Abstract
Purpose
Approximately 50%–60% of adult women experience at least one episode of urinary tract infection (UTI) during their lifetime, with 20%–24% of them experiencing recurrence within a year. Several randomized controlled trials have explored the efficacy and safety of D-mannose for the prevention of UTI in adult women but reported conflicting results.
Objective
We performed a meta-analysis comparing D-mannose with placebo or no treatment for the prevention of UTI in adult women.
Methods
We systematically searched PubMed, Scopus, and Cochrane Central databases for studies comparing D-mannose with placebo or no treatment for the prevention of UTI in adult women. The outcomes of interest were recurrent UTIs during follow-up and adverse events. Heterogeneity was assessed using I2 statistics. Analysis followed the PRISMA guideline and was registered in the PROSPERO database.
Results
The systematic review identified 4 randomized controlled trials (RCTs) including 890 participants (D-mannose n = 447, 50.22%). Recurrent UTI (RR 0.44; 95% CI 0.18–1.11; p = .082; I2 = 90%) and adverse events (RR 2.19; 95% CI 0.68–7.05; p = .190; I2 = 79%) did not differ significantly between the groups at the end of follow-up.
Conclusion
Prophylaxis with D-mannose did not cause any difference in the risk of recurrent UTI during follow-up and adverse events in adult women. Fewer number of studies and heterogeneity in the results make it difficult to draw conclusions about the efficacy of D-mannose in preventing recurrent UTI. More placebo-controlled RCTs are required to confirm the efficacy and safety.
Keywords: D-mannose, urinary tract infection, recurrent UTI
Introduction
Approximately 50–60% of adult women experience at least one episode of urinary tract infection (UTI) during their lifetime (Medina and Castillo-Pino, 2019). An estimated 20%–40% of them will experience a recurrence within the following year (Anger et al., 2019). Recurrent UTI is defined as ≥2 episodes of UTI in 6 months or ≥3 episodes within 1 year (Albert et al., 2004). This can impede the quality of life due to distressing symptoms and systemic illnesses (Izett-Kay et al., 2022). Prolonged antibiotic therapy for UTI prophylaxis poses the risk of antibiotic resistance, alteration of normal flora, and high costs to the patient (Patangia et al., 2022). It is estimated that the treatment and evaluation of UTIs cost about 2 billion dollars in the United States and several billion dollars annually globally (Foxman, 2002). Hence, non-antibiotic prophylactic measures for recurrent UTIs have been the subject of research. D-mannose, a monosaccharide, may reduce UTI by preventing the adherence of bacteria to uroepithelium by binding to the type 1 pili and saturating the adhesin FimH (Wagenlehner et al., 2022). D-mannose is commonly marketed for urinary tract health and is touted to contribute to better antimicrobial management within primary care settings. This can be an alternative to antibiotic prophylaxis for UTIs and promote antimicrobial stewardship (Ala-Jaakkola et al., 2022). Several randomized controlled trials (RCTs) have explored the efficacy and safety of D-mannose for the prophylaxis of UTI in adult women, but reported conflicting results (Hayward et al., 2024; Kranjčec et al., 2014;). Therefore, we performed a meta-analysis comparing prophylaxis with D-mannose versus placebo or no treatment for the prevention of recurrent UTI in adult women.
Methods
Data source and search strategy
This systematic review and meta-analysis were performed per the Cochrane Collaboration recommendations and were designed following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines (Higgins et al., n.d.); (Page et al., 2021). The protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO) on November 23, 2024. PubMed, Scopus, and the Cochrane Central Register of Controlled Trials databases were systematically searched from their inception through November 2024 with the following search terms: “D-Mannose,” “Urinary Tract Infection,” “UTI,” “Cystitis,” and “Prophylaxis.” The references from all identified studies, previous systematic reviews, and meta-analyses were also searched manually for additional studies. No language, sample size, publication date, or publication status restrictions were placed on the search. The search strategy used is summarized in the Supplemental Appendix. Two authors independently reviewed titles and abstracts to identify candidate studies. A full-text review was performed to select studies that met the inclusion criteria. Two authors then extracted data into tables following predefined criteria and performed quality assessment. Disagreements were resolved by discussion to reach a consensus.
Study eligibility
Studies were included in the meta-analysis according to the following eligibility criteria: (1) RCTs; (2) comparing D-mannose with placebo or no treatment for prevention of recurrent UTI in adult women; and (3) with follow-up of at least 90 days. In addition, studies were included only if they reported any clinical outcomes of interest. We excluded studies with (1) no control group; (2) overlapping populations; (3) non-randomized designs; and (4) studies using other active control groups.
Outcomes
The outcomes of interest were recurrent UTI during follow-up and adverse events.
Data analysis and quality assessment
Risk ratios (RRs) with 95% confidence intervals (CIs) were calculated from the available data in the included studies. Study-specific RRs were combined using the DerSimonian and Laird random-effects model, with the estimate of heterogeneity taken from the Mantel-Haenszel model. A 2-tailed alpha value of p < .05 was considered statistically significant. The “test for overall effect” was reported as a z-value corroborating the inference from the 95% CI. The Higgins I-squared (I2) statistic was used to quantify heterogeneity among the included studies; values of 25%, 50%, and 75% have been assigned adjectives of low, moderate, and high heterogeneity, respectively. All statistical analyses were performed using R statistical software, version 4.3.2 (R Foundation for Statistical Computing, London, UK). Leave-one-out sensitivity analysis was performed by repeating the analyses after systematically excluding each study from the outcome assessment, as detailed in the Supplemental Appendix. The risk of bias was evaluated using version 2 of the Cochrane Risk of Bias assessment tool (Sterne et al., 2019).
Results
Study selection and baseline characteristics
The systematic search yielded 266 potential articles. After removing duplicate records and performing a title/abstract review, 7 remained and underwent full-text review for inclusion and exclusion criteria. Ultimately, 4 RCTs were included in the analysis. (Domenici et al., 2016; Hayward et al., 2024; Kranjčec et al., 2014; Lenger et al., 2023;). Figure 1 displays the PRISMA flow diagram for study search and selection. Three studies were excluded after full-text review for the following reasons: (1) antibiotic used in the control group (Porru et al., 2014); (2) D-mannose used in combination with other agents in the intervention arm (Genovese et al., 2018); and (3) higher and lower doses of D-mannose used in combination with other agents in the intervention and control arms (Efros et al., 2010).
Figure 1.
PRISMA methodology flowchart of the systematic review.
All the RCTs included adult women (≥18 years) as participants. There were 890 participants, of whom 447 (50.22%) were on prophylaxis with D-mannose. The definition of UTI was consistent across the included studies, except Hayward et al., with UTI defined as a positive urine culture, reported as ≥103 colony-forming units per milliliter of urine. Hayward et al. enrolled women with clinically suspected UTI based on self-reporting (Hayward et al., 2024). All the included studies defined recurrent UTI as ≥2 episodes of UTI in 6 months or ≥3 episodes in 1 year. Three trials followed the patients for 6 months, while 1 trial had a follow-up of 90 days (Lenger et al., 2023). The dose of D-mannose used in the trials was also identical (2 g daily) except for one trial administering 1.5 g daily (Domenici et al., 2016). Characteristics of included trials are listed in Table 1. Baseline clinical characteristics are presented in Table 2.
Table 1.
Characteristics of included trials.
| Study, year | Study design | Study population | Inclusion criteria | Exclusion criteria | D-mannose group | Control group | Definition of UTI | Location |
|---|---|---|---|---|---|---|---|---|
| Kranjcec et al. (2014) | Prospective randomized controlled trial | Women aged >18 y | Acute cystitis and history of recurrent UTIs | Pregnant, breastfeeding, or trying to conceive, had symptoms of upper UTI, and symptoms of systemic inflammatory response (fever over 38 °C and white blood cell count over 12,000), history of urinary tract anomalies, interstitial cystitis or diabetes, taking hormone therapy, contraception, or history of antibiotic prophylaxis | 2 g of oral D-mannose powder (diluted in 200 mL of water) once daily in the evening for 6 months | Untreated | 103 or more colony-forming units in 1 mL of clean voided midstreamurine, and at least two of the following lower urinary tract symptoms: Dysuria, frequency, urgency, suprapubicpain, nocturia, and hematuria | Croatia |
| Domenici et al. (2016) | Randomized controlled trial | Women, aged 18–65 y | Acute cystitis and history of recurrent UTIs | History of urinary tract anomalies and acute symptoms | Oral Mannocist daily (for 1 week every other month) X 6 months | Untreated | Symptomatic or asymptomatic patients 103 or more colony-forming units in 1 mL of clean voided midstream urine | Italy |
| >1 week before the first visit, pregnancy/breast feeding, trying to conceive, symptoms of upper UTI, and symptoms of systemic inflammatory | ||||||||
| UTI (fever over 38°C and white blood cell count over 12,000), taking hormone therapy, interstitial cystitis or diabetes, use of CISC, or history of antibiotic prophylaxis, and patients unable to fill out the questionnaire | ||||||||
| Lenger et al. (2023) | Randomized controlled trial | Postmenopausal women with recurrent UTIs | ≥1 documented prior uropathogen susceptible to D-mannose and use of vaginal estrogen therapy for a minimum of 4 weeks before randomization | (a) Current daily antibiotic UTI prophylaxis; (b) complicated UTIs; (c) incomplete bladder emptying; (d) known contraindication to VET; (e) history of interstitial cystitis/painful bladder syndrome; (f) urothelial cancer; (g) non-English-speaking; or (h) enrolled in other UTI clinical trials | 2 g D-mannose powder of powder in 6–7 oz of water once a day X 90 days | No additional therapy | UTI symptoms with a uropathogen-positive culture reported with at least 103 colony-forming units | United States of America |
| Hayward et al. (2024) | Double-blind, placebo-controlled randomized clinical trial | Women aged >18 y | Symptoms consistent with UTI three or more times in the last year or two or more times in the last 6 months | Pregnancy/breastfeeding or planning pregnancy during the course of the study interstitial cystitis or overactive bladder syndrome, taking prophylactic antibiotics started in the last 3 months and unwilling to discontinue, or intention to start during the next 6 months | 2 g of D-mannose powder daily X 6 months | A daily scoop of fructose powder in the placebo arm | Symptoms consistent with UTI with positive urine culture reported as ≥103 colony-forming units | United Kingdom |
| Currently using D-mannose and unwilling to discontinue for the duration of the study, nursing home resident, catheterized, and use of CISC | ||||||||
| Use of Uromune, participation in a research study involving an IMP in the past 12 weeks, and previous participation in this study |
UTI- urinary tract infection, CISC- Clean Intermittent Self-Catheterization, IMP- investigational medicinal product, VET- vaginal estrogen therapy.
Table 2.
Baseline clinical characteristics of patients across included trials.
| Study, y | Subjects, n (intervention/control) | Age, y (intervention/control) | BMI, n (intervention/control) | Sexually active, % (intervention/control) | Postmenopausal, % (intervention/control) | Contraceptive use, % (intervention/control) | Cystitis in the past 6 months, n (intervention/control) | Isolated bacteria in acute cystitis, % (intervention/control) |
|---|---|---|---|---|---|---|---|---|
| Kranjčec et al. (2014) | 103/102 | 49/52 | 28.5/28.6 | 67/66.7 | 50.5/51.0 | 40.7/38.2 | 2/2 | E Coli: 78.6/75.5; Other: 12.6/16.7 |
| Domenici et al. (2016) | 22/21 | 46.7 | 22.5 | 69.7 | 51.2 | 20.9% | 2.3 ± 1.7 | E Coli: 81.4; Other: 13.9; NA: 4.6 |
| Lenger et al. (2023) | 19/25 | 72.0/67.3* | 27.8/29.3 | 36.8/20.0 | 100/100 | NA | NA | E Coli: 89.4/92; Klebsiella: 31.5/28.0; Proteus: 5.26/12.0; Enterococcus: 21.0/24.0; Staphylococcus: 5.26/4.0; Other: 5.26/20.0 |
| Hayward et al. (2024) | 303/295 | 58.6/57.3 | NA | 0.5/0.5* | 64.0/62.1 | 21.7/20.2* | 1.58/1.53 | NA |
Values are in mean or median. * are estimated values from different groups given. NA: No information available.
Quality assessment
Risk of bias assessment identified 2 studies to have a high risk of bias (Domenici et al., 2016; Lenger et al., 2023). The study by Domenici et al. was found to have a high risk of bias in the measurement of the outcomes. Additionally, there were some concerns of bias arising from the randomization process and deviations from intended interventions. Lenger et al. had a high risk of bias due to deviations from the intended intervention and missing outcome data. There were some concerns of bias in the study by Kranjčec et al. in the randomization process (Kranjčec et al., 2014). The study by Hayward et al. was found to have a low risk of bias (Hayward et al., 2024) (Figure 2).
Figure 2.
Risk of bias assessment for the included studies.
Outcomes
The results of all pooled analyses are summarized in Figure 3.
Figure 3.
Results of all pooled analyses.
The results of the analysis found no significant difference in recurrent UTI during follow-up (RR 0.44; 95% CI 0.18–1.11; p = .082; I2 = 90%) and adverse events (RR 2.19; 95% CI 0.68–7.05; p = .190; I2 = 79%) between the groups (Figures 4-5). The quality and strength of the results should be interpreted with caution due to the high degree of heterogeneity in the analyses.
Figure 4.
Results of pooled analysis for the outcome of recurrent UTI during follow-up.
Figure 5.
Results of pooled analysis for the outcome of adverse events.
Sensitivity analysis
To identify studies influencing the analysis and contributing to the overall between-study-heterogeneity, sensitivity analysis was done using leave-one-out analysis. Leave-one-out analysis found a statistically significant reduction in recurrent UTI during follow-up with the exclusion of the trial by Hayward et al. The leave-one-out sensitivity analysis for the outcomes was similar to the results of the main analysis for adverse events (Supplemental Figures A1-A2). The overall between-study-heterogeneity persisted in the leave-one-out analyses for both the outcomes.
Discussion
This meta-analysis of 890 participants compared the efficacy and safety of D-mannose for the prophylaxis of recurrent UTIs in adult women. The results of this study did not find any significant difference in the risk of recurrent UTI during follow-up and adverse events with D-mannose compared with placebo or no treatment.
The comparable risk of recurrent UTI in both groups was consistent with the result of a previous systematic review (Cooper et al., 2022). The review by Cooper et al. compared D-mannose with other agents for the prevention of recurrent UTI in males and females and reported no difference in the risk of recurrent UTI between the two groups. Though the authors reported a significant reduction in the risk of recurrent UTI with D-mannose in a subgroup analysis comparing D-mannose with no treatment, it was solely based on the trial by Kranjčec et al. The findings of our study are different from a previous meta-analysis, which reported a decreased risk of recurrent UTI with D-mannose prophylaxis (Lenger et al., 2020). This analysis however, included only two studies (Domenici et al., 2016; Kranjčec et al., 2014;). Our meta-analysis has included two more recent trials on the topic significantly increasing the sample size which could explain the difference in the results.
One of the included trials, Kranjcec et al., reported a reduction in the risk of recurrent UTI in the D-mannose group (Kranjčec et al., 2014). All the other included trials reported no difference in the risk of recurrent UTI between the groups (Domenici et al., 2016; Hayward et al., 2024; Lenger et al., 2023). Not surprisingly, the heterogeneity of the analysis reduced considerably with the exclusion of Kranjcec et al. in the leave-one-out analysis (Supplemental Figure A2). Upon excluding Hayward et al. in the leave-one-out analysis, a statistically significant reduction in recurrent UTI was found. This could be due to this trial being the one with the largest sample size, influencing the overall analysis. It is noteworthy that the trial by Hayward et al. enrolled participants based on self-reported symptoms which could have encompassed a wide range of other causes for the symptoms, thereby making the impact of D-mannose less obvious.
The risk of adverse events was also comparable between the two groups. This was consistent with the findings of previous systematic reviews and meta-analyses (Cooper et al., 2022; Lenger et al., 2020). All 4 of the included trials also reported similar risk of adverse events in both groups.
The results of the analysis do not confirm the efficacy of D-mannose for the prophylaxis of recurrent UTIs in adult women. However, the possibility of a beneficial effect cannot be ruled out. Some of the key differences between the studies should be considered while interpreting the results of the analysis. Kranjčec et al. and Domenici et al. recruited patients from secondary care (Domenici et al., 2016; Kranjčec et al., 2014). Lenger et al. included a specific group of postmenopausal women on vaginal estrogen therapy (VET) while Hayward et al. were based on patients in the community, who self-reported symptoms (Hayward et al., 2024; Lenger et al., 2023). The probable variable etiology that drives symptom presentation in these diverse groups of patients limits the generalizability of the findings. D-mannose seems to be well-tolerated without any increased risk of adverse events. Data from more studies would aid in reaching a definite conclusion on the use of D-mannose for the prevention of recurrent UTI. Additional placebo-controlled RCTs exploring the efficacy and safety of D-mannose for recurrent UTI prophylaxis are necessary.
Newer studies on synthetic mannosides have shown promising results in preventing recurrent UTIs in mouse models (Han et al., 2012; Spaulding et al., 2017). Investigational vaccine against the Escherichia coli adhesin antigen, FimH, was found to increase the antibodies against the antigen by 150-fold in a Phase 1 study (Eldridge et al., 2021). Innovative developments like these in recurrent UTI prophylaxis offer newer options.
Our study has several limitations that must be acknowledged. First, 3 of the included trials were not placebo-controlled (Domenici et al., 2016; Kranjčec et al., 2014; Lenger et al., 2023) and 2 had a high risk of bias (Domenici et al., 2016; Lenger et al., 2023), limiting the quality of the results of our analysis. Second, the duration of D-mannose prophylaxis was different for one of the studies (Lenger et al., 2023). Third, one of the trials exclusively included postmenopausal women on VET (Lenger et al., 2023). However, VET was provided in both arms of the trial, thereby alleviating a difference between the two arms. Additionally, although the analysis was performed using a random-effects model to minimize heterogeneity, potential heterogeneity in the methods, patients, sample size, and baseline characteristics of the patients still existed; therefore, caution should be taken when interpreting the results. Our study also has several important strengths to highlight. Our study was purely based on RCTs, thereby reducing the risk of known and unknown confounders. Most importantly, the present study’s sample size considerably exceeds those of prior analyses. With increased sample size comes increased statistical power, and hence, conclusions from the present study carry additional strength.
Conclusion
In this meta-analysis, prophylaxis with D-mannose was not found to cause any difference in the risk of recurrent UTI during follow-up and adverse events in adult women. The limited number of studies and the considerable heterogeneity in the analysis offer insufficient evidence to support or refute the use of D-mannose to prevent recurrent UTI in adult women. More placebo-controlled RCTs are required to confirm the efficacy and safety.
Supplemental Material
Supplemental Material for D-Mannose for prevention of recurrent urinary tract infection in adult women: An updated systematic review and meta-analysis of randomized controlled trials by Mrinal Murali Krishna, Meghna Joseph, Vinicius Pereira, Afshan Nizami, Chidubem Ezenna, and Lal Sadasivan Sreemathy in Journal of Infection Prevention.
Appendix.
Abbreviations
- CI -
confidence interval
- PRISMA -
Preferred Reporting Items for Systematic Review and Meta-analysis
- PROSPERO -
the International Prospective Register of Systematic Reviews
- RCT -
randomized controlled trial
- RoB2 -
Risk of Bias Assessment Tool 2
- RR -
risk ratio
- UTI -
urinary tract infection.
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding: The authors received no financial support for the research, authorship, and/or publication of this article.
Supplemental Material: Supplemental material for this article is available online.
ORCID iDs
Mrinal Murali Krishna https://orcid.org/0009-0003-8894-4443
Meghna Joseph https://orcid.org/0009-0002-5422-2605
Vinicius Pereira https://orcid.org/0009-0008-3786-9259
Afshan Nizami https://orcid.org/0009-0006-6797-5066
Chidubem Ezenna https://orcid.org/0009-0001-3988-6211
Lal Sadasivan Sreemathy https://orcid.org/0009-0001-0987-7162
Data Availability Statement
All data used in this study are publicly available from the publications of the studies comprising the meta-analysis. The authors of this study do not have access to patient-level data from the individual studies.*
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Supplemental Material for D-Mannose for prevention of recurrent urinary tract infection in adult women: An updated systematic review and meta-analysis of randomized controlled trials by Mrinal Murali Krishna, Meghna Joseph, Vinicius Pereira, Afshan Nizami, Chidubem Ezenna, and Lal Sadasivan Sreemathy in Journal of Infection Prevention.
Data Availability Statement
All data used in this study are publicly available from the publications of the studies comprising the meta-analysis. The authors of this study do not have access to patient-level data from the individual studies.*