OPAL – Optimal PFMT for Adherence Long-term: Multicentre randomised trial of the effectiveness and cost-effectiveness of basic versus intensive, biofeedback-assisted pelvic floor muscle training for female stress or mixed urinary incontinence
Based on previous research, current UK guidelines recommend that women with stress incontinence are offered at least three months of pelvic floor muscle exercises. These exercises are taught by a specialist physiotherapist or nurse. There is evidence that these exercises can work to strengthen the muscles and decrease leakage, but it is not clear how ‘intensively’ women have to exercise to get a good result that lasts, thus improving their quality of life and reducing the likelihood of surgery. This research aims to find out whether the use of biofeedback can help to improve the results of the exercise training in both the short- and longer-term. We also want to find out how much urine leakage women in both groups have, how much this impacts on their lives, what other bladder problems they have, what other treatments they have had, how much exercise they did, how confident they were, and how much their muscles have strengthened. We also measure the costs of the treatments and any costs to the women and their families, and balance these costs against any benefits of the intensive treatment.
Outcome and Translation
Our aim is to establish if the addition of biofeedback to PFMT is more cost effective than PFMT alone. The results will inform the decision makers on the cost effectiveness of the addition of biofeedback machines to pelvic floor muscle training treatment of women with urinary incontinence.
HERU researchers involved in this research project: Mary Kilonzo
External collaborators: S Hagen, D McClurg, J Booth (Glasgow Caledonian University); C Glazener, J Francis, J Norrie, A Elders, A McDonald, G McPherson, N Kolehmainen (HSRU, University of Aberdeen); A Wael (NHS Ayrshire and Arran); M Abdel-Fattah (Other Applied Health Sciences, University of Aberdeen); C Bugge (University of Stirling); B Buckley (Independent); S Dean (University of Exeter); H Smith (University of Otago, NZ); KL Guerrero (clinical expert) and LE Wilson (User)
Further details are available on the OPAL project website.
International Standard Randomised Controlled Trial Number Register: ISRCTN57746448
Hagen, S., McClurg, D., Bugge, C., Hay-Smith, J., Dean, S.G., Elders, A., Glazener, C., Abdel-fattah, M., Agur, W.I., Booth, J., Guerrero, K., Norrie, J., Kilonzo, M., McPherson, G., McDonald, A., Stratton, S., Sergenson, N., Grant, A. and Wilson, L. (2019) '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', BMJ Open, 9(2), e024153.
Hagen, S., Bugge, C., Dean, S.G., Elders, A., Hay-Smith, J., Kilonzo, M., McClurg, D., Abdel-Fattah, M., Agur, W.I., Andreis, F., Booth, J., Dimitrova, M., Gillespie, N., Glazener, C., Grant, A., Guerrero, K., Henderson, L., Kovandzic, M., McDonald, A., Norrie, J., Sergenson, N., Stratton, S., Taylor, A. and Williams, L.R. (2019) Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT. Final project report to National Institute for Health Research (NIHR) Health Technology Assessment Programme (Project Number 11/71/03).
Hagen, S., Elders, A., Stratton, S., Sergenson, N., Bugge, C., Dean, S., Hay-Smith, J., Kilonzo, M., Dimitrova, M., Abdel-Fattah, M., Agur, W., Booth, J., Glazener, C., Guerrero, K., McDonald, A., Norrie, J., Williams, L. R. and McClurg, D. (2020) 'Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial', BMJ, 371, m3719.