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.

There is now some evidence available indicating a positive effect of PFMT for prolapse symptoms and severity. The largest most rigorous trial to date suggests that six months of supervised PFMT has benefits in terms of anatomical and symptom improvement (if symptomatic) immediately post-intervention. Further evidence relating to effectiveness and cost-effectiveness of PFMT, of different intensities, for symptomatic prolapse in the medium and long term is needed. A large trial of PFMT supplementing surgery is needed to give clear evidence about the usefulness of combining these treatments. Other comparisons which have not been addressed in trials to date and warrant consideration include those involving lifestyle change interventions, and trials aimed at prolapse prevention.

Given the lack of high-quality studies, the conclusions were informed by expert opinion. Adherence is central to short- and longer-term PFMT effect. More attention and explicit reporting is needed regarding: (1) applying health behavior theory in PFMT program planning; (2) identifying adherence determinants; (3) developing and implementing interventions targeting known adherence determinants; (4) using patient-centred approaches to evaluating adherence barriers and facilitators; (5) measuring adherence, including refining and testing instruments; and (6) testing the association between adherence and PFMT outcome.

Objective To assess the internal consistency, construct validity and sensitivity to change of a pelvic organ prolapse symptom score (POP-SS).Design Analysis of data from three prolapse studies, including symptomatic and asymptomatic women who completed the POP-SS.Setting (1) A community setting in New Zealand, (2) two gynaecology outpatient departments in Scotland and (3) a gynaecological surgery department in Scotland.Population or sample (1) Participants from a survey of postnatal women at 12-year follow up, invited to complete a prolapse questionnaire and have prolapse assessment, (2) new gynaecology outpatients presenting with prolapse symptoms, randomised to pelvic floor muscle training (PFMT) or control and (3) women having anterior and/or posterior prolapse surgery, randomised to mesh insert or no mesh.Method Data were analysed to assess internal consistency, construct validity and sensitivity to change of the POP-SS.Main outcome measures Cronbach's alpha, significance of differences in POP-SS scores between studies and significance of difference in POP-SS scores pre-to post-intervention.Results For internal consistency, Cronbach's alpha ranged from 0.723 to 0.828. Women having surgery had higher POP-SS scores than those having conservative management (mean difference 5.0, 95% CI 3.1-6.9), who in turn had higher scores than the asymptomatic women (mean difference 5.9, 95% CI 4.4-7.4). Significant differences in POP-SS score were detected after surgery and PFMT. The improvement due to surgery was significantly greater than that associated with PFMT (z = -3.006, P = 0.003). ConclusionThe POP-SS has good internal consistency and construct validity and is sensitive to change.

Forty-seven women participated in a pilot study for a multi-centre randomized controlled trial of the effectiveness of pelvic floor muscle training (PFMT) for women with prolapse. Women with symptomatic stage I or II prolapse [measured by Pelvic Organ Prolapse Quantification (POP-Q)] were randomized to a 16-week physiotherapy intervention (PFMT and lifestyle advice; n = 23) or a control group receiving a lifestyle advice sheet (n = 24). Symptom severity and quality of life were measured via postal questionnaires. Blinded POP-Q was performed at baseline and follow-up. Intervention women had significantly greater improvement than controls in prolapse symptoms (mean score decrease 3.5 versus 0.1, p = 0.021), were significantly more likely to have an improved prolapse stage (45% versus 0%, p = 0.038) and were significantly more likely to say their prolapse was better (63% versus 24%, p = 0.012). The data support the feasibility of a substantive trial of PFMT for prolapse. A multi-centre trial is underway.