Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT

Suzanne Hagen, Carol Bugge, Sarah G Dean, Andrew Elders, Jean Hay-Smith, Mary Kilonzo, Doreen McClurg, Mohamed Abdel-Fattah, Wael Agur, Federico Andreis, Jo Booth, Maria Dimitrova, Nicola Gillespie, Cathryn M.A. Glazener, Aileen Grant, Karen L Guerrero, Lorna Henderson, Marija Kovandzic, Alison McDonald, John NorrieNicole Sergenson, Susan Stratton, Anne Taylor, Louise Williams

Research output: Contribution to journalArticlepeer-review


Urinary incontinence (accidental leakage of urine) is a common and embarrassing problem for women. Pregnancy and childbirth may contribute by leading to less muscle support and bladder control. Pelvic floor exercises and ‘biofeedback’ equipment (a device that lets women see the muscles working as they exercise) are often used in treatment. There is good evidence that exercises (for the pelvic floor) can help, but less evidence about whether or not adding biofeedback provides better results. This trial compared pelvic floor exercises alone with pelvic floor exercises plus biofeedback. Six hundred women with urinary incontinence participated. Three hundred women were randomly assigned to the exercise group and 300 women were randomised to the exercise plus biofeedback group. Each woman had an equal chance of being in either group. Women were offered six appointments with a therapist over
16 weeks to receive their allocated treatment. After 2 years, there was no difference between the groups in the severity of women’s urinary incontinence.
Women in both groups varied in how much exercise they managed to do. Some managed to exercise consistently over the 2 years and others less so. There were many factors (other than the treatment received) that affected a woman’s ability to exercise. Notably, women viewed the therapists’ input very positively.
The therapists reported some problems fitting biofeedback into the appointments, but, overall, they delivered both treatments as intended. Women carried out exercises at home and many in the biofeedback pelvic floor
muscle training group also used biofeedback at home; however, for both groups, time issues, forgetting and other health problems affected their adherence. There were no serious complications related to either treatment. Overall, exercise plus biofeedback was not significantly more expensive than exercise alone and the quality of life associated with exercise plus biofeedback was not better than the quality of life for exercise alone. In summary, exercises plus biofeedback was no better than exercise alone. The findings do not support
using biofeedback routinely as part of pelvic floor exercise treatment for women with urinary incontinence.
Original languageEnglish
Number of pages168
JournalHealth Technology Assessment
Publication statusAccepted/In press - 20 May 2019


  • incontinence
  • biofeedback
  • pelvic floor muscle training

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