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

Aileen Grant, Suzanne Hagen, Sarah Dean, Jean Hay-Smith, Doreen McClurg, Anne Taylor, Marija Kovandzic, Carol Bugge

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Abstract

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.
Original languageEnglish
Pages (from-to)e024152
JournalBMJ Open
Volume9
Issue number2
DOIs
Publication statusPublished - 8 Feb 2019

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Pelvic Floor
Urinary Incontinence
Cost-Benefit Analysis
Randomized Controlled Trials
Exercise
Muscles
OPAL protocol
Research Ethics Committees
Scotland
Clinical Protocols
Checklist
Ethics
Uncertainty
Appointments and Schedules
Therapeutics
Interviews
Health

Keywords

  • urinary incontinence, pelvic floor muscle training, biofeedback, process evaluation, qualitative, comparative case study

Cite this

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title = "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",
abstract = "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.",
keywords = "urinary incontinence, pelvic floor muscle training, biofeedback, process evaluation, qualitative, comparative case study",
author = "Aileen Grant and Suzanne Hagen and Sarah Dean and Jean Hay-Smith and Doreen McClurg and Anne Taylor and Marija Kovandzic and Carol Bugge",
note = "Acceptance in SAN OA article",
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T1 - 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

AU - Grant, Aileen

AU - Hagen, Suzanne

AU - Dean, Sarah

AU - Hay-Smith, Jean

AU - McClurg, Doreen

AU - Taylor, Anne

AU - Kovandzic, Marija

AU - Bugge, Carol

N1 - Acceptance in SAN OA article

PY - 2019/2/8

Y1 - 2019/2/8

N2 - 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.

AB - 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.

KW - urinary incontinence, pelvic floor muscle training, biofeedback, process evaluation, qualitative, comparative case study

U2 - 10.1136/bmjopen-2018-024152

DO - 10.1136/bmjopen-2018-024152

M3 - Article

C2 - 30782894

VL - 9

SP - e024152

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 2

ER -