Dataset Information

Effect of pelvic floor muscle training on reports of urinary incontinence in obese women undergoing a low-calorie diet before bariatric surgery - protocol of a randomized controlled trial.

ABSTRACT:

Background

Obesity represents a growing threat to health with multiple negative impacts including urinary incontinence. Pelvic floor muscle training (PFMT) is the first line of treatment for urinary incontinence. Both surgical and conservative weight loss results in improvement of urinary incontinence reports in obese women and we hypothesize that a low-calorie diet in combination with PFMT would result in additional beneficial effects to urinary symptoms in women with UI compared would with weight loss alone.

Objective

To assess the effect of a low-calorie diet plus PFMT protocol in obese women's urinary incontinence reports.

Methods

This is a protocol for a randomized controlled trial that will include obese women reporting UI and being able to contract their pelvic floor muscles. The participants will be randomly allocated in two groups: group 1 will participate in a 12-week protocol of low-calorie diet delivered by a multi-professional team at a tertiary hospital; group II will receive the same low-calorie diet protocol during 12 weeks and will additionally participate in 6 group sessions of supervised PFMT delivered by a physiotherapist. The primary outcome of the study is self-reported UI, and severity and impact of UI on women's quality of life will be assessed by the ICIQ-SF score. The secondary outcomes will be adherence to the protocols assessed using a home diary, pelvic floor muscle function assessed by bidigital vaginal palpation and the modified Oxford grading scale, and women's self-perception of their PFM contraction using a questionnaire. Satisfaction with treatments will be assessed using a visual analog scale. The statistical analysis will be performed by intention to treat and multivariate analysis of mixed effects will be used to compare outcomes. The complier average causal effects (CACE) method will be used to assess adherence. There is an urgent need for a high-quality RCT to investigate if the association of a low-calorie diet and PFMT can provide a larger effect in the improvement of urinary incontinence reports in women with obesity.

Trial registration

Clinical Trials NCT04159467. Registered on 08/28/2021.

SUBMITTER: Mendes PCS

PROVIDER: S-EPMC10240468 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of pelvic floor muscle training on reports of urinary incontinence in obese women undergoing a low-calorie diet before bariatric surgery - protocol of a randomized controlled trial.

Mendes Pauliana C S PCS Fretta Tatiana B TB Camargo Milena F C MFC Driusso Patricia P Homsi Jorge Cristine C

Trials 20230605 1

<h4>Background</h4>Obesity represents a growing threat to health with multiple negative impacts including urinary incontinence. Pelvic floor muscle training (PFMT) is the first line of treatment for urinary incontinence. Both surgical and conservative weight loss results in improvement of urinary incontinence reports in obese women and we hypothesize that a low-calorie diet in combination with PFMT would result in additional beneficial effects to urinary symptoms in women with UI compared would ...[more]

PMID: 37277833

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Project description:ImportanceAmong women and men with severe obesity, evidence for improvement in urinary incontinence beyond the first year after bariatric surgery-induced weight loss is lacking.ObjectivesTo examine change in urinary incontinence before and after bariatric surgery and to identify factors associated with improvement and remission among women and men in the first 3 years after bariatric surgery.Design, setting, and participantsThe Longitudinal Assessment of Bariatric Surgery 2 is an observational cohort study at 10 US hospitals in 6 geographically diverse clinical centers. Participants were recruited between February 21, 2005, and February 17, 2009. Adults undergoing first-time bariatric surgical procedures as part of clinical care by participating surgeons between March 14, 2006, and April 24, 2009, were followed up for 3 years (through October 24, 2012).InterventionParticipants undergoing bariatric surgery completed research assessments before the procedure and annually thereafter.Main outcomes and measuresThe frequency and type of urinary incontinence episodes in the past 3 months were assessed using a validated questionnaire. Prevalent urinary incontinence was defined as at least weekly urinary incontinence episodes, and remission was defined as change from prevalent urinary incontinence at baseline to less than weekly urinary incontinence episodes at follow-up.ResultsOf 2458 participants, 1987 (80.8%) completed baseline and follow-up assessments. At baseline, the median age was 47 years (age range, 18-78 years), the median body mass index was 46 kg/m2 (range, 34-94 kg/m2), and 1565 of 1987 (78.8%) were women. Urinary incontinence was more prevalent among women (49.3%; 95% CI, 46.9%-51.9%) than men (21.8%; 95% CI, 18.2%-26.1%) (P < .001). After a mean 1-year weight loss of 29.5% (95% CI, 29.0%-30.1%) in women and 27.0% (95% CI, 25.9%-28.6%) in men, year 1 urinary incontinence prevalence was significantly lower among women (18.3%; 95% CI, 16.4%-20.4%) and men (9.8%; 95% CI, 7.2%-13.4%) (P < .001 for all). The 3-year prevalence was higher than the 1-year prevalence for both sexes (24.8%; 95% CI, 21.8%-26.5% among women and 12.2%; 95% CI, 9.0%-16.4% among men) but was substantially lower than baseline (P < .001 for all). Weight loss was independently related to urinary incontinence remission (relative risk, 1.08; 95% CI, 1.06-1.10 in women and 1.07; 95% CI, 1.02-1.13 in men) per 5% weight loss, as were younger age and the absence of a severe walking limitation.Conclusions and relevanceAmong women and men with severe obesity, bariatric surgery was associated with substantially reduced urinary incontinence over 3 years. Improvement in urinary incontinence may be an important benefit of bariatric surgery.

Project description:BackgroundPelvic floor pressure distribution profiles, obtained by a novel instrumented non-deformable probe, were used as the input to a feature extraction, selection, and classification approach to test their potential for an automatic diagnostic system for objective female urinary incontinence assessment. We tested the performance of different feature selection approaches and different classifiers, as well as sought to establish the group of features that provides the greatest discrimination capability between continent and incontinent women.MethodsThe available data for evaluation consisted of intravaginal spatiotemporal pressure profiles acquired from 24 continent and 24 incontinent women while performing four pelvic floor maneuvers: the maximum contraction maneuver, Valsalva maneuver, endurance maneuver, and wave maneuver. Feature extraction was guided by previous studies on the characterization of pressure profiles in the vaginal canal, where the extracted features were tested concerning their repeatability. Feature selection was achieved through a combination of a ranking method and a complete non-exhaustive subset search algorithm: branch and bound and recursive feature elimination. Three classifiers were tested: k-nearest neighbors (k-NN), support vector machine, and logistic regression.ResultsOf the classifiers employed, there was not one that outperformed the others; however, k-NN presented statistical inferiority in one of the maneuvers. The best result was obtained through the application of recursive feature elimination on the features extracted from all the maneuvers, resulting in 77.1% test accuracy, 74.1% precision, and 83.3 recall, using SVM. Moreover, the best feature subset, obtained by observing the selection frequency of every single feature during the application of branch and bound, was directly employed on the classification, thus reaching 95.8% accuracy. Although not at the level required by an automatic system, the results show the potential use of pelvic floor pressure distribution profiles data and provide insights into the pelvic floor functioning aspects that contribute to urinary incontinence.

Project description:ImportanceSupervised pelvic floor muscle training (PFMT) has been recommended as the first-line treatment for women with stress urinary incontinence (SUI), but more evidence on whether adjunctive methods would provide additional benefits is needed.ObjectiveTo compare the efficacy of PFMT with or without a home-based pressure-mediated biofeedback (BF) device.Design, setting, and participantsThis multicenter assessor-blinded randomized clinical trial was conducted in the obstetric clinics of 5 participating tertiary hospitals in China. Participants included eligible women with new-onset postpartum SUI who were enrolled from March 28, 2022, to October 13, 2023.InterventionAll participants received 3 months of supervised PFMT and were randomized to either the intervention (PFMT with a home-based pressure-mediated BF device) or the control group (home-based PFMT).Main outcome and measuresThe primary outcome was the severity of urinary incontinence evaluated by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form after 3 months of supervised PFMT. The secondary outcomes included the cure and improvement rates, PFM strength, quality of life, self-efficacy, and adherence.ResultsA total of 452 participants (median age, 34 [IQR, 31-36] years; median body mass index [calculated as the weight in kilograms divided by the height in square meters], 23.71 [IQR, 21.37-25.97]; median time since delivery, 50 [IQR, 43-61] days) were included in the analysis, with 223 in the intervention group and 229 in the control group. Compared with the control group, the intervention group achieved a significantly greater reduction in incontinence severity (median, 3.00 [IQR, 1.00-6.00] vs 2.00 [IQR, 0-4.00] points; z = -3.05; P = .002), significantly increased cure rate (45 of 223 [20.2%] vs 20 of 229 [8.7%]; z = 12.02; P = .001) and improvement (132 of 223 [59.2%] vs 102 of 229 [44.5%]; z = 9.71; P = .002), significantly greater pelvic floor muscle strength (median, 26.00 [IQR, 17.00-38.00] vs 21.00 [IQR, 13.50-33.50] cm H2O; z = -2.28; P = .02), and a significantly greater correlation between subjective and objective adherence (r = 0.825 vs r = 0.627).Conclusion and relevanceIn this randomized clinical trial, the efficacy of pressure-mediated BF combined with PFMT was superior to that of PFMT alone. These findings support the use of pressure-mediated BF devices for improving treatment outcomes for patients with SUI.Trial registrationClinicalTrials.gov Identifier: NCT05115864.

Project description:BackgroundStress urinary incontinence (SUI) is a common condition that requires proper evaluation to select a personalized therapy. Vaginal Tactile Imaging (VTI) is a novel method to assess the biomechanical parameters of the pelvic floor.MethodsWomen with SUI were enrolled in this cross-sectional study. Participants completed the Medical, Epidemiologic, and Social Aspects of Aging (MESA) questionnaire and the Patient Global Impression of Severity Question (PGI-S) and underwent a VTI examination. Based on the MESA and PGI-S questionnaires, participants were divided into mild, moderate, and severe SUI groups. Fifty-two biomechanical parameters of the pelvic floor were measured by VTI and compared between the groups (mild vs. moderate and severe). SUI Score and Index were calculated from the MESA questionnaire. Pearson correlation was used to determine the strength of association between selected VTI parameters and the MESA SUI Index and MESA SUI Score.ResultsThirty-one women were enrolled into the study. Significant differences were observed in the VTI parameters 16, 22-24, 38, 39 when the difference between mild and severe subgroups of SUI based on the PGI-S score was examined. Parameter 16 refers to the maximum gradient at the perineal body, parameter 22-24 refers to the pressure response of the tissues behind the vaginal walls, and parameter 38, 39 refers the maximum pressure change and value on the right side at voluntary muscle contraction. VTI parameter 49, describing the displacement of the maximum pressure peak in the anterior compartment, showed a significant difference between the mild SUI and the moderate-severe SUI according to the MESA SUI score (mean ± SD 14.06 ± 5.16 vs. 7.54 ± 7.46, P = 0.04). The MESA SUI Index and SUI Score displayed a positive correlation concerning VTI parameters 4 (the maximum value of the posterior gradient) and 27 (the displacement of the maximum pressure peak in the anterior compartment) (VTI4 vs. MESA SUI Index r = 0.373, P = 0.039; VTI4 vs. MESA SUI Score r = 0.376, P = 0.037; VTI27 vs. MESA SUI Index r = 0.366, P = 0.043; VTI27 vs. MESA SUI Score r = 0.363, P = 0.044).ConclusionsFemale pelvic floor biomechanical parameters, as measured by VTI, correlate significantly with the severity of SUI and may help guide therapeutic decisions.

Project description:BackgroundPelvic floor muscle training is recommended as first line treatment for urinary incontinence in women based on three proposed theorized mechanisms: 'Enhanced Pelvic Floor Muscle Strength,' 'Maximized Awareness of Timing,' and 'Strengthened Core Muscles'. The purpose of this scoping review was to systematically map evidence for and against theorized mechanisms through which pelvic floor muscle training interventions work to reduce urinary incontinence in women.MethodsThe scoping review is based upon a comprehensive search of relevant literature published from 1990 to 2020 in PubMed, CINAHL, PsycINFO, ClinialTrials.gov, reference lists from review articles, and hand searches of articles by known researchers in the field. We included English-language, peer-reviewed articles on pelvic floor muscle training as an intervention for adult women if they provided empirical evidence to testing the theorized intervention mechanisms. Two independent reviewers screened articles for inclusion and extracted data to describe details of each study (author, year, country, design, sampling), measures of pelvic floor muscle strength and urinary incontinence, statistical analysis of linkage between changes in the measures, and pelvic floor muscle training regimens. Data were summarized to facilitate the integration of diverse evidence to draw conclusions on supporting or refuting the three proposed theorized mechanisms for managing urinary incontinence in women.ResultsOf the 278 articles identified with the search, 13 (4.7%) met inclusion criteria. There was weak to no evidence for the mechanism of enhanced pelvic floor muscle strength, equivocal support for maximized awareness of timing, and no evidence for strengthened core muscles.ConclusionsThis review revealed extremely limited data supporting the proposed theorized mechanisms underlying pelvic floor muscle training programs to manage urinary incontinence in women. Such evidence is needed to help women and clinicians understand how, why and when a woman benefits from pelvic floor muscle training. Future studies should specifically state and report statistical analysis that relates the theorized mechanisms to the training outcomes observed.

Dataset Information

Effect of pelvic floor muscle training on reports of urinary incontinence in obese women undergoing a low-calorie diet before bariatric surgery - protocol of a randomized controlled trial.

Background

Objective

Methods

Trial registration

Publications

Effect of pelvic floor muscle training on reports of urinary incontinence in obese women undergoing a low-calorie diet before bariatric surgery - protocol of a randomized controlled trial.

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