scholarly journals Effectiveness and cost-effectiveness randomised controlled trial of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence: protocol for the OPAL (optimising pelvic floor exercises to achieve long-term benefits) trial mixed methods longitudinal qualitative case study and process evaluation

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e024152 ◽  
Author(s):  
Aileen Grant ◽  
Sarah Dean ◽  
Jean Hay-Smith ◽  
Suzanne Hagen ◽  
Doreen McClurg ◽  
...  
Keyword(s):  
Urinary Incontinence ◽  
Cost Effectiveness ◽  
Pelvic Floor ◽  
Pelvic Floor Muscle Training ◽  
Qualitative Case Study ◽  
Pelvic Floor Muscle ◽  
Muscle Training ◽  
Process Data

IntroductionFemale 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 analysisThis 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 disseminationApproval 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 numberISRCTN57746448.

scholarly journals Effectiveness and cost-effectiveness of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence: protocol for the OPAL randomised trial

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e024153 ◽  
Author(s):  
Suzanne Hagen ◽  
Doreen McClurg ◽  
Carol Bugge ◽  
Jean Hay-Smith ◽  
Sarah Gerard Dean ◽  
...  
Keyword(s):  
Urinary Incontinence ◽  
Cost Effectiveness ◽  
Pelvic Floor ◽  
Primary Outcome ◽  
Pelvic Floor Muscle Training ◽  
Pelvic Floor Muscle ◽  
Randomised Trial ◽  
Cochrane Review ◽  
Ethics Committee ◽  
Muscle Training

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.

scholarly journals KEPT-app trial: a pragmatic, single-blind, parallel, cluster-randomised effectiveness study of pelvic floor muscle training among incontinent pregnant women: study protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e039076 ◽  
Author(s):  
Sherina Mohd Sidik ◽  
Aida Jaffar ◽  
Chai Nien Foo ◽  
Noor Azimah Muhammad ◽  
Rosliza Abdul Manaf ◽  
...  
Keyword(s):  
Urinary Incontinence ◽  
Cost Effectiveness ◽  
Pelvic Floor ◽  
Pregnant Women ◽  
Pelvic Floor Muscle Training ◽  
Pelvic Floor Muscle ◽  
Ethics Committee ◽  
Muscle Training ◽  
Cluster Randomised ◽  
Secondary Outcomes

IntroductionPelvic floor muscle training (PFMT) strongly recommended to incontinent pregnant women. The Kegel Exercise Pregnancy Training-app trial is a multicentre cluster-randomised study aims to assess the effectiveness and its cost-effectiveness of the mobile app guidance in PFMT among incontinent pregnant women.Methods and analysis370 pregnant women (aged 18 years old and above) will be recruited with International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form. Ten clusters (primary care clinics) will be randomly assigned to either PFMT or usual care in a 1:1 ratio by an independent researcher (sealed envelope). The primary outcome will be urinary incontinence, and the secondary outcomes (quality of life; PFMT adherence, psychological status and mobile apps’ usability) will be assessed at four measurement time points (t0: baseline) and postintervention (t1: 4 weeks, t2: 8 weeks and t3: 8 weeks postnatal). T-test analysis will determine any significant differences at the baseline between the control and intervention groups. The mixed-model analysis will determine the effectiveness of the intervention at the population-average level for both the primary and secondary outcomes. For the cost-effectiveness analysis, expenditures during the study and 6 months after the intervention will be compared between the groups using the multiway sensitivity analysis. The recruitment planned will be in December 2020, and the planned end of the study will be in August 2021.Ethics and disseminationThis study protocol was approved by the Ethics Committee for Research Involving Human Subjects, Universiti Putra Malaysia (JKEUPM-2019–368) and Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia, NMRR-19-412-47116 (IIR) with the ANZCTR registration. This study will obtain informed written consent from all the study participants. The results which conform with the Consolidated Standards of Reporting Trials and the Recommendations for Interventional Trials will be published for dissemination in peer-reviewed journals and conference proceedings.Trial registration numberACTRN12619000379112.

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