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Urology
Protocol
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
  1. Aileen Grant1,
  2. Sarah Dean2,
  3. Jean Hay-Smith3,
  4. Suzanne Hagen4,
  5. Doreen McClurg4,
  6. Anne Taylor5,
  7. Marija Kovandzic5,
  8. Carol Bugge5
  1. 1 School of Nursing and Midwifery, Robert Gordon University, Aberdeen, UK
  2. 2 South West Peninsula Collaboration for Leadership in Applied Research in Health Care (PenCLAHRC), University of Exeter, Exeter, UK
  3. 3 Rehabilitation Teaching and Research Unit, University of Otago, Wellington, New Zealand
  4. 4 Nursing Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK
  5. 5 Faculty of Health Sciences and Sport, University of Stirling, Stirling, UK
  1. Correspondence to Dr Aileen Grant; a.grant17{at}rgu.ac.uk

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.

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

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2018-024152

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    Footnotes

    • Patient consent for publication Not required.

    • Contributors CB, SGD, JH-S: involved in the initial conceptualisation and study design. AG and AT: involved with participants and data collection. CB, SGD, AG, JH-S, MK and AT: involved in data analysis. SH: is the PI and along with DMcC advise on interpretation of the data in light of the trial results. AG: wrote the paper. All authors contributed to, read and approved the final manuscript. CB: is responsible for this manuscript.

    • Funding This project, Optimising Pelvic floor Exercises to Achieve Long-term benefits (OPAL) is funded by the NIHR Health Technology Assessment Programme (project reference: 11/71/03).

    • Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

    • Competing interests None declared.

    • Ethics approval The West of Scotland Research Ethics Committee 4 (6/LO/0990).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Technical appendix, statistical code, and datasets (subject to agreement with the TSC and funders) will be made available at the end of the trial.

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