Individualised pelvic floor muscle training in women with pelvic organ prolapse: a multicentre randomised controlled trial

Hagen, S. et al. (2014) Individualised pelvic floor muscle training in women with pelvic organ prolapse: a multicentre randomised controlled trial. Lancet, 383(9919), pp. 796-806. (doi:10.1016/S0140-6736(13)61977-7)

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Abstract

<br>Background: Pelvic organ prolapse is common and is strongly associated with childbirth and increasing age. Women with prolapsed are often advised to do pelvic floor muscle exercises, but supporting evidence is limited. Our aim was to establish if one-to-one individualised pelvic floor muscle training (PFMT) is effective in reducing prolapse symptoms.</br> <br>Methods: A parallel‐group multicentre randomised controlled trial (ISRCTN35911035) in female outpatients with newly-diagnosed, symptomatic stage I, II or III prolapse, comparing five PFMT appointments over 16 weeks (n=225) versus a lifestyle advice leaflet (n=222). Treatment allocation was by remote computer allocation using minimisation. Our primary endpoint was participants’ self-report of prolapsed symptoms at 12 months. Group assignment was masked from outcome assessors. We compared outcomes between trial groups in an intention-to-treat analysis. The cost of PFMT and savings on subsequent treatments were calculated to estimate cost-effectiveness.</br> <br>Findings: Compared to the control group, the intervention group reported fewer prolapse symptoms at 12 months (mean difference between groups in change score 1.52, 95% CI [0.46, 2.59], p=0.0053); reported their prolapse to be “better” more often (57.2% versus 44.7%, difference 12.6%, 95% CI [1.1%, 24.1%], p=0.0336); and had an increased but non-significant odds of having less severe stage of prolapse at their 6-month clinical examination, (OR 1.47, 95% CI [0.97, 2.27], p=0.07). The control group had a greater uptake of other prolapse treatment (49.6% versus 24.1%, difference 25.5%, 95% CI [14.5%, 36.0%], p <0.0001). Findings were robust to missing data. The net cost of the 25 intervention was £131.61 per woman and the cost per one-point reduction in the symptom score was £86.59, 95% CI [£50.81, £286.11]. </br>

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Walker, Dr Andrew and Barry, Dr Sarah
Authors: Hagen, S., Stark, D., Glazener, C., Dickson, S., Barry, S., Elders, A., Frawley, H., Galea, M.P., Logan, J., McDonald, A., McPherson, G., Moore, K.H., Norrie, J., Walker, A., and Wilson, D.
College/School:College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Robertson Centre
Journal Name:Lancet
Publisher:The Lancet Publishing Group
ISSN:0140-6736
ISSN (Online):1474-547X
Copyright Holders:Copyright © 2014 The Lancet Publishing Group
First Published:First published in The Lancet 383(9919):796-806
Publisher Policy:Reproduced in accordance with the copyright policy of the publisher.

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