Project description:BackgroundPelvic floor muscle training is the most commonly used physical therapy treatment for women with urinary incontinence.ObjectivesTo assess the effects of Pelvic floor muscle training for women with urinary incontinence in comparison to a control treatment and to summarize relevant economic findings.MethodsCochrane Incontinence Group Specialized Register (February 12, 2018).Selection criteriaRandomized or quasi-randomized trials in women with stress, urgency or mixed urinary incontinence (symptoms, signs, or urodynamic).Data collection and analysisTrials were independently assessed by at least two reviewers authors and subgrouped by urinary incontinence type. Quality of evidence was assessed by adopting the Grading of Recommendations, Assessment, Development and Evaluation approach.ResultsThe review included thirty-one trials involving 1817 women from 14 countries. Overall, trials were small to moderate size, and many were at moderate risk of bias. There was considerable variation in the intervention's content and duration. Based on data available, we can be confident that Pelvic floor muscle training can cure or improve symptoms of stress and all other types of urinary incontinence. It may reduce the number of leakage episodes and the quantity of leakage, while improving reported symptoms and quality of life. Women were more satisfied with Pelvic floor muscle training, while those in control groups were more likely to seek further treatment. Long-term effectiveness and cost-effectiveness of Pelvic floor muscle training needs to be further researched.ConclusionsThe addition of ten new trials did not change the essential findings of the earlier review, suggesting that Pelvic floor muscle training could be included in first-line conservative management of women with urinary incontinence.
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.
Project description:BackgroundIn women with mixed urinary incontinence, pelvic floor muscle training and solifenacin is the recommended conservative treatment, while electroacupuncture is a safe, economical and effective option.Methods/designIn this prospective, multi-center, randomized controlled trial, five hundred women with mixed urinary incontinence, from 10 centers will be randomized to receive either electroacupuncture or pelvic floor muscle training plus solifenacin. Women in the acupuncture group will receive electroacupuncture for 3 sessions per week, over 12 weeks, while women in the control group will receive pelvic floor muscle training plus solifenacin (5 mg once daily) for 36 weeks. The primary outcome measure is the proportion of change in 72-hour incontinence episode frequency from baseline to week 12. The secondary outcome measures include eleven items, including proportion of participants with ≥50% decrease in average 72-h incontinence episode frequency, change from baseline in the amount of urine leakage and proportion of change from baseline in 72-h incontinence episode frequency in week 25-36, and so forth. Statistical analysis will include covariance analysis, nonparametric tests and t tests.DiscussionThe objective of this trial is to compare the efficacy and safety of electroacupuncture versus pelvic floor muscle training plus solifenacin in women with moderate and severe mixed urinary incontinence.Trial registrationClinicalTrials.gov Identifier: NCT02047032.
Project description:Introduction and hypothesisThe aim of this study was to prospectively identify aspects of baseline demographic, clinical, and pelvic morphology of women with stress urinary incontinence (SUI) that are predictive of cure with physiotherapist-supervised pelvic floor muscle training (PFMT).MethodsWomen ≥18 years old with SUI were recruited from urogynecology and pelvic health physiotherapy clinics. Participants completed a 3-day bladder diary, the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF), a standardized pad test, manual assessment of pelvic floor muscle (PFM) strength and tone, and transperineal ultrasound (TPUS) assessment of their urogenital structures at rest while in a supine position and standing, and during contraction, straining, and coughing. Participants attended six physiotherapy sessions over 12 weeks and performed a home PFMT program. The assessment was repeated after the intervention; cure was defined as a dry (≤2 g) pad test.ResultsSeventy-seven women aged 50 (±10) years completed the protocol; 38 (49%) were deemed cured. Based on univariate testing, four predictors were entered into a binary logistic regression model: ICIQ-UI-SF, PFM tone, bladder neck (BN) height in a quiet standing position, and BN height during a cough in a standing position. The model was significant (p < 0.001), accurately classifying outcome in 74% of participants. The model, validated through bootstrapping, performed moderately, with the area under the receiver operating characteristic curve = 0.80 (95% CI: 0.69-0.90; p = 0.00), and with 70% sensitivity and 75% specificity.ConclusionsWomen with better bladder support in a standing position and less severe symptoms were most likely to be cured with PFMT.Clinical trial registration#NCT01602107.
Project description:BackgroundStress urinary incontinence (SUI) is a prevalent and costly condition which may be treated surgically or by physical therapy. The aim of this review was to systematically assess the literature and present the best available evidence for the efficacy and effectiveness of pelvic floor muscle training (PFMT) performed alone and together with adjunctive therapies (eg biofeedback, electrical stimulation, vaginal cones) for the treatment of female SUI.MethodsAll major electronic sources of relevant information were systematically searched to identify peer-reviewed English language abstracts or papers published between 1995 and 2005. Randomised controlled trials (RCTs) and other study designs eg non-randomised trials, cohort studies, case series, were considered for this review in order to source all the available evidence relevant to clinical practice. Studies of adult women with a urodynamic or clinical diagnosis of SUI were eligible for inclusion. Excluded were studies of women who were pregnant, immediately post-partum or with a diagnosis of mixed or urge incontinence. Studies with a PFMT protocol alone and in combination with adjunctive physical therapies were considered. Two independent reviewers assessed the eligibility of each study, its level of evidence and the methodological quality. Due to the heterogeneity of study designs, the results are presented in narrative format.ResultsTwenty four studies, including 17 RCTs and seven non-RCTs, met the inclusion criteria. The methodological quality of the studies varied but lower quality scores did not necessarily indicate studies from lower levels of evidence. This review found consistent evidence from a number of high quality RCTs that PFMT alone and in combination with adjunctive therapies is effective treatment for women with SUI with rates of 'cure' and 'cure/improvement' up to 73% and 97% respectively. The contribution of adjunctive therapies is unclear and there is limited evidence about treatment outcomes in primary care settings.ConclusionThere is strong evidence for the efficacy of physical therapy for the treatment for SUI in women but further high quality studies are needed to evaluate the optimal treatment programs and training protocols in subgroups of women and their effectiveness in clinical practice.
Project description:ImportanceUrinary incontinence is one of the most prevalent health concerns experienced by older women (aged ≥60 years). Individual pelvic floor muscle training (PFMT) is the recommended first-line treatment for stress or mixed urinary incontinence in women, but human and financial resources limit its delivery. Whether group-based PFMT performs as well as individual PFMT in this population remains unclear.ObjectiveTo assess the efficacy of group-based PFMT relative to individual PFMT for urinary incontinence in older women.Design, setting, and participantsThe Group Rehabilitation or Individual Physiotherapy (GROUP) study is a single-blind, randomized, noninferiority trial conducted in 2 Canadian research centers, from July 1, 2012, to June 2, 2018. A total of 362 community-dwelling women aged 60 years or older with symptoms of stress or mixed urinary incontinence were enrolled.InterventionsAfter an individual session conducted to learn how to contract pelvic floor muscles, participants completed 12-week PFMT as part of a group of 8 women (n = 178) or in individual sessions (n = 184).Main outcomes and measuresThe primary outcome measure was the percentage reduction in urinary incontinence episodes at 1 year, as reported in a 7-day bladder diary and relative to pretreatment baseline. Secondary outcomes included lower urinary tract-related signs, symptoms, and quality of life immediately following treatment and at 1 year. Per-protocol analysis was used.ResultsAmong 362 women who were randomized (mean [SD] age, 67.9 [5.8] years), 319 women (88%) completed the 1-year follow-up and were included in the per-protocol analysis. Median percentage reduction in urinary incontinence episodes was 70% (95% CI, 44%-89%) in individual PFMT compared with 74% (95% CI, 46%-86%) in group-based PFMT. The upper boundary of the 95% CI for the difference in the percentage reduction in urinary incontinence episodes at 1 year was lower than the prespecified margin for noninferiority of 10% (difference, 4%; 95% CI, -10% to 7%; P = .58), confirming noninferiority. Individual PFMT and group-based PFMT had similar effectiveness for all secondary outcomes at 1 year. Adverse events were minor and uncommon.Conclusions and relevanceResults of the GROUP study suggest that group-based PFMT is not inferior to the recommended individual PFMT for the treatment of stress and mixed urinary incontinence in older women. Widespread use in clinical practice may help increase continence-care affordability and treatment availability.Trial registrationClinicalTrials.gov Identifier: NCT02039830.
Project description:Pelvic floor muscle training is effective and recommended as first-line therapy for female patients with stress urinary incontinence. However, standard pelvic floor physiotherapy concentrates on voluntary contractions even though the situations provoking stress urinary incontinence (for example, sneezing, coughing, running) require involuntary fast reflexive pelvic floor muscle contractions. Training procedures for involuntary reflexive muscle contractions are widely implemented in rehabilitation and sports but not yet in pelvic floor rehabilitation. Therefore, the research group developed a training protocol including standard physiotherapy and in addition focused on involuntary reflexive pelvic floor muscle contractions.The aim of the planned study is to compare this newly developed physiotherapy program (experimental group) and the standard physiotherapy program (control group) regarding their effect on stress urinary incontinence. The working hypothesis is that the experimental group focusing on involuntary reflexive muscle contractions will have a higher improvement of continence measured by the International Consultation on Incontinence Modular Questionnaire Urinary Incontinence (short form), and - regarding secondary and tertiary outcomes - higher pelvic floor muscle activity during stress urinary incontinence provoking activities, better pad-test results, higher quality of life scores (International Consultation on Incontinence Modular Questionnaire) and higher intravaginal muscle strength (digitally tested) from before to after the intervention phase. This study is designed as a prospective, triple-blinded (participant, investigator, outcome assessor), randomized controlled trial with two physiotherapy intervention groups with a 6-month follow-up including 48 stress urinary incontinent women per group. For both groups the intervention will last 16 weeks and will include 9 personal physiotherapy consultations and 78 short home training sessions (weeks 1-5 3x/week, 3x/day; weeks 6-16 3x/week, 1x/day). Thereafter both groups will continue with home training sessions (3x/week, 1x/day) until the 6-month follow-up. To compare the primary outcome, International Consultation on Incontinence Modular Questionnaire (short form) between and within the two groups at ten time points (before intervention, physiotherapy sessions 2-9, after intervention) ANOVA models for longitudinal data will be applied.This study closes a gap, as involuntary reflexive pelvic floor muscle training has not yet been included in stress urinary incontinence physiotherapy, and if shown successful could be implemented in clinical practice immediately.NCT02318251 ; 4 December 2014 First patient randomized: 11 March 2015.
Project description:ObjectiveTo assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in women.DesignParallel group randomised controlled trial.Setting23 community and secondary care centres providing continence care in Scotland and England.Participants600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300 were randomised to PFMT plus electromyographic biofeedback and 300 to PFMT alone.InterventionsParticipants in both groups were offered six appointments with a continence therapist over 16 weeks. Participants in the biofeedback PFMT group received supervised PFMT and a home PFMT programme, incorporating electromyographic biofeedback during clinic appointments and at home. The PFMT group received supervised PFMT and a home PFMT programme. PFMT programmes were progressed over the appointments.Main outcome measuresThe primary outcome was self-reported severity of urinary incontinence (International Consultation on Incontinence Questionnaire-urinary incontinence short form (ICIQ-UI SF), range 0 to 21, higher scores indicating greater severity) at 24 months. Secondary outcomes were cure or improvement, other pelvic floor symptoms, condition specific quality of life, women's perception of improvement, pelvic floor muscle function, uptake of other urinary incontinence treatment, PFMT self-efficacy, adherence, intervention costs, and quality adjusted life years.ResultsMean ICIQ-UI SF scores at 24 months were 8.2 (SD 5.1, n=225) in the biofeedback PFMT group and 8.5 (SD 4.9, n=235) in the PFMT group (mean difference -0.09, 95% confidence interval -0.92 to 0.75, P=0.84). Biofeedback PFMT had similar costs (mean difference £121 ($154; €133), -£409 to £651, P=0.64) and quality adjusted life years (-0.04, -0.12 to 0.04, P=0.28) to PFMT. 48 participants reported an adverse event: for 23 this was related or possibly related to the interventions.ConclusionsAt 24 months no evidence was found of any important difference in severity of urinary incontinence between PFMT plus electromyographic biofeedback and PFMT alone groups. Routine use of electromyographic biofeedback with PFMT should not be recommended. Other ways of maximising the effects of PFMT should be investigated.Trial registrationISRCTN57756448.