Multicentre randomised trial of the effectiveness and cost-effectiveness of basic versus biofeedback-mediated intensive pelvic floor muscle training for female stress or mixed urinary incontinence (OPAL-Optimal PFMT for Adherence Long-term) (Phase III)

Aim(s):

To establish if a PFMT regimen intensified via the addition of a theory-based biofeedback protocol, compared to basic PFMT, is more effective and cost-effective in reducing severity of urinary incontinence (UI) at 24 months, and providing greater improvement in quality of life, reduced need for surgery and other UI treatment, improved pelvic floor muscle function and increased self-efficacy for, and adherence to, PFMT.

Summary:

Based on past research, current UK guidelines recommend that women with stress incontinence are offered at least three months of pelvic floor muscle exercises. The exercises are taught by a specialist physiotherapist or nurse. There is evidence that these exercises can strengthen the muscles and decrease leakage. It is not clear how "intensively" women have to exercise to get a good result that lasts, thus improving the woman's quality of life and reducing the likelihood of surgery.

This multicentre trial aims to find out whether the use of biofeedback can help to improve the results of pelvic floor muscle exercises in 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 about exercising and how much their muscles have strengthened. We will also measure the costs of the treatments and any costs to the woman and her family, and balance these against any benefits of the intensive treatment.

Across 23 UK centres, 600 women with stress or mixed UI have now been randomised to either basic PFMT or biofeedback intensified PFMT. The primary outcome is severity of UI at 24 months, measured using the ICIQ-UI score via participant-completed questionnaire. A process evaluation, interview study and health economic evaluation are also being conducted.

Principal Investigator: Professor Suzanne Hagen

NMAHP Research Unit Collaborators: Andy Elders, Professor Doreen McClurg

External Collaborators: Abdel-Fattah M, Agur W, Booth J, Bugge C, Buckley B, Dean S, Glazener C, Guerrero K, Hay-Smith J, Kilonzo M, McDonald A, McPherson G, Norrie J, Wilson L.

Funder: NIHR