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][797][798][799][800][801][802][803][804][805][806] Copyright © 2014 The Lancet Publishing Group A copy can be downloaded for personal non-commercial research or study, without prior permission or charge Content must not be changed in any way or reproduced in any format or medium without the formal permission of the copyright holder(s) Background Pelvic organ prolapse is common and is strongly associated with childbirth and increasing age. Women 8 with prolapse are often advised to do pelvic floor muscle exercises, but supporting evidence is limited. Our aim was to 9 establish if one--to--one individualised pelvic floor muscle training (PFMT) is effective in reducing prolapse symptoms. 11Methods A parallel--group multicentre randomised controlled trial (ISRCTN35911035) in female outpatients with 12 newly--diagnosed, symptomatic stage I, II or III prolapse, comparing five PFMT appointments over 16 weeks (n=225) 13 versus a lifestyle advice leaflet (n=222). Treatment allocation was by remote computer allocation using minimisation.14 Our primary endpoint was participants' self--report of prolapse symptoms at 12 months. Group assignment was 15 masked from outcome assessors. We compared outcomes between trial groups in an intention--to--treat analysis. The 16 cost of PFMT and savings on subsequent treatments were calculated to estimate cost--effectiveness. 18Findings Compared to the control group, the intervention group reported fewer prolapse symptoms at 12 months 19(mean difference between groups in change score 1. 27Interpretation One--to--one PFMT for prolapse is effective in improving prolapse symptoms. Longer--term benefits 28should be investigated, as should the effects in specific subgroups.
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