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

被引：172

作者：

Hagen, Suzanne ^{[1
]}

Stark, Diane ^{[2
]}

Glazener, Cathryn ^{[3
]}

Dickson, Sylvia ^{[1
]}

Barry, Sarah ^{[5
]}

Elders, Andrew ^{[3
]}

Frawley, Helena ^{[6
]}

Galea, Mary P. ^{[7
]}

Logan, Janet ^{[1
]}

McDonald, Alison ^{[4
]}

McPherson, Gladys ^{[4
]}

Moore, Kate H. ^{[8
]}

Norrie, John ^{[4
]}

Walker, Andrew ^{[5
]}

Wilson, Don ^{[9
]}

机构：

[1] Glasgow Caledonian Univ, Nursing Midwifery & Allied Hlth Profess Res Unit, Glasgow G4 0BA, Lanark, Scotland

[2] Leicester Royal Infirm, Clin 2, Leicester, Leics, England

[3] Univ Aberdeen, Hlth Serv Res Unit, Aberdeen, Scotland

[4] Univ Aberdeen, Hlth Serv Res Unit, Ctr Healthcare Randomised Trials, Aberdeen, Scotland

[5] Univ Glasgow, Robertson Ctr Biostat, Glasgow, Lanark, Scotland

[6] Univ Melbourne, Melbourne Sch Hlth Sci, Dept Physiotherapy, Melbourne, Vic 3010, Australia

[7] Univ Melbourne, Royal Melbourne Hosp, Dept Med, Melbourne, Vic 3010, Australia

[8] St George Hosp, Dept Urogynaecol, Pelv Floor & Bladder Unit, Kogarah, NSW, Australia

[9] Dunedin Sch Med, Dept Obstet & Gynaecol, Dunedin, New Zealand

来源：

LANCET | 2014年 / 383卷 / 9919期

基金：

英国医学研究理事会;

关键词：

SHORT-FORM; SYMPTOMS;

D O I：

10.1016/S0140-6736(13)61977-7

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background Pelvic organ prolapse is common and is strongly associated with childbirth and increasing age. Women with prolapse are often advised to do pelvic floor muscle exercises, but evidence supporting the benefits of such exercises is scarce. We aimed to establish the effectiveness of one-to-one individualised pelvic floor muscle training for reducing prolapse symptoms. Methods We did a parallel-group, multicentre, randomised controlled trial at 23 centres in the UK, one in New Zealand, and one in Australia, between June 22, 2007, and April 9, 2010. Female outpatients with newly-diagnosed, symptomatic stage I, II, or III prolapse were randomly assigned (1:1), by remote computer allocation with minimsation, to receive an individualised programme of pelvic floor muscle training or a prolapse lifestyle advice leaflet and no muscle training (control group). Outcome assessors, and investigators who were gynaecologists at trial sites, were masked to group allocation; the statistician was masked until after data analysis. Our primary endpoint was participants' self-report of prolapse symptoms at 12 months. Analysis was by intention-to-treat analysis. This trial is registered, number ISRCTN35911035. Findings 447 eligible patients were randomised to the intervention group (n=225) or the control group (n=222). 377 (84%) participants completed follow-up for questionnaires at 6 months and 295 (66%) for questionnaires at 12 months. Women in the intervention group reported fewer prolapse symptoms (ie, a significantly greater reduction in the pelvic organ prolapse symptom score [POP-SS]) at 12 months than those in the control group (mean reduction in POP-SS from baseline 3.77 [SD 5.62] vs 2.09 [5.39]; adjusted difference 1.52, 95% CI 0.46-2.59; p=0.0053). Findings were robust to missing data. Eight adverse events (six vaginal symptoms, one case of back pain, and one case of abdominal pain) and one unexpected serious adverse event, all in women from the intervention group, were regarded as unrelated to the intervention or to participation in the study. Interpretation One-to-one pelvic floor muscle training for prolapse is effective for improvement of prolapse symptoms. Long-term benefits should be investigated, as should the effects in specific subgroups.

引用

页码：796 / 806

页数：11

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