Hagen S, Bugge C, Dean SG, Elders A, Hay-Smith J, Kilonzo M, McClurg D, Abdel-Fattah M, Agur W, Andreis F, Booth J, Dimitrova M, Gillespie N, Kovandzic M & Taylor A (2020) Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT. Health Technology Assessment, 24 (70), pp. 1-144. https://doi.org/10.3310/hta24700
Urinary incontinence affects one in three women worldwide. Pelvic floor muscle training is an effective treatment. Electromyography biofeedback (providing visual or auditory feedback of internal muscle movement) is an adjunct that may improve outcomes.
To determine the clinical effectiveness and cost-effectiveness of biofeedback-mediated intensive pelvic floor muscle training (biofeedback pelvic floor muscle training) compared with basic pelvic floor muscle training for treating female stress urinary incontinence or mixed urinary incontinence.
A multicentre, parallel-group randomised controlled trial of the clinical effectiveness and cost-effectiveness of biofeedback pelvic floor muscle training compared with basic pelvic floor muscle training, with a mixed-methods process evaluation and a longitudinal qualitative case study. Group allocation was by web-based application, with minimisation by urinary incontinence type, centre, age and baseline urinary incontinence severity. Participants, therapy providers and researchers were not blinded to group allocation. Six-month pelvic floor muscle assessments were conducted by a blinded assessor.
This trial was set in UK community and outpatient care settings.
Women aged ≥ 18 years, with new stress urinary incontinence or mixed urinary incontinence. The following women were excluded: those with urgency urinary incontinence alone, those who had received formal instruction in pelvic floor muscle training in the previous year, those unable to contract their pelvic floor muscles, those pregnant or
Additional co-authors: Cathryn Glazener, Aileen Grant, Karen L Guerrero, Lorna Henderson, Alison McDonald, John Norrie, Nicole Sergenson, Susan Stratton, Louise R Williams
Health Technology Assessment: Volume 24, Issue 70
|Publication date online||31/12/2020|
|Date accepted by journal||01/05/2019|
|Publisher||National Institute for Health Research|