Individualised pelvic floor muscle training in women with pelvic organ prolapse (POPPY)

a multicentre randomised controlled trial

Suzanne Hagen, Diane Stark, Cathryn Glazener, Sylvia Dickson, Sarah Barry, Andrew Elders, Helena Frawley, Mary P Galea, Janet Logan, Alison McDonald, Gladys McPherson, Kate H Moore, John Norrie, Andrew Walker, Don Wilson, POPPY Trial Collaborators

Research output: Contribution to journalArticle

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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.

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.

FUNDING: Chief Scientist Office of the Scottish Government Health and Social Care Directorates, New Zealand Lottery Board, and National Health and Medical Research Council (Australia).

Original languageEnglish
Pages (from-to)796-806
Number of pages11
JournalThe Lancet
Volume383
Issue number9919
Early online date28 Nov 2013
DOIs
Publication statusPublished - 1 Mar 2014

Fingerprint

Pelvic Organ Prolapse
Pelvic Floor
Prolapse
Randomized Controlled Trials
Muscles
New Zealand
Control Groups
Exercise
Intention to Treat Analysis
Back Pain
Self Report
Abdominal Pain
Biomedical Research
Life Style
Outpatients
Research Personnel
Parturition
Delivery of Health Care
Health

Keywords

  • ambulatory care
  • exercise therapy
  • female
  • humans
  • individualized medicine
  • middle aged
  • pelvic floor
  • pelvic organ prolapse
  • treatment outcome

Cite this

Individualised pelvic floor muscle training in women with pelvic organ prolapse (POPPY) : a multicentre randomised controlled trial. / Hagen, Suzanne; Stark, Diane; Glazener, Cathryn; Dickson, Sylvia; Barry, Sarah; Elders, Andrew; Frawley, Helena; Galea, Mary P; Logan, Janet; McDonald, Alison; McPherson, Gladys; Moore, Kate H; Norrie, John; Walker, Andrew; Wilson, Don; POPPY Trial Collaborators.

In: The Lancet, Vol. 383, No. 9919, 01.03.2014, p. 796-806.

Research output: Contribution to journalArticle

Hagen, S, Stark, D, Glazener, C, Dickson, S, Barry, S, Elders, A, Frawley, H, Galea, MP, Logan, J, McDonald, A, McPherson, G, Moore, KH, Norrie, J, Walker, A, Wilson, D & POPPY Trial Collaborators 2014, 'Individualised pelvic floor muscle training in women with pelvic organ prolapse (POPPY): a multicentre randomised controlled trial', The Lancet, vol. 383, no. 9919, pp. 796-806. https://doi.org/10.1016/S0140-6736(13)61977-7
Hagen, Suzanne ; Stark, Diane ; Glazener, Cathryn ; Dickson, Sylvia ; Barry, Sarah ; Elders, Andrew ; Frawley, Helena ; Galea, Mary P ; Logan, Janet ; McDonald, Alison ; McPherson, Gladys ; Moore, Kate H ; Norrie, John ; Walker, Andrew ; Wilson, Don ; POPPY Trial Collaborators. / Individualised pelvic floor muscle training in women with pelvic organ prolapse (POPPY) : a multicentre randomised controlled trial. In: The Lancet. 2014 ; Vol. 383, No. 9919. pp. 796-806.
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T1 - Individualised pelvic floor muscle training in women with pelvic organ prolapse (POPPY)

T2 - a multicentre randomised controlled trial

AU - Hagen, Suzanne

AU - Stark, Diane

AU - Glazener, Cathryn

AU - Dickson, Sylvia

AU - Barry, Sarah

AU - Elders, Andrew

AU - Frawley, Helena

AU - Galea, Mary P

AU - Logan, Janet

AU - McDonald, Alison

AU - McPherson, Gladys

AU - Moore, Kate H

AU - Norrie, John

AU - Walker, Andrew

AU - Wilson, Don

AU - POPPY Trial Collaborators

N1 - Copyright © 2014 Elsevier Ltd. All rights reserved.

PY - 2014/3/1

Y1 - 2014/3/1

N2 - 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.FUNDING: Chief Scientist Office of the Scottish Government Health and Social Care Directorates, New Zealand Lottery Board, and National Health and Medical Research Council (Australia).

AB - 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.FUNDING: Chief Scientist Office of the Scottish Government Health and Social Care Directorates, New Zealand Lottery Board, and National Health and Medical Research Council (Australia).

KW - ambulatory care

KW - exercise therapy

KW - female

KW - humans

KW - individualized medicine

KW - middle aged

KW - pelvic floor

KW - pelvic organ prolapse

KW - treatment outcome

U2 - 10.1016/S0140-6736(13)61977-7

DO - 10.1016/S0140-6736(13)61977-7

M3 - Article

VL - 383

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EP - 806

JO - The Lancet

JF - The Lancet

SN - 0140-6736

IS - 9919

ER -