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Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial.

ABSTRACT: OBJECTIVE:To assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in women. DESIGN:Parallel group randomised controlled trial. SETTING:23 community and secondary care centres providing continence care in Scotland and England. PARTICIPANTS:600 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. INTERVENTIONS:Participants 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 MEASURES:The 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. RESULTS:Mean 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. CONCLUSIONS:At 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 REGISTRATION:ISRCTN57756448.

SUBMITTER: Hagen S

PROVIDER: S-EPMC7555069 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial.

Hagen Suzanne S Elders Andrew A Stratton Susan S Sergenson Nicole N Bugge Carol C Dean Sarah S Hay-Smith Jean J Kilonzo Mary M Dimitrova Maria M Abdel-Fattah Mohamed M Agur Wael W Booth Jo J Glazener Cathryn C Guerrero Karen K McDonald Alison A Norrie John J Williams Louise R LR McClurg Doreen D

BMJ (Clinical research ed.) 20201014

<h4>Objective</h4>To assess the effectiveness of pelvic floor muscle training (PFMT) plus electromyographic biofeedback or PFMT alone for stress or mixed urinary incontinence in women.<h4>Design</h4>Parallel group randomised controlled trial.<h4>Setting</h4>23 community and secondary care centres providing continence care in Scotland and England.<h4>Participants</h4>600 women aged 18 and older, newly presenting with stress or mixed urinary incontinence between February 2014 and July 2016: 300 we ...[more]

PMID: 33055247

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Project description:The aim of this study was to compare the effect of pelvic floor muscle training with surface electromyographic (sEMG) biofeedback (BF group) and Pilates exercises (P group) on the bioelectrical activity of pelvic floor muscles in women with stress urinary incontinence. The other aim aim was to compare changes in voiding diaries and scores on quality of life questionnaire against baseline values and between the groups. Women in the BF group (n = 18) participated in pelvic floor muscle training with sEMG biofeedback; the P group (n = 13) participated in basic level Pilates workouts. Both protocols were continued for eight weeks. Voiding diary, quality of life and electromyographic characteristics of the pelvic floor muscles were assessed at the three-time points: at baseline, after eight weeks' training, and at month six post-training. The sEMG activity of the pelvic floor muscles was tested during five trials in two positions. There was no marked improvement in bioelectrical activity of the pelvic floor muscles during contraction following training with sEMG biofeedback or Pilates exercises. Following eight weeks of sEMG biofeedback training, a decrease was noted in resting bioelectrical activity of pelvic floor muscles and during relaxation after sustained contraction but only in supine-lying. No such effect was observed in the Pilates group. In the BF group, the number of incontinence episodes after end of treatment (timpepoints: 1vs. 2) and at six month follow-up (timpepoints: 1vs. 3) decreased by 68.5% and 89.3%, respectively. The respective values in the P group were 78.6%, and 86.4%. The intergroup differences did not reach the level of statistical significance. As regards the quality of life, the questionnaire demonstrated that Pilates exercises had significantly better effects compared to biofeedback training both at the end of the eight-week exercise program and (p = 0.003) and at six month follow-up (p = 0.0009). The International Consultation on Incontinence Questionnaire-Short Form (ICIQ- SF) showed comparable efficacy of Pilates exercises and training with sEMG biofeedback. Intragroup improvements in micturition frequency, incontinence (leakage) episodes, and nocturia frequency were comparable. Alleviation of urinary incontinence symptoms was comparable in both groups, whereas the improvement in the quality of life was more notable in the Pilates group. The obtained results failed to demonstrate the superiority of any of the two methods regarding the bioelectrical activity of pelvic floor muscles in patients with stress urinary incontinence.

Project description:IntroductionAccidental urine leakage is a distressing problem that affects around one in three women. The main types of urinary incontinence (UI) are stress, urgency and mixed, with stress being most common. Current UK guidelines recommend that women with UI are offered at least 3?months of pelvic floor muscle training (PFMT). There is evidence that PFMT is effective in treating UI, however it is not clear how intensively women have to exercise to give the maximum sustained improvement in symptoms, and how we enable women to achieve this. Biofeedback is an adjunct to PFMT that may help women exercise more intensively for longer, and thus may improve continence outcomes when compared with PFMT alone. A Cochrane review was inconclusive about the benefit of biofeedback, indicating the need for further evidence.Methods and analysisThis multicentre randomised controlled trial will compare the effectiveness and cost-effectiveness of PFMT versus biofeedback-mediated PFMT for women with stress UI or mixed UI. The primary outcome is UI severity at 24 months after randomisation. The primary economic outcome measure is incremental cost per quality-adjusted life-year at 24 months. Six hundred women from UK community, outpatient and primary care settings will be randomised and followed up via questionnaires, diaries and pelvic floor assessment. All participants are offered six PFMT appointments over 16 weeks. The use of clinic and home biofeedback is added to PFMT for participants in the biofeedback group. Group allocation could not be masked from participants and healthcare staff. An intention-to-treat analysis of the primary outcome will estimate the mean difference between the trial groups at 24 months using a general linear mixed model adjusting for minimisation covariates and other important prognostic covariates, including the baseline score.Ethics and disseminationApproval granted by the West of Scotland Research Ethics Committee 4 (16/LO/0990). Written informed consent will be obtained from participants by the local research team. Serious adverse events will be reported to the data monitoring and ethics committee, the ethics committee and trial centres as required. A Standard Protocol Items: Recommendations for Interventional Trials checklist and figure are available for this protocol. The results will be published in international journals and included in the relevant Cochrane review.Trial registration numberISRCTN57746448; Pre-results.

Project description:UnlabelledWHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Stress urinary incontinence (SUI) affects 10-35% of women, and it is sometimes very distressful. Pelvic floor exercises are the first line of treatment, but access barriers or embarrassment may prevent women from seeking help. There is a need for new, simple, and effective ways to deliver treatment. Management of SUI without face-to-face contact is possible, and Internet-based treatment is a new, promising treatment alternative.ObjectiveTo compare two treatment programmes for stress urinary incontinence (SUI) without face-to-face contact: one Internet-based and one sent by post.Patients and methodsRandomised, controlled trial conducted in Sweden 2009-2011. Computer-generated block-randomisation, allocation by independent administrator. No 'blinding'. The study included 250 community-dwelling women aged 18-70 years, with SUI ≥1 time/week. Consecutive online recruitment. The women had 3 months of either; (i) An Internet-based treatment programme (124 women), including e-mail support and cognitive behavioural therapy assignments or (ii) A treatment programme sent by post (126). Both programmes focused mainly on pelvic floor muscle training.Primary outcomessymptom-score (International Consultation on Incontinence Questionnaire Short Form, ICIQ-UI SF) and condition-specific quality of life (ICIQ-Lower Urinary Tract Symptoms Quality of Life, ICIQ-LUTSQoL).Secondary outcomes(i) Patient Global Impression of Improvement, (ii) Incontinence aids, (iii) Patient satisfaction, (iv) Health-specific QoL (EQ5D-Visual Analogue Scale), and (v) Incontinence episode frequency. Follow-up after 4 months via self-assessed postal questionnaires.ResultsIn all, 12% (30 women) were lost to follow-up. Intention-to-treat analysis showed highly significant improvements (P < 0.001) with large effect sizes (>0.8) with both interventions, but there were no significant differences between groups in primary outcomes. The mean (sd) changes in symptom-score were: Internet 3.4 (3.4), Postal 2.9 (3.1) (P = 0.27). The mean (sd) changes in condition-specific QoL were: Internet 4.8 (6.1), Postal 4.6 (6.7) (P = 0.52). Compared with the postal-group, more participants in the Internet-group perceived they were much or very much improved (40.9% (43/105) vs 26.5% (30/113), P = 0.01), reported reduced usage of incontinence aids (59.5% (47/79) vs 41.4% (34/82), P = 0.02) and were satisfied with the treatment programme (84.8% (89/105) vs 62.9% (71/113), P < 0.001). Health-specific QoL improved in the Internet-group (mean change 3.7 (10.9), P = 0.001), but not in the postal-group (1.9 (13.0), P = 0.13). Overall, 69.8% (120/172) of participants reported complete lack of leakage or reduced number of leakage episodes by >50%.ConclusionsConcerning primary outcomes, treatment effects were similar between groups whereas for secondary outcomes the Internet-based treatment was more effective. Internet-based treatment for SUI is a new, promising treatment alternative.

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:Although behavioral therapy has been shown to improve postoperative recovery of continence, there have been no controlled trials of behavioral therapy for postprostatectomy incontinence persisting more than 1 year.To evaluate the effectiveness of behavioral therapy for reducing persistent postprostatectomy incontinence and to determine whether the technologies of biofeedback and pelvic floor electrical stimulation enhance the effectiveness of behavioral therapy.A prospective randomized controlled trial involving 208 community-dwelling men aged 51 through 84 years with incontinence persisting 1 to 17 years after radical prostatectomy was conducted at a university and 2 Veterans Affairs continence clinics (2003-2008) and included a 1-year follow-up after active treatment. Twenty-four percent of the men were African American; 75%, white.After stratification by type and frequency of incontinence, participants were randomized to 1 of 3 groups: 8 weeks of behavioral therapy (pelvic floor muscle training and bladder control strategies); behavioral therapy plus in-office, dual-channel electromyograph biofeedback and daily home pelvic floor electrical stimulation at 20 Hz, current up to 100 mA (behavior plus); or delayed treatment, which served as the control group.Percentage reduction in mean number of incontinence episodes after 8 weeks of treatment as documented in 7-day bladder diaries.Mean incontinence episodes decreased from 28 to 13 per week (55% reduction; 95% confidence interval [CI], 44%-66%) after behavioral therapy and from 26 to 12 (51% reduction; 95% CI, 37%-65%) after behavior plus therapy. Both reductions were significantly greater than the reduction from 25 to 21 (24% reduction; 95% CI, 10%-39%) observed among controls (P = .001 for both treatment groups). However, there was no significant difference in incontinence reduction between the treatment groups (P = .69). Improvements were durable to 12 months in the active treatment groups: 50% reduction (95% CI, 39.8%-61.1%; 13.5 episodes per week) in the behavioral group and 59% reduction (95% CI, 45.0%-73.1%; 9.1 episodes per week) in the behavior plus group (P = .32).Among patients with postprostatectomy incontinence for at least 1 year, 8 weeks of behavioral therapy, compared with a delayed-treatment control, resulted in fewer incontinence episodes. The addition of biofeedback and pelvic floor electrical stimulation did not result in greater effectiveness.clinicaltrials.gov Identifier: NCT00212264.

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Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial.

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Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial.

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