Urinary incontinence (UI) affects millions of women worldwide with a life-time incidence of 40% to 50% for women in the United States.1 It can have a substantial impact on quality of life because women often avoid participating in exercise and social activities outside the home.2 This condition results in the expenditure of billions of dollars in health care costs each year.3 Obesity is also a serious public health issue, with currently more than 40% of US women considered obese.4 Obesity has been implicated in a myriad of medical conditions, including UI.5
In contrast to obesity, normalization of weight (ie, weight loss in obesity) provides many health benefits. Because of this, weight loss interventions have evolved into formalized programs that can involve dramatic behavioral changes and medications, as well as a variety of surgical interventions. Whether these approaches to weight loss should be recommended in overweight and obese women as part of UI and lower urinary tract symptom treatment strategies has not been formalized. Evidence-based interventions that favorably impact UI and overactive bladder (OAB) among overweight women are needed.
The primary aim of this systematic review is to evaluate published data on the impact of behavioral and surgical weight loss (SWL) interventions on lower urinary tract symptoms in overweight and obese women. The review also addresses 3 secondary questions: (1) How does the effect of weight loss interventions on urinary symptoms change over time? (2) What risk factors (eg, comorbidities) explain weight loss intervention results? (3) What are the harms associated with weight loss interventions?
The American Urogynecologic Society Systematic Review Group included 10 board-certified or board-eligible female pelvic medicine and reconstructive surgery physicians who have experience in the treatment of urinary symptoms and incontinence as well as a methods expert in the execution of systematic reviews (M.V.). This project was registered at Prospero (CRD42016035883, https://www.crd.york.ac.uk/PROSPERO/) and was exempt from institutional review board review.
The review group searched PubMED, CINAHL, and the Cochrane Library for English-language articles from January 1, 1990, to December 1, 2018. The search algorithm is available online (Appendix 1, Supplemental Digital Content 1, http://links.lww.com/FPMRS/A96). To establish consensus, all reviewers screened the first 50 abstracts. The remaining abstracts were dually and independently reviewed using Abstrackr (http://abstrackr.cebm.brown.edu/).6 Discordance was adjudicated by a third reviewer. Abstracts that were marked for potential inclusion advanced to dual full-text review. Full-text articles were screened against a set of inclusion and exclusion criteria (see hereafter). Data were extracted from included articles, and a second reviewer ensured the accuracy of extracted data. When possible, effect measures (relative risks, absolute risks, mean differences) were calculated based on raw data reported in the included articles.
Eligible studies included adult women (≥18 years old) who were obese (mean body mass index [BMI], ≥30) with UI or OAB symptoms and enrolled in a behavioral weight loss (BWL) or SWL program. Behavioral weight loss interventions included studies of patients undergoing diet modification, exercise programs, medications, and/or counseling. Studies of patients primarily with interstitial cystitis, bladder pain syndrome, fistulas, pelvic cancer, urinary retention, neurogenic bladder, spinal cord injury, and women who were pregnant or who had undergone pelvic irradiation were excluded. Only data pertaining to women were extracted from included studies. Comparators included studies of other weight loss interventions or programs, delayed intervention, or usual care.
To the extent that they were available, the review group extracted a number of outcomes from included articles. For stress urinary incontinence (SUI), outcomes included cough stress test, urodynamic studies, bladder diary, validated questionnaires including quality of life assessments, pad counts/weight, and other quantitative assessments of UI. For urgency urinary incontinence (UUI), the review group extracted the same outcomes, as well as nocturia episodes. Adverse events (AEs) associated with treatment, including malnutrition and surgical risks, were also collected.
Randomized controlled trials, cohort and case-control were included in this review. Case series were only included if urinary symptoms at baseline and after treatment were reported. Review articles were excluded after reference lists were reviewed for any additional studies that met the inclusion criteria. Authors were contacted as needed to address gaps in reporting. Data reported only in meeting abstracts were not included.
A critical appraisal of individual studies and the body of evidence as a whole was conducted. For individual studies, the risk of bias in randomized controlled trials was assessed with the Cochrane risk of bias tool.7 For observational studies, the risk of bias was assessed with the RTI Item Bank.8 Conflicts were resolved by consensus or adjudication by a third assessor as needed. Bodies of evidence (comprising single or multiple studies with the same population, intervention, comparator, and outcome) were evaluated for risk of bias (high, medium, low), inconsistency, indirectness, imprecision, and publication bias, leading to an overall judgment regarding the certainty of the evidence. Analyses were limited to studies with a comparator arm. Among those studies, certainty for each outcome was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE).9,10 Evidence was graded as high (very confident that the true effect lies close to that of the estimate), moderate (the true effect is likely to be close to the estimate, but there is a possibility that it is substantially different), low (the true effect may be substantially different from the estimate), or very low certainty (very little confidence in the estimate, and the true effect is likely to be substantially different from the estimate).9,10 For case series, we report a descriptive summary of articles without formal grading of the evidence.9
The literature search identified 3006 articles, of which 2819 were excluded based on title and abstract screening. The remaining 187 articles were reviewed in full, and of these, 43 articles (describing 39 unique studies) met the inclusion and exclusion criteria (Fig. 1). The interventions in included studies were categorized as either BWL or SWL. Among the BWL studies, 5 randomized controlled trials (8 articles5,11–17) and 3 case series18–20 were extracted and analyzed. Two additional studies used data from these RCTs. One study was analyzed as a cohort study,21 and the second was an extension trial that reported a combination of randomized and observational data22 (Table 1). Two SWL cohort studies were identified23,24 (Table 2), as well as 28 articles reporting on 27 unique case series25–52 (Table 3). We examined SUI, UUI, and mixed urinary incontinence individually and by length of follow-up. Table 4 provides details on certainty ratings using GRADE.
EFFECTS OF WEIGHT LOSS FROM BWL INTERVENTIONS ON URINARY SYMPTOMS
Stress Urinary Incontinence
Five RCTs and 1 cohort study assessed the effect of weight loss from BWL on SUI. The highest certainty evidence estimated a 15% to 18% decrease in the prevalence of SUI at 1 to 2.9 years postintervention. Two RCTs, Look AHEAD and the Diabetes Prevention Program (DPP), with a total of 4058 female participants compared women who received BWL consisting of caloric restriction and lifestyle coaching sessions with a control group that received education and support.12,13 In Look AHEAD, women in the BWL arm lost a mean of 7.7 kg (SD, 7.0 kg) compared with 0.7 kg (SD, 5.0 kg) in the control arm, with only 8% to 10% attrition over the 12 months of the study.13 The DPP had a third arm, where patients received metformin. In the DPP, women in the BWL group lost a mean of 3.4 kg (SD, 8.2 kg), the metformin group lost a mean 1.5 kg (SD, 7.6 kg), and the placebo group with education gained 0.5 kg (SD, 6.7 kg) over 2.9 years of follow-up.12 In these trials, SUI rates in the comparison arm varied considerably (36.7%12 and 12.8%13). However, both trials reported similar positive effects of weight loss on SUI (calculated risk ratio [RR], 0.85; 95% confidence interval [CI], 0.73–0.9912; RR, 0.82; 95% CI, 0.67–1.01,13 respectively) (Table 4).
The Diabetes Prevention Program Outcome Study (DPPOS),22 an extended follow-up study to the 3-year DPP RCT, followed participants starting 5 years after randomization and continued for 6 additional years as an observational study. For the extension, lifestyle sessions were offered to all participants in all 3 arms as well as unmasked continuation of metformin use for the metformin arm. There was low- to very low–certainty evidence regarding the prevalence of SUI over the long term (>3 years after implementing weight loss program) when comparing BWL (n = 582), metformin (n = 589), and placebo with education/support (n = 607). No difference was noted between SUI in the BWL and generic education/support groups at 5 years (RR, 0.94; 95% CI, 0.80–1.10) and at 10 years (RR, 0.92; 95% CI, 0.81–1.06). During the 6-year follow-up period of the DPPOS study (11 years after the start of the DPP RCT), average weight gain as a percentage of total body weight at entry into the study was 0.4% for BWL, 0.5% in the metformin group, and 0.1% for the placebo group and (P = 0.4).22
There was moderate certainty evidence from 2 RCTs that evaluated the reduction in SUI episodes after 6 months of BWL compared with generic education and support.5,14 In the Program to Reduce Incontinence by Diet and Exercise (PRIDE) study, women in the intervention arm lost an average of 8.0% of their total body weight, compared with 1.6% in the control group (P = 0.01) over a 6-month period.5 Similar results were noted in Gozukara et al’s14 study, in which patients in the intervention arm lost 9.4% of their weight compared with no change in the control group (P < 0.001).14 In the PRIDE study, the BWL arm had an average of 3 fewer SUI episodes per week (95% CI, −4.78 to −1.25)5 and in Gozukara et al’s14 study, there was a mean difference of 3.9 leaks per 3-day period in the ILI group (95% CI, −4.28 to −3.56).14
Another outcome of interest was a 70% reduction in weekly incontinence episodes, a benchmark linked to patient satisfaction in previous studies.53 For this outcome in PRIDE, there was moderate-certainty evidence from 1 RCT in which 50.9% of the BWL group had a 70% reduction in SUI episodes at 6 months compared with only 34.4% in the generic education group (RR, 1.5; 95% CI, 1.09–2.06). In this study, improvement in SUI did not persist at 18 months (RR, 0.98; 95% CI, 0.81–1.20),16 but the quality of this evidence was low owing in part to attrition. However, between 6 months and 18 months, participants in the BWL arm regained some weight but still had greater overall weight loss compared with the control arm (−5.5% vs −1.6% at 18 months, P < 0.001).
Urgency Urinary Incontinence
Five RCTs and 3 case series assessed the impact of BWL versus education on UUI. There was moderate-certainty evidence demonstrating no difference in the prevalence of UUI at 1 to 2.9 years postintervention (calculated RR, 0.92; 95% CI, 0.77–1.1212; RR, 0.93; 95% CI, 0.70–1.23,13 from the DPP and Look AHEAD trials, respectively). At 5 years, there was also no difference between the study arms for prevalence of UUI (RR, 0.91; 95% CI, 0.76–1.09) in the DPP (low certainty).22 Results of DPPOS continued to show no difference between groups at the 11-year follow-up (very low certainty) (Table 4).22
Two RCTs evaluated reduction in UUI episodes after 6 months of ILI compared with education and support, with moderate-certainty evidence supporting a benefit of 1 to 2 fewer UUI episodes per week with ILI (calculated mean difference, −1.4; 95% CI, −1.62 to −1.1814; calculated mean difference, –2; 95% CI, −4.82 to 0.82)5 (moderate). In 1 RCT, no difference was observed between BWL and control in the proportion of women reporting a 70% reduction in weekly UUI at 6 months or 18 months of follow-up (low certainty).16
Three case series18–20 examined urinary symptoms among patients who were given exercise or diet recommendations. Ko et al19 implemented an exercise intervention among 21 patients who were followed for 52 weeks and observed an improvement in OAB symptoms. Patients in the report by Auwad et al18 were enrolled in a weight loss program with or without Xenical, and those who lost more than 5% from baseline had larger improvement in overall urinary symptoms and pad weight (P = < 0.001). Subak et al20 evaluated 10 women after an BWL and observed a decrease in overall UI and urinary frequency.
Overall General Urinary Incontinence
Four RCTs evaluated the impact of BWL on overall UI; of note, all of these studies also reported on SUI and UUI specific symptoms. There was high-certainty evidence that BWL decreased the prevalence of overall UI from 12% to 17% at 1 to 2.9 years.12,13 There was no difference in the prevalence of overall UI at 5 years (low certainty)22 or at 10 years from observational data (very low certainty).22 In the PRIDE study, mean episodes of UI decreased by 4 episodes per week with BWL compared with education (calculated 95% CI, −8.01 to 0.01 episodes per week, low-certainty evidence).5 When evaluating for 70% improvement in weekly UI episodes, there was moderate-certainty evidence of improvement with BWL compared with education at 6 months (RR, 1.9; 95% CI, 1.22–2.84) but low-certainty evidence for ongoing improvement at 18 months (RR, 1.2; 95% CI, 0.86–1.54).16
Urinary Urgency, Frequency, and Nocturia
Two studies evaluated how BWL affected OAB symptoms independent of incontinence. One was a secondary analysis of the PRIDE RCT and assessed change in the prevalence of daytime urinary frequency, nocturia, and urinary urgency after 6 months of BWL or education.17 None of these outcomes differed between the groups (Table 1), but significant improvements compared with baseline were observed in the overall cohort for nocturia (51%–41%, P = 0.009) and urgency (62%–43%, P < 0.001). When participants were stratified by degree of weight loss irrespective of the intervention, there was no difference in urgency, frequency, or nocturia between those who lost more than 5% of body weight compared with those with less than 5% weight loss or gain. A case series by Auwad et al18 assessed nocturia and demonstrated improvement after BWL (odds ratio, 0.33; interquartile range, 0.33–0.67).
Intensive Lifestyle Intervention, Urinary Symptoms, and Improvement in Quality of Life
Three RCTs evaluated quality of life related to urinary symptoms after weight loss intervention. Gozukara et al14 used the Urinary Distress Inventory 6 (UDI-6) and found no change in quality of life after BWL (mean difference, 1.7 points lower [95% CI, −9.06 lower to 5.66 higher]) (low certainty).14 In the PRIDE study, the SF-36, Health Utilities Index Mark 3, and the Estimated Quality of Well-Being survey showed improvement at 6 months and 18 months (low certainty).15 The third RCT was a pilot study and not graded, but it showed improvements on the Incontinence Impact Questionnaire and UDI-6 with BWL compared with education.11
No studies reported on AEs after BWL.
EFFECTS OF SWL ON URINARY SYMPTOMS
No RCTs on SWL for UI were found.
Two prospective cohort studies evaluated the impact of SWL on UI and lower urinary tract symptoms.23,24 Palleschi et al23 compared weight loss after laparoscopic sleeve gastrectomy to women waitlisted for bariatric surgery during the same period and evaluated UUI and OAB. There was very low-certainty evidence showing 1.2 fewer episodes of UUI in 24 hours (95% CI, 0.31–2.09 fewer) in the SWL group 6 months after surgery. This report also showed that the prevalence of UUI decreased 11.7% after SWL compared with waitlisted controls during this timeframe (very low certainty).23 Surgical patients also showed greater improvement on OAB Satisfaction Questionnaire scores (12.18 ± 3.2 vs 16.8 ± 1.1, P < 0.001). Knoepp et al24 matched women who underwent SWL to obese controls in a national private insurance database and showed that diagnoses of overall UI were less prevalent at 5 years post-SWL (37.6% vs 57.9%, P < 0.001). At 3 months of follow-up, the SWL arm experienced an average of 1.2 fewer urge incontinence episodes per day (95% CI, −2.09 to −0.31) (very low certainty). Similarly, prevalence of SUI and UUI after 5 years of follow-up in a study comparing an SWL cohort with controls showed relative risks of 0.60 (95% CI, 0.47–0.76) and 0.67 (95% CI, 0.48–0.93), respectively.24
The review group found 27 unique case series (29 articles) that included 4473 patients who underwent SWL (Table 6). Patients underwent a variety of surgical procedures, including gastric banding, gastric bypass, and sleeve gastrectomy, and were followed from 6 months to 3 years. The reduction in prevalence of SUI and UUI after surgery ranged from 20% to 60%. Patients had mixed results in terms of improvement with urgency symptoms and UUI.
Of the studies included in this systematic review, only 1 case series reported on AEs after SWL, noting 1 patient died of sepsis and bleeding and 2 patients needed reoperation secondary to hernia and small bowel obstruction. This study reported a 22% overall rate of AEs.25 Although AEs at the time of bariatric surgery are well known, identifying and listing all possible AEs with bariatric surgery are beyond the scope of this review. There are numerous benefits to SWL, including health benefits, diabetes control or reversal, and cardiovascular improvements; however, this is also beyond the scope of this review.
This review found high-certainty evidence that BWL programs with intensive lifetyle interventions yield modest improvements in SUI and any UI at 1 to 2.9 years after the intervention.12,13 Reports on these outcomes show a 15% to 18% overall improvement in prevalence in SUI and 12% to 17% improvement in prevalence of UI. Stress urinary incontinence and UUI prevalence and incontinence episodes improved after a 5% to 10% reduction in body weight,21 with further weight loss having minimal additional benefit. There were conflicting data on the impact of BWL on UUI. Studies reporting on prevalence of UUI found no difference after BWL, but those reporting episodes of UUI noted a moderate decrease of 1.4 fewer episodes per week.
Data from studies in this review demonstrated that the weight loss benefits of any BWL diminish over time. This lack of long-term benefit may be attributable to the fact that most patients regain 1 to 2 kg per year after a weight loss program.55 This weight gain may be secondary to low long-term adherence to behavioral regimens or physiologic adaptations that facilitate weight regain.55
For SWL studies, only very low quality data were available from 2 cohort studies. In addition, 27 case series were identified, all of which reported some improvement in urinary symptoms after SWL. Although the data are limited, there seems to be some beneficial impact on urinary symptoms after SWL interventions. No cohorts reported on harms associated with SWL interventions, and the 1 case series that discussed harms reported 1 death, 2 reoperations, and an overall 22% prevalence of AE.25 The harms of surgical intervention for weight loss can be serious,56 and adverse events in up to 37% of patients, with 1 death, were reported in an RCT. Future studies with more consistent reporting of AEs are needed to help health care providers discuss the risks and benefits of surgical weight loss interventions in general and with regard to UI symptoms in particular.
None of the BWL studies reported on harms or adverse cardiac events. These are also rarely reported in the literature,57 and when mentioned, mostly pertain to musculoskeletal exacerbations of chronic conditions.
As with any systematic review, this report is limited by the available data. The paucity of data suggests that there is room for future research in the arena of weight loss and UI. There is also a need for additional SWL studies with more robust weight loss to assess if the degree of weight loss affects UI in a dose-response fashion. Randomized surgical trials are lacking at this time and could be designed to compare different surgical techniques in the future. In addition, higher-quality comparative studies enrolling women with bothersome UI and OAB at baseline are needed, rather than convenience samples in bariatric offices. Because there were so few studies with adequate numbers to report on the impact of UI improvements with certain comorbidities, this could not be reported in the current review. In addition, several studies only used questionnaires and no physical examination or other objective outcome measure (eg, voiding diary). Studies were not all powered for UI outcomes.
Future research would benefit from standardized definitions of UI and objective outcome measures such as voiding diaries and pad counts, in addition to the use of validated questionnaires. Moreover, most studies in this review included at least some patients with no urinary symptoms at baseline, making a substantial difference in improvement in UI symptoms difficult to demonstrate. Higher-quality studies evaluating the impact of weight loss on OAB symptoms and nocturia could improve care for these patients. Ideally, future studies would generate high-quality data that show, for a patient with a given set of characteristics, how much exercise and caloric intake are needed to generate a specified reduction in incontinence episodes. Improvements in overall UI including subtypes SUI and UUI related to weight loss wane over time in both quality and effect. At this time, owing to a lack of high quality data, no recommendation can be made to support weight loss for the indication of long-term improvement of UI. The modest and short-term improvement in UI after weight loss means that we should not delay care for women with urinary symptoms if they are not interested in weight loss regimens. There are currently more effective treatment modalities that result in more sustained improvement in UI.
The authors would like to thank Shannon Potter, MLIS, for her assistance and expertise with conducting a comprehensive literature search.
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