Efficacy of biofeedback, repetitive transcranial magnetic stimulation and pelvic floor muscle training for female neurogenic bladder dysfunction after spinal cord injury: a study protocol for a randomised controlled trial.
ABSTRACT: INTRODUCTION:Neurogenic bladder dysfunction is prevalent in female patients with spinal cord injury (SCI), and previous guidelines have recommended pelvic floor muscle training (PFMT) for first-line conservative treatment. However, the actual regimen of PFMT varies widely and the single treatment does not satisfy the need of some patients. Therefore, this study aims to provide a detailed rationale and methodology for comparing the effectiveness of PFMT, biofeedback and repetitive transcranial magnetic stimulation (rTMS) as adjunct treatments for neurogenic bladder dysfunction. METHODS AND ANALYSIS:This trial is a single-centre randomised controlled trial for female patients with urinary incontinence (UI) in phase of chronic SCI. Eligible participants will be randomised to one of four arms: (1) PFMT, (2) PFMT with biofeedback, (3) PFMT and rTMS and (4) PFMT with biofeedback and rTMS. There will be 44 participants in each arm and all the subjects will undergo 20 treatment sessions, five times a week for 4 weeks. The outcomes will be evaluated at 4 weeks, 3 months and 6 months after randomisation. The primary outcome is the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, and the secondary outcomes include bladder diary, pelvic floor muscle function and the International Spinal Cord Injury Quality of Life Basic Data Set. ETHICS AND DISSEMINATION:The Clinical Research and Biomedical Ethics Committee of the West China Hospital, Sichuan University has approved this trial and the approval number is 2019-885. All participants will be provided written informed consent after verification of the eligibility criteria. The results of this study will be accessible in peer-reviewed publications and be presented at academic conferences. TRIAL REGISTRATION NUMBER:Chinese Clinical Trial Registry (ChiCTR1900026126).
Project description: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.
Project description:Urge urinary incontinence is a major problem, especially in the elderly, and to our knowledge the underlying mechanisms of disease and therapy are unknown. We used biofeedback assisted pelvic floor muscle training and functional brain imaging (functional magnetic resonance imaging) to investigate cerebral mechanisms, aiming to improve the understanding of brain-bladder control and therapy.Before receiving biofeedback assisted pelvic floor muscle training functionally intact, older community dwelling women with urge urinary incontinence as well as normal controls underwent comprehensive clinical and bladder diary evaluation, urodynamic testing and brain functional magnetic resonance imaging. Evaluation was repeated after pelvic floor muscle training in those with urge urinary incontinence. Functional magnetic resonance imaging was done to determine the brain reaction to rapid bladder filling with urgency.Of 65 subjects with urge urinary incontinence 28 responded to biofeedback assisted pelvic floor muscle training with 50% or greater improvement of urge urinary incontinence frequency on diary. However, responders and nonresponders displayed 2 patterns of brain reaction. In pattern 1 in responders before pelvic floor muscle training the dorsal anterior cingulate cortex and the adjacent supplementary motor area were activated as well as the insula. After the training dorsal anterior cingulate cortex/supplementary motor area activation diminished and there was a trend toward medial prefrontal cortex deactivation. In pattern 2 in nonresponders before pelvic floor muscle training the medial prefrontal cortex was deactivated, which changed little after the training.In older women with urge urinary incontinence there appears to be 2 patterns of brain reaction to bladder filling and they seem to predict the response and nonresponse to biofeedback assisted pelvic floor muscle training. Moreover, decreased cingulate activation appears to be a consequence of the improvement in urge urinary incontinence induced by training while prefrontal deactivation may be a mechanism contributing to the success of training. In nonresponders the latter mechanism is unavailable, which may explain why another form of therapy is required.
Project description:INTRODUCTION:Accidental 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 ANALYSIS:This 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 DISSEMINATION:Approval 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 NUMBER:ISRCTN57746448; Pre-results.
Project description:AIMS:The primary aim is to provide detailed rationale and methodology for the development and implementation of a perioperative behavioral/pelvic floor exercise research protocol for women who self-chose surgical intervention and who may or may not have been offered behavioral treatments initially. This protocol is part of the ESTEEM trial (Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence Trial) which was designed to determine the effect of a combined surgical and perioperative behavioral/pelvic floor exercise intervention versus surgery alone on improving mixed urinary incontinence (MUI) and overactive bladder (OAB) symptoms. METHODS:As part of a multi-site, prospective, randomized trial of women with MUI electing midurethral sling (MUS) surgical treatment, participants were randomized to a standardized perioperative behavioral/pelvic floor exercise intervention?+?MUS versus MUS alone. The specific behavioral intervention included: education on voiding habits, pelvic floor muscle training (PFMT), bladder training (BT), strategies to control urgency and reduce/prevent urinary symptoms, and monitoring/promoting adherence to behavioral recommendations. To ensure consistency across all eight research sites in the pelvic floor disorders network (PFDN), selective behavioral treatments sessions were audiotaped and audited for protocol adherence. RESULTS:The behavioral intervention protocol includes individualization of interventions using an algorithm based on pelvic floor muscle (PFM) assessment, participant symptoms, and findings from the study visits. We present, here, the specific perioperative behavioral/pelvic floor exercise interventions administered by study interventionists. CONCLUSIONS:This paper details a perioperative behavioral/pelvic floor exercise intervention research study protocol developed for women undergoing surgery for MUI.
Project description:Importance:Urinary 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. Objective:To assess the efficacy of group-based PFMT relative to individual PFMT for urinary incontinence in older women. Design, Setting, and Participants:The 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. Interventions:After 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 Measures:The 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. Results:Among 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 Relevance:Results 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 Registration:ClinicalTrials.gov Identifier: NCT02039830.
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.
Project description:BACKGROUND:Stress urinary incontinence (SUI) is highly prevalent during pregnancy and after delivery. It is often associated with a failing pelvic floor, sphincteric and/or supportive system. Pelvic-floor-muscle training (PFMT) peri-partum has been proven effective for up to 1 year post-partum; however, its long-term effects are unknown. Group PFMT, given by a physiotherapist, has been proven to be as equally effective as individual therapy. Motherfit is a group-PFMT therapy with an emphasis on pelvic floor exercises, adherence and general fitness. Care-as-usual (CAU), if guideline driven, should, as first treatment option, consist of PFMT. Cost-effective strategies are of relevance, given the rise of health care costs. Motherfit group therapy has the potential to be cost-effective in women with urinary incontinence. Therefore, the objectives of the two current studies are: (1) to investigate whether intensive, supervised, pre-partum (MOTHERFIT1) or post-partum (MOTHERFIT2) pelvic-floor-muscle group therapy reduces 18-month post-partum severity of SUI compared to CAU and (2) whether MOTHERFIT1 OR MOTHERFIT 2 is more (cost-)effective compared to CAU. METHODS:Two multi-centred, randomised controlled trials (MOTHERFIT1, n =?150, MOTHERFIT2, n =?90) will be performed. Participants will be recruited by their midwife or gynaecologist during their routine check. Participants with SUI will receive either motherfit group therapy or CAU. Motherfit group therapy consists of eight group sessions of 60?min each, instructed and supervised by a registered pelvic physiotherapist. Motherfit group therapy includes instructions on pelvic floor anatomy and how to contract, relax and train the pelvic-floor muscles correctly and is combined with general physical exercises. Adherence during and after motherfit will be stimulated by reinforcement techniques and a mobile app. The primary outcome measure is the absence of self-reported SUI based on the severity sum score of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI-SF) at 18?months post-partum. Secondary outcomes evaluate quality of life, subjective improvement and health care costs. DISCUSSION:The motherfit studies are, to our knowledge, the first studies that evaluate both long-term results and health care costs compared to CAU in pregnant and post-partum women with SUI. If motherfit is shown to be (cost-)effective, implementation in peri-partum care should be considered. TRIAL REGISTRATION:Netherlands Trial Register, ID: NL5816 . Registered on 18 July 2016.
Project description:INTRODUCTION:Female urinary incontinence (UI) is common affecting up to 45% of women. Pelvic floor muscle training (PFMT) is the first-line treatment but there is uncertainty whether intensive PFMT is better than basic PFMT for long-term symptomatic improvement. It is also unclear which factors influence women's ability to perform PFMT long term and whether this has impacts on long-term outcomes. OPAL (optimising PFMT to achieve long-term benefits) trial examines the effectiveness and cost-effectiveness of basic PFMT versus biofeedback-mediated PFMT and this evaluation explores women's experiences of treatment and the factors which influence effectiveness. This will provide data aiding interpretation of the trial findings; make recommendations for optimising the treatment protocol; support implementation in practice; and address gaps in the literature around long-term adherence to PFMT for women with stress or mixed UI. METHODS AND ANALYSIS:This evaluation comprises a longitudinal qualitative case study and process evaluation (PE). The case study aims to explore women's experiences of treatment and adherence and the PE will explore factors influencing intervention effectiveness. The case study has a two-tailed design and will recruit 40 women, 20 from each trial group; they will be interviewed four times over 2 years. Process data will be collected from women through questionnaires at four time-points, from health professionals through checklists and interviews and by sampling 100 audio recordings of appointments. Qualitative analysis will use case study methodology (qualitative study) and the framework technique (PE) and will interrogate for similarities and differences between the trial groups regarding barriers and facilitators to adherence. Process data analyses will examine fidelity, engagement and mediating factors using descriptive and interpretative statistics. ETHICS AND DISSEMINATION:Approval from West of Scotland Research Ethics Committee 4 (16/LO/0990). Findings will be published in journals, disseminated at conferences and through the final report. TRIAL REGISTRATION NUMBER:ISRCTN57746448.
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:The goals of this trial are to determine the efficacy and safety of two treatments for women experiencing fecal incontinence. First, we aim to compare the use of loperamide to placebo and second, to compare the use of anal sphincter exercises with biofeedback to usual care. The primary outcome is the change from baseline in the St. Mark's (Vaizey) Score 24weeks after treatment initiation. As a Pelvic Floor Disorders Network (PFDN) trial, subjects are enrolling from eight PFDN clinical centers across the United States. A centralized data coordinating center supervises data collection and analysis. These two first-line treatments for fecal incontinence are being investigated simultaneously using a two-by-two randomized factorial design: a medication intervention (loperamide versus placebo) and a pelvic floor strength and sensory training intervention (anal sphincter exercises with manometry-assisted biofeedback versus usual care using an educational pamphlet). Interventionists providing the anal sphincter exercise training with biofeedback have received standardized training and assessment. Symptom severity, diary, standardized anorectal manometry and health-related quality of life outcomes are assessed using validated instruments administered by researchers masked to randomized interventions. Cost effectiveness analyses will be performed using prospectively collected data on care costs and resource utilization. This article describes the rationale and design of this randomized trial, focusing on specific research concepts of interest to researchers in the field of female pelvic floor disorders and all other providers who care for patients with fecal incontinence.