prolapse surgery did not consistently demonstrate any benefit for the intervention; however, this finding is based on the results of two small studies. With regard to other interventions (preoperative bowel preparation and injection of vasoconstrictor agent, ureteral stent placement during uterosacral ligament suspension, postoperative vaginal pack insertion, use of vaginal dilators, prophylactic antibiotics for postoperative catheter care), we found no evidence regarding rates of recurrent prolapse and no clear evidence that these interventions were associated with clinically meaningful reductions in adverse effects, such as intraoperative or postoperative blood transfusion, intraoperative ureteral injury, or postoperative urinary tract infection.

Plain language summary

Perioperative interventions in pelvic organ prolapse surgery

A wide variety of interventions are undertaken at prolapse surgeries; however data are lacking and consensus has not been reached on the efficacy of these interventions. The most reliable evidence is likely to come from randomised controlled trials, and this is the basis for this review.

Review questions

• Which perioperative interventions reduce rates of intraoperative and postoperative complications?

• Which perioperative interventions improve outcomes of surgery performed for pelvic organ prolapse?

Background

Surgery for pelvic organ prolapse is commonly performed and a variety of perioperative interventions are undertaken to improve outcomes of surgery.

Study characteristics

Cochrane review authors evaluated randomised controlled trials (RCTs) that compared prolapse surgery with and without any perioperative (before, during, or after) interventions. The evidence is current to 30 November 2017. Reviewers included 15 trials that evaluated eight different interventions related to prolapse surgery. Although primary outcomes of the review were objective failure (recurrence of prolapse on examination) and awareness of prolapse, reviewers also measured adverse effects, focusing on intraoperative blood loss, intraoperative ureteral injury, postoperative urinary tract infection, and repeat surgery.

Key results

Reviewers found very little evidence on perioperative interventions in pelvic organ prolapse surgery. Few trials reported primary outcomes. A structured programme of pelvic floor muscle training before and after surgery did not consistently demonstrate any benefit for the intervention. With regard to other preoperative interventions, neither bowel preparation nor detailed preoperative mapping demonstrated significant benefit when compared to usual care.

Intraoperative interventions such as injection of a vasoconstrictor agent, ureteral stent placement during uterosacral ligament suspension, or placement of a vaginal pack did not demonstrate benefit for reduced blood loss or rate of urinary tract infection or injury to the ureter.

Vaginal packing postoperatively did not reduce the rate of haematoma (collection of blood) when compared to prolapse surgery without packing in a single trial. The rate of postoperative urinary tract infection was not reduced by use of a vaginal pack, prophylactic antibiotics, or vaginal dilators.

Quality of the evidence

The quality of the evidence ranged from very low to moderate. The main limitation was imprecision, associated with small sample sizes and low event rates.

Summary of findings

Summary of findings for the main comparison. Pelvic floor muscle training before and after prolapse surgery compared to no training in pelvic organ prolapse surgery.

Pelvic floor muscle training before and after prolapse surgery compared to no training in pelvic organ prolapse surgery
Patient or population: women undergoing pelvic organ prolapse surgery  Setting: hospital, in USA and UK  Intervention: pelvic floor muscle training before and after prolapse surgery  Comparison: usual perioperative care
Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect  (95% CI)	№ of participants  (studies)	Quality of the evidence  (GRADE)	Comments
Outcomes	Risk with usual perioperative care	Risk with pelvic floor muscle training before and after prolapse surgery	Relative effect  (95% CI)	№ of participants  (studies)	Quality of the evidence  (GRADE)	Comments
Objective failure at any site: at 12 to 24 months	249 per 1000	235 per 1000  (156 to 337)	OR 0.93  (0.56 to 1.54)	327  (2 studies)	⊕⊕⊕⊝  MODERATE^a	One study followed up only 10/57 and reported no events at 12 months. Not downgraded for risk of bias, as the other much bigger study was at low risk of bias for this outcome in all relevant domains
Subjective awareness of prolapse: Pelvic organ prolapse Symptom score (POP‐SS) at 12 months	Mean score in control group 6.4 points	Mean score in the intervention group 2.5 points. The mean POPSS score was 3.9 points lower (favourable) in the intervention group (6.11 to 1.69 points lower)		48 (1 study)	⊕⊕⊝⊝  LOW^a,b	POPSS includes 7 items, each with a 0 to 5 range. Total score range is 0 to 28 points. A higher score denotes more symptoms.
Subjective awareness of prolapse: feeling of bulge at 24 months	195 per 1000	206 per 1000  (129 to 311)	OR 1.07  (0.61 to 1.87)	305  (1 study)	⊕⊕⊝⊝  LOW^a,b
Intraoperative blood loss	No data were available.
Intraoperative ureteral injury	No data were available.
Postoperative urinary tract infection	No data were available.
Repeat surgery (or pessary) for recurrent prolapse	43 per 1000	79 per 1000  (32 to 183)	OR 1.92  (0.74 to 5.02)	316  (1 study)	⊕⊕⊝⊝  LOW^c
*The risk in the intervention group (and its 95% confidence interval) is based on the mean risk in the comparison group and the relative effect of the intervention (and its 95% CI).    CI: confidence interval; OR: odds ratio; POP‐SS: Pelvic Organ Prolapse Symptom Score.
GRADE Working Group grades of evidence.  High quality: we are very confident that the true effect lies close to that of the estimate of the effect.  Moderate quality: 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 quality: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.  Very low quality: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

	Intervention	Visits	Providers	Follow‐up
Barber 2014	Individualised programme BMPT (behavioural therapy with pelvic floor muscle training)	1 preoperative visit and visits at 2, 4, 6, 8, and 12 weeks postoperatively	Clinicians trained and certified in BMPT after undergoing centralised training	24 months
McClurg 2014	Individualised programme PFMT (pelvic floor muscle training)	1 preoperative visit and 6 postoperative visits during 18 weeks	Women's health physiotherapists	12 months
Pauls 2013	Individualised programme PFMT (pelvic floor muscle training)	1 preoperative visit and visits at 2, 4, 6, 8, and 12 weeks postoperatively	Physiotherapists	12 weeks

Date	Event	Description
22 April 2018	New search has been performed	Comparison of perioperative interventions in pelvic organ prolapse surgery was formerly part of the 2013 Cochrane systematic review titled "Surgical management of pelvic organ prolapse in women". We now present this as a separate systematic review.
22 April 2018	New citation required and conclusions have changed	12 studies have been added to the 2018 review: Adelowo 2017; Antosh 2013; Ballard 2014; Barber 2014; Billquist 2017;Bray 2017; Chan 2014; Dieter 2014; Henn 2016; McClurg 2014; Pauls 2013; Thiagamoorthy 2014. The addition of new studies and more specific focus in this update have led to changes to the conclusions of this review.

Date	Event	Description
14 April 2010	Amended	Changed citation; added conflicts
17 November 2009	New citation required but conclusions have not changed	Full reports of 59 potentially eligible studies were assessed; for this update, 23 new eligible studies were assessed (Al‐Nazer 2007a; Ali 2006a; Allahdin 2008; Barber 2006; Biller 2008; Borstad 2008; Braun 2007a; Carramao 2008a; Constantini 2008; de Tayrac 2008; Dietz 2008a; Glavind 2007; Guerette 2006a; Lim 2007a; Meschia 2007a; Natale 2007; Natale 2009; Nguyen 2008; Nieminen 2008; Pantazis 2008a; Schierlitz 2007a; Segal 2007; Sivaslioglu 2008). Overall, 17 studies were excluded from the review ‐ six during this update (Barber 2006; Biller 2008; Carramao 2008a; Glavind 2007; Meschia 2007a; Segal 2007). Full details are given in the "Characteristics of excluded studies" table. To this, the second update, 18 new trials were added (Al‐Nazer 2007; Ali 2006; Allahdin 2008; Borstad 2008; Braun 2007a; Constantini 2007; Constantini 2008; de Tayrac 2008; Dietz 2008a; Guerette 2006; Lim 2007; Natale 2007; Natale 2009; Nguyen 2008; Nieminen 2008; Pantazis 2008; Schierlitz 2007; Sivaslioglu 2008) and 3 previously included studies were updated (Brubaker 2008; Meschia 2007; Roovers 2004).
9 February 2009	New search has been performed	New search February 2009
10 October 2008	Amended	Converted to new review format
17 April 2007	New citation required and conclusions have changed	Substantive Update, Issue 3, 2007. 22 RCTs (8 new included trials). Findings are still insufficient to provide robust evidence to support current and new practice (such as whether to perform a concurrent continence operation, or to use mesh or grafts).

Do you…	No	Yes
1. Usually experience pressure in the lower abdomen?	0	1 2 3 4
2. Usually experience heaviness or dullness in the pelvic area?	0	1 2 3 4
3. Usually have a bulge or something falling out that you can see or feel in your vaginal area?	0	1 2 3 4
4. Ever have to push on the vagina or around the rectum to have or complete a bowel movement?	0	1 2 3 4
5. Usually experience a feeling of incomplete bladder emptying?	0	1 2 3 4
6. Ever have to push up on a bulge in the vaginal area with your fingers to start or complete  urination?	0	1 2 3 4

Do you…(if Yes is your answer, how much does that bother you)	No	Yes
7. Feel you need to strain too hard to have a bowel movement?	0	1 2 3 4
8. Feel you have not completely emptied your bowels at the end of a bowel movement?	0	1 2 3 4
9. Usually lose stool beyond your control if your stool is well formed?	0	1 2 3 4
10. Usually lose stool beyond your control if your stool is loose?	0	1 2 3 4
11. Usually lose gas from the rectum beyond your control?	0	1 2 3 4
12. Usually have pain when you pass your stool?	0	1 2 3 4
13. Experience a strong sense of urgency and have to rush to the bathroom to have a bowel movement?	0	1 2 3 4
14. Does part of your bowel ever bulge outside the rectum during or after a bowel movement?	0	1 2 3 4

Do you…	No	Yes
15. Usually experience frequent urination?	0	1 2 3 4
16. Usually experience urine leakage associated with a feeling of urgency, that is, a strong  sensation of needing to go to the bathroom?	0	1 2 3 4
17. Usually experience urine leakage related to coughing, sneezing, or laughing?	0	1 2 3 4
18. Usually experience small amounts of urine leakage (i.e. drops)?	0	1 2 3 4
19. Usually experience difficulty emptying your bladder?	0	1 2 3 4
20. Usually experience pain or discomfort in the lower abdomen or in the genital region?	0	1 2 3 4

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Awareness of prolapse	1	305	Odds Ratio (M‐H, Fixed, 95% CI)	1.07 [0.61, 1.87]
2 Pelvic organ prolapse symptom score (POPSS)	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
2.1 6 months	1	48	Mean Difference (IV, Fixed, 95% CI)	0.20 [‐2.18, 2.58]
2.2 12 months	1	27	Mean Difference (IV, Fixed, 95% CI)	‐3.90 [‐6.11, ‐1.69]
3 Objective failure any site (stage 2 or more)	2		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
3.1 Hymen or beyond anterior compartment	1	308	Odds Ratio (M‐H, Fixed, 95% CI)	0.86 [0.44, 1.67]
3.2 Hymen or beyond posterior compartment	1	308	Odds Ratio (M‐H, Fixed, 95% CI)	0.63 [0.15, 2.70]
3.3 Hymen or beyond apical compartment	1	307	Odds Ratio (M‐H, Fixed, 95% CI)	1.06 [0.15, 7.63]
3.4 POP	2	327	Odds Ratio (M‐H, Fixed, 95% CI)	0.93 [0.56, 1.54]
4 Patient Global Impression of Improvement (PGI‐I) much or very much better	1	964	Odds Ratio (M‐H, Fixed, 95% CI)	1.01 [0.76, 1.33]
4.1 PGI‐I 6 months	1	336	Odds Ratio (M‐H, Fixed, 95% CI)	1.09 [0.68, 1.75]
4.2 PGI‐I 12 months	1	324	Odds Ratio (M‐H, Fixed, 95% CI)	0.82 [0.50, 1.35]
4.3 PGI‐I 24 months	1	304	Odds Ratio (M‐H, Fixed, 95% CI)	1.12 [0.69, 1.81]
5 Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ)	2	76	Mean Difference (IV, Fixed, 95% CI)	‐0.78 [‐4.12, 2.56]
6 Short Form Health Survey (SF‐12)	2	74	Mean Difference (IV, Fixed, 95% CI)	4.18 [1.25, 7.10]
7 Postoperative prolapse symptoms (International Consultation on Incontinence Questionnaire)	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
7.1 Urinary incontinence	1	27	Mean Difference (IV, Fixed, 95% CI)	‐0.5 [‐3.22, 2.22]
7.2 Bowel symptoms	1	27	Mean Difference (IV, Fixed, 95% CI)	‐0.80 [‐3.53, 1.93]
8 Any treatment for SUI	1	273	Odds Ratio (M‐H, Fixed, 95% CI)	1.09 [0.68, 1.76]
9 Repeat surgery	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
9.1 Urinary incontinence	1	273	Odds Ratio (M‐H, Fixed, 95% CI)	1.75 [0.56, 5.51]
9.2 Surgery or pessary for recurrent prolapse	1	316	Odds Ratio (M‐H, Fixed, 95% CI)	1.92 [0.74, 5.02]
9.3 Surgery only for recurrent prolapse	1	316	Odds Ratio (M‐H, Fixed, 95% CI)	0.86 [0.23, 3.26]
10 Modified Oxford Pelvic floor contraction grading (0‐5)	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
10.1 Power	1	10	Mean Difference (IV, Fixed, 95% CI)	1.1 [0.17, 2.03]
10.2 Repetitions	1	10	Mean Difference (IV, Fixed, 95% CI)	2.10 [‐0.75, 4.95]
10.3 Endurance	1	10	Mean Difference (IV, Fixed, 95% CI)	‐0.27 [‐3.12, 2.58]
11 Hold with cough (Yes/No)	1	10	Odds Ratio (M‐H, Random, 95% CI)	7.86 [0.28, 217.11]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Patient satisfaction	1	38	Mean Difference (IV, Fixed, 95% CI)	0.5 [‐0.34, 1.34]
2 PFDI score change from baseline to 6 weeks	1	38	Mean Difference (IV, Fixed, 95% CI)	2.30 [‐3.07, 7.67]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Perioperative accessibility: before vaginal prolapse surgery	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
1.1 Assessment of operative field: good or excellent	1	145	Odds Ratio (M‐H, Fixed, 95% CI)	0.59 [0.21, 1.61]
1.2 Stooling on the operative field	1	145	Odds Ratio (M‐H, Fixed, 95% CI)	2.19 [0.71, 6.77]
1.3 Difficulty handling bowel	1	144	Odds Ratio (M‐H, Fixed, 95% CI)	5.14 [0.24, 109.01]
2 Mean time to first bowel movement	1	121	Mean Difference (IV, Fixed, 95% CI)	2.60 [‐7.58, 12.78]
3 Perioperative accessibility: before vaginal prolapse surgery	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
3.1 Assessment of operative field: good or excellent	1	145	Odds Ratio (M‐H, Fixed, 95% CI)	0.59 [0.21, 1.61]
3.2 Stooling on the operative field	1	145	Odds Ratio (M‐H, Fixed, 95% CI)	2.19 [0.71, 6.77]
3.3 Difficulty handling bowel	1	144	Odds Ratio (M‐H, Fixed, 95% CI)	5.14 [0.24, 109.01]
4 Faecal leakage at first bowel movement	1	121	Odds Ratio (M‐H, Fixed, 95% CI)	0.89 [0.32, 2.48]
5 Faecal urgency	1	121	Odds Ratio (M‐H, Fixed, 95% CI)	1.11 [0.54, 2.26]
6 Pain first bowel movement	1	121	Odds Ratio (M‐H, Fixed, 95% CI)	0.52 [0.21, 1.25]
7 Patient satisfaction related to bowel preparation (willing to have the same prep in the future)	1	143	Odds Ratio (M‐H, Fixed, 95% CI)	0.25 [0.05, 1.27]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Quality of surgical field (excellent or good) after initial port placement (less is bad)	1	147	Odds Ratio (M‐H, Fixed, 95% CI)	2.42 [1.15, 5.09]
2 Quality of surgical field (excellent or good) at the conclusion of surgery	1	147	Odds Ratio (M‐H, Fixed, 95% CI)	1.88 [0.74, 4.74]
3 Large bowel assessment via intraoperative palpation and inspection (collapsed)	1	147	Odds Ratio (M‐H, Fixed, 95% CI)	1.10 [0.57, 2.10]
4 Patient's willingness to have same bowel preparation again (less is bad)	1	149	Odds Ratio (M‐H, Fixed, 95% CI)	0.17 [0.06, 0.48]
5 Faecal incontinence	1	149	Odds Ratio (M‐H, Fixed, 95% CI)	0.17 [0.06, 0.48]
6 Hospital stays one night	1	148	Odds Ratio (M‐H, Fixed, 95% CI)	1.89 [0.34, 10.65]

Methods	Trial design: single‐centre, single‐blind randomised controlled trial
Participants	153 enrolled Number of women randomised: 153 (74 intervention group, 79 control group) Number of women analysed: 148 (71 intervention group, 77 control group) Mean age: 48.5 (47.6 to 49.3) years in intervention group, 48.7 (47.7 to 49.5) years in control group Inclusion criteria: women > 18 years of age, stage II or greater apical prolapse, scheduled to undergo laparoscopic or robotic reconstructive prolapse surgery Exclusion criteria: not able to provide informed consent in English; current pregnancy; plans for future pregnancy; history of uterine, cervical, or vaginal cancer; abdominopelvic irradiation; known adverse reactions to synthetic materials; colorectal cancer; contraindication to laparoscopy or use of magnesium citrate Setting: female pelvic medicine and reconstructive surgery clinic at Mount Auburn Hospital, Cambridge, MA, USA Timing: January 2012 to September 2015
Interventions	Intervention: mechanical bowel preparation with 10‐ounce bottle of oral magnesium citrate saline laxative 1 day before surgery with 133 mL sodium citrate enema the night before and the morning of surgery Control: mechanical bowel preparation with sodium phosphate enema alone Both intervention (mechanical bowel preparation) and control: 133 mL sodium phosphate enema the night before and the morning of minimally invasive pelvic reconstructive surgery with or without a concomitant vaginal reconstructive or continence procedure Clear liquid diet the day before surgery, nothing to eat or drink from midnight
Outcomes	Primary outcomes: intraoperative quality of the surgical field measured by a modified version of the self‐administered questionnaire (Yang 2011) completed by the surgeon immediately after the procedure; evaluation of the surgical field as excellent, good, fair, or poor at 2 time points (after laparoscopic port placement and at the end of the procedure) Secondary outcomes: surgeons' assessment of bowel handling, bowel preparation, bowel handling and visualisation (assessed as excellent, good, fair, or poor), and . bowel symptoms (patient‐reported tolerability symptoms in the preop area, assessed by questionnaires regarding bowel and quality of life symptoms (abdominal pain, nausea, and embarrassment rated on a 10‐point severity scale from none to worst possible))
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated block randomisations
Allocation concealment (selection bias)	Low risk	Sealed opaque envelopes (by one of the investigators who was not involved in data collection or assessment of any outcomes)
Blinding of participants and personnel (performance bias)   All outcomes	Unclear risk	Participants could not be blinded to the intervention. Patients were advised not to discuss the assigned bowel preparation with the medical team
Blinding of outcome assessment (detection bias)   All outcomes	Unclear risk	Patients were not blinded to the intervention, which might influence the secondary outcome
Incomplete outcome data (attrition bias)   All outcomes	Low risk	148/153 (97%) completed the study
Selective reporting (reporting bias)	Low risk	None
Other bias	Low risk	Appears free of other biases

Methods	Trial design: single‐centre, parallel randomised controlled trial
Participants	Number randomised: 60 women (30 to vaginal dilator group, 30 to control group) Number analysed: data available on 51 women at 3‐month follow up and on 52 women at 6‐month follow‐up Mean age: 53.9 years (SD 9.6) in dilator group, 51.8 years (SD 11.0) in control group Inclusion criteria: at least 18 years of age, English speaking, sexually active in the past 6 months with heterosexual vaginal intercourse, available for 6‐month follow‐up, able to complete study questionnaires and use vaginal dilators Exclusion criteria: significant baseline dyspareunia (determined by response "usually" or "always" to Question 5: "Do you feel pain with sexual intercourse" on the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire‐12); pregnancy; prior pelvic radiation therapy; active vaginal infection or herpes; posterior colporrhaphy not performed at the time of surgery; postoperative wound complication such as rectovaginal haematoma, mesh erosion, or vaginal wound infection at the 2‐week postoperative randomisation visit Location: Washington, DC, USA Timing: November 2010 to February 2012
Interventions	All participants underwent posterior colporrhaphy via the standard technique or site specific or a combination of both, with a midline posterior vaginal wall incision, +/‐ concomitant surgery ‐ perineorrhaphy, other prolapse/continence procedures (hysterectomy, apical suspension, AC, sling) as required Intervention: vaginal dilator group (n = 30). At the 2‐week postoperative visit, participants randomised to this group were provided with an extra‐small vaginal dilator and printed instructions for vaginal softening exercises, which involved massaging the posterior wall of the vagina gently with the dilator and using lubricating jelly for 5 to 10 minutes daily, commencing 4 to 8 weeks postoperatively. Participants in this group were also provided with a 7‐day diary before the 8‐week and 3‐month follow up visits for assessment of compliance with dilator use Comparison: control group (n = 30): participants in this group were randomised at the 2‐week postoperative visit to no dilator use All participants underwent a pelvic organ prolapse quantification (POPQ) examination and a vaginal calibre measurement at baseline, 3 months, and 6 months postoperatively
Outcomes	Primary outcome: de novo postoperative dyspareunia defined as the response "usually" or "always" on the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire‐12 Question 5 ("Do you feel pain with sexual intercourse?") from a woman who answered "never", "seldom", or "sometimes" on the baseline questionnaire. Secondary outcomes: change in sexual function (using the overall Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire‐12 score before and after surgery), patient satisfaction (using Patient Global Impression of Improvement scores), effect of vaginal calibre, POPQ measurements of sexual function after surgery
Notes	Funding: American Congress of Obstetricians and Gynecologists, Boehringer Ingelheim Pharmaceuticals Inc, Research Award in Female Sexual Dysfunction One study author is a consultant for several pharmaceutical and medical technology companies. The other study authors did not report any potential conflicts of interest.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation occurred at the 2‐week postoperative visit. Quote: "patients were randomized to vaginal dilators or no vaginal dilators by the statistician using a computer generated randomisation schedule"
Allocation concealment (selection bias)	Low risk	Quote: "Group assignments were sealed in consecutively numbered, sealed, opaque envelopes"
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Because of the nature of the study, it was not possible to blind patients or surgeons to the intervention.
Blinding of outcome assessment (detection bias)   All outcomes	Unclear risk	Patients and surgeons were not blinded, but validated questionnaires were utilised to assess subjective outcomes.
Incomplete outcome data (attrition bias)   All outcomes	Unclear risk	Results show 13% loss to follow‐up based on the 6‐month visit ‐ 25/30 women in the vaginal dilator group and 27/30 women with no vaginal dilators (control) attended the 6‐month visit. 22/30 women in the vaginal dilator group and 26/30 women in the control group completed both the 3‐month questionnaire and the 6‐month follow‐up visit. 8 women in the vaginal dilator group and 4 women in the control group are missing follow‐up data at the 3‐month or 6‐month time point, which equates to 20% incomplete data.
Selective reporting (reporting bias)	Low risk	All prespecified outcomes were reported.
Other bias	Low risk	Appears free of other biases

Methods	Trial design: single‐centre, parallel‐arm randomised controlled trial
Participants	Number of women randomised: 150 (75 per group) Number of women analysed: 145 (72 intervention group, 73 control group) Mean age: 62 years (SD 10) in intervention group, 60 years (SD 10) in control group Inclusion criteria: women > 19 years of age, scheduled to undergo reconstructive vaginal prolapse surgery to include an apical suspension with posterior compartment repair Exclusion criteria: colorectal cancer, inflammatory bowel disease, history of bowel resection, neurological disorder, undergoing chemotherapy or radiation, constipation according to Rome III guidelines, pregnancy Setting: Urogynecology Care Clinic at the University of Alabama, Birmingham, Alabama, USA Timing: January 2011 to August 2012
Interventions	Intervention: vaginal surgery with bowel preparation (intake of a clear liquid diet, self‐administration of 2 separate saline enemas at 4 pm and 6 pm the afternoon before the day of surgery, along with nil by mouth after midnight on the day of surgery) Comparison: vaginal surgery without bowel preparation (continuation of regular diet and nil by mouth after midnight on the day of surgery) Both groups were given written instructions on a high‐fibre diet (20 to 25 g/d) as a guideline to follow postoperatively
Outcomes	Primary outcome: surgeon acceptability, measured by a self‐administered questionnaire completed by the primary surgeon to assess the intraoperative surgical field Secondary outcomes: patients' overall satisfaction (assessed by a self‐administered questionnaire consisting of modified patient satisfaction question), severity of perioperative bowel symptoms (including time to first bowel movement, pain, urgency, and faecal leakage)
Notes	Intention‐to‐treat analysis: yes Sample size calculation: sample size of 70 in each group, calculated to provide 80% power to detect a 20% difference in rates of acceptable bowel preparation between groups, with 2‐sided significance of 5%. Seventy‐five participants were recruited to each group to allow for an assumed 7% attrition rate. Trial registration: ClinicalTrials.gov NCT01431040 Funding: in part by the UAB Centre for Clinical and Translational Science, grant number UL1TR00165 from the National Centre for Advancing Translational Sciences (NCATS) and National Centre for Research Resources (NCRR) component of the National Institutes of Health (NIH). Also partially funded by 2K24‐SDK068389 to Holly E Richter from the National Institute of Diabetes and Digestive and Kidney Disease (NIH). Dr Richter is a consultant for several pharmaceutical and medical technology companies. The other study authors reported no potential conflicts of interest.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation sequence
Allocation concealment (selection bias)	Low risk	Quote: "sequentially numbered, opaque, sealed and stapled envelopes"
Blinding of participants and personnel (performance bias)   All outcomes	Low risk	Participants were not blinded owing to the nature of the intervention. Surgical personnel were blinded to group allocation.
Blinding of outcome assessment (detection bias)   All outcomes	Low risk	Data analysts were blinded to group allocation.
Incomplete outcome data (attrition bias)   All outcomes	Low risk	75 women were randomised to each group. 72 in the intervention group received allocated treatment (1 withdrew and 2 had surgery cancelled), and 73 in the control group received allocated treatment (2 withdrew from the study). Secondary analysis was conducted on the 121 women who completed bowel diaries: a 7‐day diary immediately before surgery and a 14‐day diary after surgery (60 in bowel preparation group, 61 in control group).
Selective reporting (reporting bias)	Low risk	All prespecified outcomes were reported.
Other bias	Low risk	Appears free of other biases

Methods	Trial design: multi‐centre, 2 × 2 factorial randomised controlled trial
Participants	Number of women randomised: 374 women (186 to behavioural therapy and pelvic BPMT (Barber 2014; McClurg 2014; Pauls 2013); 91 further randomised to receive ULS as the surgical intervention, 95 to receive SSLF, and 188 usual care (97 further randomised to receive ULS as surgical intervention and 91 to receive SSLF) Number of women analysed: surgical outcome: ULS group, 155 women analysed; SSLF group, 149 women analysed; BPMT group, 153 analysed; usual care group, 164 women analysed Mean age: BPMT group 57.5 years (SD 10.9), usual care group 56.9 years (SD 10.9) Inclusion criteria: women aged > 18 years undergoing vaginal surgery for stage 2 through 4 prolapse (vaginal or uterine descent 1 cm proximal to the hymen or beyond) with complaints of vaginal bulge symptoms, descent of uterus of vaginal apex at least halfway into the vagina, stress incontinence symptoms, and objective demonstration of stress incontinence by office or urodynamic testing in the previous 12 months. Able to complete 24‐month follow‐up and study assessment Exclusion criteria: contraindication to pelvic surgery, history of previous surgery that included SSLF or ULS, pelvic pain or dyspareunia due to levator ani spasm that would preclude a BPMT programme, history of previous synthetic sling procedure for stress incontinence, current or previous ureteral diverticulum, history of femoral‐to‐femoral bypass, current cytotoxic chemotherapy or current or history of pelvic radiation therapy, history of hospitalisation for medical comorbidities in previous 12 months Setting: 9 sites throughout the USA Timing: January 2008 to May 2013
Interventions	Intervention: BPMT group received an individualised programme that included 1 visit 2 to 4 weeks before surgery and 4 postoperative visits (2, 4 to 6, 8, and 12 weeks following surgery) that involved pelvic floor muscle training, individualised progressive pelvic floor muscle exercise, and education on behavioural strategies to reduce urinary and colorectal symptoms, which were performed at each visit. Self‐reported adherence to BPMT was assessed at 6, 12, and 24 months. Visits were conducted by practitioners, all of whom had attended centralised in‐person training before the start of the trial, +/‐ SSLF or ULS surgical procedure (n = 186). Comparison: usual perioperative care, consisting of routine perioperative teaching and standardised postoperative instructions, +/‐ SSLF or ULS surgical procedure (n = 188)
Outcomes	Primary outcome: BPMT assessed at 6 and 24 months Primary 6‐month outcome was urinary symptoms assessed by the Urinary Distress Inventory (UDI) score of the Pelvic Floor Distress Inventory (PFDI). Primary 24‐month outcomes were prolapse symptoms (assessed by the Pelvic Organ Prolapse Distress Inventory (POPDI) score of the PFDI) and anatomic failure (defined as one of the following: descent of vaginal apex more than one‐third into the vaginal canal, anterior or posterior vaginal wall descent beyond the hymen, or retreatment for prolapse). Secondary outcomes: maximum prolapse (anterior, posterior, and apical vaginal segments); retreatment for urinary incontinence, prolapse, or both; urinary, prolapse, and bowel symptoms (measured via PFDI, Incontinence Severity Index); pelvic floor muscle strength (measured by the Brink Grading System)
Notes	Intention‐to‐treat analysis: yes Sample size calculation: yes. Sample size of 170 in each group was calculated to provide 80% power to detect a difference of 0.3 standard deviations in mean UDI score between BPMT and usual care groups, with a 2‐tailed 5% level of significance. Anticipated recruiting 200 per group to allow for 15% dropout rate, but enrolment stopped after 374 participants were randomised, as early loss to follow‐up was less than expected Trial registration: ClinicalTrials.gov NCT00597935 Funding: supported by a number of grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institutes of Health Office of Research on Women's Health Several trial authors disclosed that they received research grants, royalties, or consulting fees from pharmaceutical companies, none of which are directly related to this study. Detailed protocol for this trial was published in the journal Contemporary Clinical Trials 2009;30:178‐89.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were assigned by the data co‐ordinating centre according to a random permuted block design.
Allocation concealment (selection bias)	Low risk	Sequentially numbered, sealed opaque envelopes
Blinding of participants and personnel (performance bias)   All outcomes	Unclear risk	Owing to the nature of the behavioural intervention, blinding of participants or study personnel was not possible.
Blinding of outcome assessment (detection bias)   All outcomes	Low risk	Outcome assessors were blinded to group allocation for surgical intervention and behavioural treatment. Patient‐completed questionnaires were utilised.
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Loss to follow‐up at 2 years BMPT group: 33 Usual care group: 24
Selective reporting (reporting bias)	Low risk	All prespecified outcomes are reported.
Other bias	Low risk	Appears free of other sources of bias

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Blood pressure	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
1.1 Systolic blood pressure ‐ intraoperative	1	76	Mean Difference (IV, Fixed, 95% CI)	13.20 [5.07, 21.33]
1.2 Diastolic blood pressure ‐ intraoperative	1	76	Mean Difference (IV, Fixed, 95% CI)	6.40 [1.58, 11.22]
1.3 Systolic blood pressure ‐ postoperative	1	76	Mean Difference (IV, Fixed, 95% CI)	6.10 [‐2.65, 14.85]
1.4 Diastolic blood pressure ‐ postoperative	1	76	Mean Difference (IV, Fixed, 95% CI)	1.40 [‐4.00, 6.80]
2 Heart rate	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
2.1 Intraoperative heart rate	1	76	Mean Difference (IV, Fixed, 95% CI)	‐3.30 [‐10.90, 4.30]
2.2 Postoperative heart rate	1	76	Mean Difference (IV, Fixed, 95% CI)	‐2.5 [‐8.55, 3.55]
3 Blood loss	1	76	Mean Difference (IV, Fixed, 95% CI)	‐29.60 [‐56.57, ‐2.63]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Postoperative pelvic haematoma at 6 weeks	1	116	Odds Ratio (M‐H, Fixed, 95% CI)	0.45 [0.13, 1.57]
2 Postoperative infection ‐ urinary tract infection	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
2.1 Day 1 postoperative	1	170	Odds Ratio (M‐H, Fixed, 95% CI)	0.85 [0.31, 2.33]
2.2 6‐week follow‐up	1	169	Odds Ratio (M‐H, Fixed, 95% CI)	1.05 [0.50, 2.18]
3 Postoperative infection ‐ vaginal infection	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
3.1 Day 1 postoperative	1	171	Odds Ratio (M‐H, Fixed, 95% CI)	0.79 [0.31, 2.01]
3.2 6‐week follow‐up	1	169	Odds Ratio (M‐H, Fixed, 95% CI)	0.59 [0.31, 1.14]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Urinary tract infection	1	60	Odds Ratio (M‐H, Random, 95% CI)	0.18 [0.05, 0.60]
2 Length of stay (days)	1	60	Odds Ratio (M‐H, Fixed, 95% CI)	0.65 [0.20, 2.05]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Bacteriuria	1	83	Odds Ratio (M‐H, Fixed, 95% CI)	0.24 [0.08, 0.69]
2 Urinary tract infection	1	78	Odds Ratio (M‐H, Fixed, 95% CI)	0.19 [0.06, 0.62]
3 Number of patients who would choose the same treatment	1	87	Odds Ratio (M‐H, Fixed, 95% CI)	1.26 [0.44, 3.65]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Urinary tract infection	1	197	Odds Ratio (M‐H, Fixed, 95% CI)	0.10 [0.04, 0.28]
2 Mean catheter days	1	197	Std. Mean Difference (IV, Fixed, 95% CI)	‐2.17 [‐2.53, ‐1.82]
3 Mean hospital stay (days)	1	197	Mean Difference (IV, Fixed, 95% CI)	‐1.18 [‐1.44, ‐0.92]
4 Repeat catheterisation	1	197	Odds Ratio (M‐H, Fixed, 95% CI)	3.10 [1.30, 7.40]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 UTI at the time of first catheter removal	1	196	Odds Ratio (M‐H, Fixed, 95% CI)	0.48 [0.25, 0.90]
2 Patients needed temporary catheter replacement (events)	1	245	Odds Ratio (M‐H, Fixed, 95% CI)	4.01 [1.93, 8.35]
3 Passed TOV and no UTI at time of first catheter removal	1	245	Odds Ratio (M‐H, Fixed, 95% CI)	1.05 [0.62, 1.78]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Postoperative mesh exposure	1	60	Odds Ratio (M‐H, Fixed, 95% CI)	3.10 [0.12, 79.23]
2 Urinary tract infection	1	60	Odds Ratio (M‐H, Fixed, 95% CI)	4.26 [0.81, 22.53]
3 PGI‐I at 6 months	1	52	Mean Difference (IV, Fixed, 95% CI)	‐0.30 [‐0.63, 0.03]
4 Vaginal calibre	1	49	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐0.93, 0.53]
5 PisQ	1	50	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐2.92, 2.52]
6 PisQ Question 5	1	50	Mean Difference (IV, Fixed, 95% CI)	‐0.30 [‐0.89, 0.29]
7 De novo dyspareunia	1	50	Odds Ratio (M‐H, Fixed, 95% CI)	3.57 [0.35, 36.94]

Methods	Single‐centre constrained randomisation with allocation concealment
Participants	44 enrolled and randomised: 23 to the GIM group and 21 to the control group 39 randomised and underwent surgery: 19 to preoperative guided imagery (GIM); 20 to standard care Inclusion criteria: routine vaginal or laparoscopic pelvic floor surgery, > 1 week from enrolment, planned overnight admission, commitment to a 15‐minute audio CD daily and proficiency in English Location: Loyola University Chicago Time: July 2014 to October 2015
Interventions	GIM preoperative pelvic floor surgery; reviewed 15‐minute CD developed by experienced behavioural specialist in family medicine to prepare for surgery Standard care: included usual preoperative pathway without GIM CD
Outcomes	Evaluated at day of surgery: Anxiety: validated State‐Trait Anxiety Inventory (STAI) Preparedness: unvalidated Likert scale 0 to 10 POPQ examination Pelvic floor distress Inverntory (PFDI) Evaluated at 6 weeks: As above with Patient Global Impression of Improvment (PGI‐I) and satisfaction on unvalidated Likert scale 0 to 10
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Constructive randomisation
Allocation concealment (selection bias)	Low risk	Stated allocation concealment without clarification
Blinding of participants and personnel (performance bias)   All outcomes	Unclear risk	Unable to be blinded
Blinding of outcome assessment (detection bias)   All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias)   All outcomes	Low risk	GIM group: 18/19 completed 6‐week review; standard care control group: 20/20 completed 6‐week review
Selective reporting (reporting bias)	Low risk	None
Other bias	Low risk	None

Methods	Single‐centre randomised controlled trial Post void residual urine volume measured by abdominal ultrasound; bladder volume (mL) = depth × height (sagittal axis) × width (transverse axis) × 0.7
Participants	Number of women randomised: 60 women (31 immediate catheter removal group, 29 SPC group) Inclusion criteria: admitted for prolapse surgery via vaginal route Exclusion criteria: contraindication for suprapubic catheter, inability to give informed consent, concomitant continence procedure (mid‐urethral slings, colposuspension, Kelly plication sutures), preoperative voiding dysfunction, preoperative UTI, intraoperative bladder or bowel injury, requirement for vaginal packing or severe haemorrhage necessitated postoperative monitoring of urinary output
Interventions	Group A: immediate catheter removal as soon as surgery was completed. Patients were encouraged to void as soon as they felt a sense of urge. At 8 hours postoperatively, if the patient had not passed urine, then in/out catheterisation was performed.and was repeated every 8 hours or sooner if the patient felt uncomfortable or was unable to void on 2 occasions. Patients were deemed to have completed the voiding trial once the voided volume was > 200 mL and the residual was consistently < 100 mL and comfortable. Group B: SPC Bonanno suprapubic catheter placed intraoperatively (this was on free drainage until day 2 postoperatively, when it was clamped and patients were encouraged to void spontaneously), passed the post void test if urine residual was < 100 mL (otherwise the SPC was left unclamped overnight and patient renewed TOV) Both groups received intraoperative prophylactic antibiotics.
Outcomes	UTI (positive urine culture > 10⁵ CFU/mL associated with symptoms)
Notes	Many patients undergoing POP procedures require vaginal pack or have a concomitant continence procedure; the results are not applicable for these patients. Therefore this study is relevant only to a relatively small group of patients undergoing POP procedures.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was performed with sealed, sequentially numbered, opaque envelopes. A computer‐generated variable block size was used for randomisation.
Allocation concealment (selection bias)	Low risk	Envelopes were prepared by an independent researcher at the time of surgery.
Blinding of participants and personnel (performance bias)   All outcomes	High risk	Masking of the physician or the patient to the assignment was not feasible given the nature of the intervention.
Blinding of outcome assessment (detection bias)   All outcomes	Low risk	Outcomes were subjective (UTI, day of mobilisation, length of stay).
Incomplete outcome data (attrition bias)   All outcomes	Low risk	None
Selective reporting (reporting bias)	Low risk	None
Other bias	Low risk	Appears free of other biases

Methods	Trial design: single centre, parallel‐arm randomised controlled trial
Participants	Number of women randomised: 93 (46 in preoperative stent group, 47 in no stent group) Number of women analysed: postoperative analysis conducted on 45 women in the preoperative stent group and in 46 in the no stent group Mean age: not stated Inclusion criteria: women with stage II to IV pelvic organ prolapse undergoing apical uterosacral ligament suspension (USLS) with or without total vaginal hysterectomy Exclusion criteria: not stated Setting: Santa Rosa, California, USA Timing: April 2010 to November 2013
Interventions	Intervention group: ureteral stent placement in the operating room before USLS surgery Comparison group: no ureteral stent placement before surgery
Outcomes	Primary outcome: intraoperative ureteral injury with kinking or obstruction during USLS, assessed by administering intravenous blue dye with cystoscopy to confirm bilateral efflux from both ureteral orifices following tying of the suspension sutures Secondary outcomes: not stated
Notes	Intention‐to‐treat analysis: unclear Sample size calculation: not stated Trial registration: not stated Funding: not stated Study authors have no conflicts of interest to disclose.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Patients were randomised using a dynamic allocation approach" ‐ no details of sequence generation
Allocation concealment (selection bias)	Unclear risk	No details of allocation concealment
Blinding of participants and personnel (performance bias)   All outcomes	Unclear risk	Described as single‐blinded ‐ no further details
Blinding of outcome assessment (detection bias)   All outcomes	Unclear risk	Described as single‐blinded ‐ no further details
Incomplete outcome data (attrition bias)   All outcomes	High risk	One woman from each group was excluded from analysis: 1 procedure was aborted owing to dense adhesions, and 1 did not require a vault fixation Data for 1‐month postoperative follow‐up available for 37/45 in the stent group (17% loss to follow‐up) and for 21/46 in the no stent group (55% loss to follow‐up)
Selective reporting (reporting bias)	Low risk	Prespecified primary outcome reported
Other bias	High risk	Conference abstract only

PERMALINK

Perioperative interventions in pelvic organ prolapse surgery

Nir Haya

Benjamin Feiner

Kaven Baessler

Corina Christmann‐Schmid

Christopher Maher

Abstract

Background

Objectives

Search methods

Selection criteria

Data collection and analysis

Main results

Authors' conclusions

Plain language summary

Summary of findings

Summary of findings for the main comparison. Pelvic floor muscle training before and after prolapse surgery compared to no training in pelvic organ prolapse surgery.

Background

Study characteristics

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

Subjective primary outcome

Objective primary outcomes

Secondary outcomes

Subjective secondary outcomes

Quality of life measures

Objective secondary outcomes

Health service outcomes

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

Overall quality of the body of evidence ‐ 'Summary of findings' table

Results

Description of studies

Results of the search

Included studies

Setting

Participants

Interventions

Outcomes

Primary outcomes

Subjective primary outcome

Objective primary outcomes

Secondary outcomes

Subjective secondary outcomes

Quality of life measures

Objective secondary outcomes

Health service outcomes

1.

Excluded studies

Risk of bias in included studies

2.

3.

Allocation

Sequence generation

Allocation concealment

Blinding

Methods	Multi‐centre randomised controlled trial
Participants	Number randomised: N = 87 (147 assessed for eligibility, 16 refused to participate, 38 were not asked to participate, 1 was excluded, 16 refused) Intervention group (clean intermittent catheterisation ‐ CIC): n = 45 Control group (transurethral indwelling catheterisation ‐ TIC): n = 42 Patients older than 18 years experiencing abnormal post void residual (PVR) following vaginal prolapse surgery Exclusion criteria: neurological or anxiety disorder, concomitant continence procedure
Interventions	Intervention group: clean intermittent catheterisation (CIC‐SpeediCath) performed by nursing staff/CISC. Catherisation with maximum interval of 6 hours Control group: IDC (14 French silicone catheter) for 3 days All participants received prophylactic antibiotics during surgery. A 14 French silicone transurethral indwelling catheter (IDC) and a vaginal gauze were inserted directly after surgery. IDC was removed on POD 1, urine residual was > 150 mL (measured by bladder scan) after first void defined as abnormal PVR. Participants were allowed to go home with an indwelling catheter or, when able to self‐catheterise, with instructions to perform clean intermittent self‐catheterisation. In the case of a persistent abnormal PVR after the initial period of 3 days, the surgeon was free to continue treatment by either IDC or CIC.
Outcomes	Primary outcome: bacteriuria. Significant bacteriuria was defined as > 10⁵ colony‐forming units in a culture. Culture was taken from the first void after PVR had normalised to < 150. Secondary outcomes: UTI (bacteriuria, combined with 1 or more: fever, urinary frequency (more than 7 voids a day), dysuria, or lower abdominal pain), duration of catheterisation until normalisation of PVR, number of introductions of the catheter, duration of hospital stay, pain scores, difficulty with catheter use, patient satisfaction (assessed using visual analogue scores ‐ patients were asked to put an ‘X’ on a 10‐cm line, ranging from 0 to 100 between the 2 extremes, and the distance from the beginning of the line to the ‘X’ was measured)
Notes	Netherlands
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computerised block randomisation was performed by the attending residents or gynaecologists.
Allocation concealment (selection bias)	Low risk	The allocation ratio was 1:1. All participants received the allocated intervention, and nobody pulled out of the study.
Blinding of participants and personnel (performance bias)   All outcomes	Unclear risk	Not possible
Blinding of outcome assessment (detection bias)   All outcomes	Unclear risk	Not possible
Incomplete outcome data (attrition bias)   All outcomes	Low risk	None
Selective reporting (reporting bias)	Low risk	None
Other bias	Low risk	Patients were informed about the study preoperatively, and written informed consent was obtained.

Methods	Single‐centre RCT
Participants	200 patients underwent randomisation, 100 to each group; 2 exclusions in intervention group and 1 in control group Inclusion criteria: patients undergoing vaginal prolapse surgery Exclusion criteria: women for whom complicated surgical procedure was anticipated (long‐standing prolapse with severe fibrosis), prolapse surgery associated with plan of bladder or vault suspension or repair by mesh (expected to have higher rate of urinary retention), only posterior colporrhaphy, preoperative UTI
Interventions	Intervention: catheter removed on POD 1 and patient failed TOV if urine residual > 150 mL, recatheterisation until POD 4 (n = 98) Control: catheter removed on POD 4 (n = 99) All participants received 2 doses of antibiotic injection ceftriaxone (1 g) – 1 just before the operation and another dose 12 hours after the first dose. All participants underwent surgery under spinal anaesthesia. Residual urine over 150 mL (ultrasound scan) required recatheterisation. Sample of urine was sent for culture during catheter removal.
Outcomes	Primary outcome: rate of recatheterisation Secondary outcomes: length of hospital stay (time from completion of surgery to hospital discharge), urinary tract infection (positive urine culture taken from catheter before removal of > 10⁵ CFU/mL plus dysuria/fever > 38.5/rigors)
Notes	August 2005 to December 2007 India
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation list drawn up by a statistician
Allocation concealment (selection bias)	Low risk	Assignments were placed in sealed, serially numbered opaque envelopes and were revealed only after the operative procedure had ended.
Blinding of participants and personnel (performance bias)   All outcomes	Low risk	Not possible; not expected to have any effect on the outcome measures
Blinding of outcome assessment (detection bias)   All outcomes	Low risk	Not possible; not expected to have any effect on the outcome measures
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Intervension group: 98/100 completed the study (2 excluded) Control group: 99/100 completed (1 excluded)
Selective reporting (reporting bias)	Low risk	None
Other bias	Low risk	None detected

Methods	Trial design: multi‐centre (3 sites), parallel‐arm randomised controlled feasibility trial
Participants	Number randomised: 57 (perioperative pelvic floor muscle training group n = 28, control group n = 29) Number analysed: at 6‐month follow‐up treatment group n = 23, control group n = 25; at 12‐month follow‐up, treatment group n = 14, control group n = 13 Mean age: no demographic details provided Inclusion: women attending the gynaecological clinic at University Hospitals in any of the specified locations Exclusion: not stated Setting: hospitals in Glasgow (Scotland), Newcastle and Southhamptom (England), and Belfast (Northern Ireland) Timing: not stated
Interventions	Intervention: pelvic floor muscle training programme following surgery to correct pelvic organ prolapse Comparison: control group of women who received no specific pelvic floor exercise direction (1 preoperative and 6 postoperative sessions) All participants received post‐surgery information sheet containing lifestyle advice, including avoidance of heavy lifting and constipation, use of correct defecation technique and bracing. All participants completed questionnaires at baseline (immediately before randomisation) and at 6 months and 12 months after randomisation.
Outcomes	Primary outcome: prolapse symptom severity measured by the Pelvic Organ Prolapse Symptom Score Questionnaire (POP‐SS) at 12 months Secondary outcomes: urinary and bowel symptoms and sexual and general health (measured on International Consultation on Incontinience Questionnaire Urinary Incontinence Short Form (ICIQ‐UI SF) and Bowel Symptom (ICIQ‐BS) Questionnaires, POP/Urinary Incontinence Sexual Questionnaire‐12 (PISQ‐12), and Short Form Health Survey (SF‐12)), degree of prolapse on the POP Quantification (POPQ) scale, and digital pelvic floor muscle evaluation via the Modified Oxford Scale and the PERFECT Scale (P = pre‐presenting power (or pressure, a measure of strength obtained by a manometric perineometer), E = endurance, R = repetitions, F = fast contractions, ECT = every contraction timed)
Notes	Intention‐to‐treat analysis: yes Sample size calculation: not performed as this was a pilot study (provides recommended sample size for future trials based on this study's results) Trial registration: no details of trial registration Funding: Physiotherapy Research Foundation One study author disclosed receiving research grants from pharmaceutical companies, none of which are directly related to this study. Another study author is a speaker for several pharmaceutical companies and is on the Advisory Board of a pharmaceutical company. Two study authors had no financial disclaimers or conflicts of interest.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "randomized using a remote computer programme"
Allocation concealment (selection bias)	Low risk	Quote: "remote computer programme that sent an email with the group allocation of the participant to the researcher, using the identification code initially assigned to the participant"
Blinding of participants and personnel (performance bias)   All outcomes	Unclear risk	Owing to the nature of the intervention, participants and study personnel were not blinded.
Blinding of outcome assessment (detection bias)   All outcomes	Low risk	Outcome examiner physiotherapist was blinded to group allocation.
Incomplete outcome data (attrition bias)   All outcomes	High risk	Treatment group Did not complete 6‐month questionnaire: 5 women (18%) Did not complete 12‐month questionnaire: 14 women (50%) Did not attend 6‐month POPQ and PFM review appointment: 14 women (50%) Did not attend 12‐month POPQ and PFM review appointment: 23 women (82%) Control group Did not complete 6‐month questionnaire: 4 women (14%) Did not complete 12‐month questionnaire: 16 women (56%) Did not attend 6‐month POPQ and PFM review appointment: 18 women (62%) Did not attend 12‐month POPQ and PFM review appointment: 24 women (83%)
Selective reporting (reporting bias)	Low risk	All prespecified outcomes are reported.
Other bias	Unclear risk	Appears free of other sources of bias

Study	Reason for exclusion
Bernades 2012	Bernardes and colleagues used ultrasonography to assess the effects of training programmes by measuring the cross‐sectional area (CSA) of the levator ani muscle ‐ non‐surgery
Butler 2017	Assessed the impact of scopolamine and atropine on postoperative pain not directly relevant to prolapse procedures
Crisp 2012	Assessed the impact of patient‐controlled analgesia (PCA); pain not directly relevant to prolapse procedures
Frawley 2010	Study population is not specific to prolapse procedures and included patients who underwent hysterectomy.
Glavind 2007	Glavind and colleagues compared 3 hours and 24 hours postoperative catheter removal following pelvic organ prolapse surgery. Although this study was very interesting, it was excluded from the review as there was a difference in rates of interventions between groups. Randomisation was performed with sealed envelopes opened at the end of the operation. 100% of patients undergoing enterocoele repair were allocated to the 24 hours group, whereas 84% of those undergoing vaginal hysterectomy and 62% undergoing vaginal hysterectomy with anterior repair were allocated to the 3 hours group.
Gungor 2014	Gungor and colleagues compared post void urine residuals 2, 3, and 4 days post anterior colporrhaphy. Distribution of types of operations and concomitant continence surgery was significantly different between groups.
Jabalameli 2012	Quasi‐randomised study ("randomisation was by personnel (every second patient)"
Jarvis 2005	Included those undergoing incontinence and/or prolapse surgery.
Karp 2012	Assessed the impact of postoperative vaginal oestrogen on patient recovery; vaginal healing measures not included in outcomes
Pauls 2015	Assessed the impact of preoperative dexamethasone on patient recovery; nausea and vomiting not specific to prolapse procedures
Zhu 2014	Impact of preoperative vaginal oestrogen on mesh erosion covered by the mesh review

Methods	Prospective experimental comparative and randomised study
Participants	Forty‐four patients undergoing vaginal surgery for pelvic organ prolapse
Interventions	Hydrodissection with epinephrine (n = 22) or no hydrodissection with epinephrine (n = 22) before surgery
Outcomes	Operative morbidity (infection, haematoma, and surgical postoperative bleeding requiring transfusion), surgical time required to complete the procedure
Notes	Data are not available for analysis.

Methods	Double‐blind placebo‐controlled randomised trial. Block randomisation
Participants	Women scheduled for reconstructive surgery including vaginal hysterectomy and vaginal vault suspension
Interventions	1000 mg of intravenous acetaminophen (n = 47) or 100 mL of placebo (n = 43) every 6 hours for 24 hours
Outcomes	Postoperative pain, satisfaction with pain control
Notes	Data are not available for analysis.

Methods	Randomised double‐blinded placebo‐controlled pilot study
Participants	Women between 18 and 70 years of age who underwent vaginal surgery with apical and/or posterior repair
Interventions	Cyclobenzaprine 5 mg TID (n = 24) or placebo (n = 25) for 7 days following surgery in conjunction with standard postoperative pain medication regimen
Outcomes	Primary outcome: pain score on postoperative day 7 Secondary outcomes: Wexner constipation scores, length of surgery, concomitant surgical procedures, intraoperative and postoperative complication rates, surgical satisfaction, total in‐hospital opioid use
Notes	Data are not available for analysis.