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.

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.

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.

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.

ISRCTN57746448; Pre-results.

BMJ open. 2019 Feb 19*** epublish ***

Suzanne Hagen, Doreen McClurg, Carol Bugge, Jean Hay-Smith, Sarah Gerard Dean, Andrew Elders, Cathryn Glazener, Mohamed Abdel-Fattah, Wael Ibrahim Agur, Jo Booth, Karen Guerrero, John Norrie, Mary Kilonzo, Gladys McPherson, Alison McDonald, Susan Stratton, Nicole Sergenson, Aileen Grant, Lyndsay Wilson

Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK., Faculty of Health Sciences and Sport, University of Stirling, Stirling, UK., Department of Medicine, University of Otago, Dunedin, New Zealand., Medical School, University of Exeter, Exeter, UK., Health Services Research Unit, University of Aberdeen, Aberdeen, UK., Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK., Department of Obstetrics and Gynaecology, NHS Ayrshire and Arran University Hospital Crosshouse, Kilmarnock, UK., School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK., Department of Gynaecology, NHS Greater Glasgow and Clyde, Glasgow, UK., Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK., Health Economics Research Unit, University of Aberdeen, Aberdeen, UK., The Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, Aberdeen, UK., School of Nursing and Midwifery, Robert Gordon University, Aberdeen, UK., Consumer Representative, Ayrshire, UK.