title: Individualised pelvic floor muscle training in women with pelvic organ prolapse (POPPY): a multicentre randomised controlled trial.
abstract: 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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Chief Scientist Office of the Scottish Government Health and Social Care Directorates, New Zealand Lottery Board, and National Health and Medical Research Council (Australia).
authors.affiliation: Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK. Electronic address: s.hagen@gcu.ac.uk.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Hagen
authors.affiliation: Clinic 2, Balmoral Building, Leicester Royal Infirmary, Leicester, UK.
authors.forename: Diane
authors.initials: D
authors.lastname: Stark
authors.affiliation: Health Services Research Unit, Third Floor Health Sciences Building, University of Aberdeen, Aberdeen, UK.
authors.forename: Cathryn
authors.initials: C
authors.lastname: Glazener
authors.affiliation: Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.
authors.forename: Sylvia
authors.initials: S
authors.lastname: Dickson
authors.affiliation: Robertson Centre for Biostatistics, University of Glasgow, Boyd Orr Building, Glasgow, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Barry
authors.affiliation: Health Services Research Unit, Third Floor Health Sciences Building, University of Aberdeen, Aberdeen, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Elders
authors.affiliation: Department of Physiotherapy, Melbourne School of Health Sciences, University of Melbourne, VIC, Australia.
authors.forename: Helena
authors.initials: H
authors.lastname: Frawley
authors.affiliation: Department of Medicine-Royal Melbourne Hospital, University of Melbourne, VIC, Australia.
authors.forename: Mary P
authors.initials: MP
authors.lastname: Galea
authors.affiliation: Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.
authors.forename: Janet
authors.initials: J
authors.lastname: Logan
authors.affiliation: Centre for Healthcare Randomised Trials, Health Services Research Unit, Third Floor Health Sciences Building, University of Aberdeen, Aberdeen, UK.
authors.forename: Alison
authors.initials: A
authors.lastname: McDonald
authors.affiliation: Centre for Healthcare Randomised Trials, Health Services Research Unit, Third Floor Health Sciences Building, University of Aberdeen, Aberdeen, UK.
authors.forename: Gladys
authors.initials: G
authors.lastname: McPherson
authors.affiliation: Pelvic Floor and Bladder Unit, Department of Urogynaecology, St George Hospital, NSW, Australia.
authors.forename: Kate H
authors.initials: KH
authors.lastname: Moore
authors.affiliation: Centre for Healthcare Randomised Trials, Health Services Research Unit, Third Floor Health Sciences Building, University of Aberdeen, Aberdeen, UK.
authors.forename: John
authors.initials: J
authors.lastname: Norrie
authors.affiliation: Robertson Centre for Biostatistics, University of Glasgow, Boyd Orr Building, Glasgow, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Walker
authors.affiliation: Department of Obstetrics and Gynaecology, Dunedin School of Medicine, Dunedin, New Zealand.
authors.forename: Don
authors.initials: D
authors.lastname: Wilson
mesh_terms: D000553:Ambulatory Care; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D017773:Pelvic Floor; D056887:Pelvic Organ Prolapse / Q000628:therapy*; D057285:Precision Medicine / Q000379:methods; D016896:Treatment Outcome