Pelvic floor muscle training for secondary prevention of pelvic organ prolapse (PREVPROL)

a multicentre randomised controlled trial

Suzanne Hagen*, Cathryn Glazener, Doreen McClurg, Christine Macarthur, Andrew Elders, Peter Herbison, Don Wilson, Philip Toozs-Hobson, Christine Hemming, Jean Hay-Smith, Marissa Collins, Sylvia Dickson, Janet Logan

*Corresponding author for this work

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

Background Pelvic floor muscle training can reduce prolapse severity and symptoms in women seeking treatment. We aimed to assess whether this intervention could also be effective in secondary prevention of prolapse and the need for future treatment. Methods We did this multicentre, parallel-group, randomised controlled trial at three centres in New Zealand and the UK. Women from a longitudinal study of pelvic floor function after childbirth were potentially eligible for inclusion. Women of any age who had stage 1–3 prolapse, but had not sought treatment, were randomly assigned (1:1), via remote computer allocation, to receive either one-to-one pelvic floor muscle training (five physiotherapy appointments over 16 weeks, and annual review) plus Pilates-based pelvic floor muscle training classes and a DVD for home use (intervention group), or a prolapse lifestyle advice leaflet (control group). Randomisation was minimised by centre, parity (three or less vs more than three deliveries), prolapse stage (above the hymen vs at or beyond the hymen), and delivery method (any vaginal vs all caesarean sections). Women and intervention physiotherapists could not be masked to group allocation, but allocation was masked from data entry researchers and from the trial statistician until after database lock. The primary outcome was self-reported prolapse symptoms (Pelvic Organ Prolapse Symptom Score [POP-SS]) at 2 years. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01171846. Findings Between Dec 21, 2008, and Feb 24, 2010, in New Zealand, and Oct 27, 2010, and Sept 5, 2011, in the UK, we randomly assigned 414 women to the intervention group (n=207) or the control group (n=207). One participant in each group was excluded after randomisation, leaving 412 women for analysis. At baseline, 399 (97%) women had prolapse above or at the level of the hymen. The mean POP-SS score at 2 years was 3·2 (SD 3·4) in the intervention group versus 4·2 (SD 4·4) in the control group (adjusted mean difference −1·01, 95% CI −1·70 to −0·33; p=0·004). The mean symptom score stayed similar across time points in the control group, but decreased in the intervention group. Three adverse events were reported, all of which were in the intervention group (one women had a fall, one woman had a pain in her tail bone, and one woman had chest pain and shortness of breath). Interpretation Our study shows that pelvic floor muscle training leads to a small, but probably important, reduction in prolapse symptoms. This finding will be important for women and caregivers considering preventive strategies. Funding Wellbeing of Women charity, the New Zealand Continence Association, and the Dean's Bequest Fund of Dunedin School of Medicine.

Original languageEnglish
Pages (from-to)393-402
Number of pages10
JournalThe Lancet
Volume389
Issue number10067
Early online date21 Dec 2016
DOIs
Publication statusPublished - 28 Jan 2017

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Pelvic Organ Prolapse
Pelvic Floor
Secondary Prevention
Randomized Controlled Trials
Prolapse
Muscles
Hymen
New Zealand
Control Groups
Random Allocation
Charities
Intention to Treat Analysis
Physical Therapists
Parity
Chest Pain
Cesarean Section
Dyspnea
Caregivers
Longitudinal Studies
Life Style

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Pelvic floor muscle training for secondary prevention of pelvic organ prolapse (PREVPROL) : a multicentre randomised controlled trial. / Hagen, Suzanne; Glazener, Cathryn; McClurg, Doreen; Macarthur, Christine; Elders, Andrew; Herbison, Peter; Wilson, Don; Toozs-Hobson, Philip; Hemming, Christine; Hay-Smith, Jean; Collins, Marissa; Dickson, Sylvia; Logan, Janet.

In: The Lancet, Vol. 389, No. 10067, 28.01.2017, p. 393-402.

Research output: Contribution to journalArticle

Hagen, S, Glazener, C, McClurg, D, Macarthur, C, Elders, A, Herbison, P, Wilson, D, Toozs-Hobson, P, Hemming, C, Hay-Smith, J, Collins, M, Dickson, S & Logan, J 2017, 'Pelvic floor muscle training for secondary prevention of pelvic organ prolapse (PREVPROL): a multicentre randomised controlled trial', The Lancet, vol. 389, no. 10067, pp. 393-402. https://doi.org/10.1016/S0140-6736(16)32109-2
Hagen, Suzanne ; Glazener, Cathryn ; McClurg, Doreen ; Macarthur, Christine ; Elders, Andrew ; Herbison, Peter ; Wilson, Don ; Toozs-Hobson, Philip ; Hemming, Christine ; Hay-Smith, Jean ; Collins, Marissa ; Dickson, Sylvia ; Logan, Janet. / Pelvic floor muscle training for secondary prevention of pelvic organ prolapse (PREVPROL) : a multicentre randomised controlled trial. In: The Lancet. 2017 ; Vol. 389, No. 10067. pp. 393-402.
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abstract = "Background Pelvic floor muscle training can reduce prolapse severity and symptoms in women seeking treatment. We aimed to assess whether this intervention could also be effective in secondary prevention of prolapse and the need for future treatment. Methods We did this multicentre, parallel-group, randomised controlled trial at three centres in New Zealand and the UK. Women from a longitudinal study of pelvic floor function after childbirth were potentially eligible for inclusion. Women of any age who had stage 1–3 prolapse, but had not sought treatment, were randomly assigned (1:1), via remote computer allocation, to receive either one-to-one pelvic floor muscle training (five physiotherapy appointments over 16 weeks, and annual review) plus Pilates-based pelvic floor muscle training classes and a DVD for home use (intervention group), or a prolapse lifestyle advice leaflet (control group). Randomisation was minimised by centre, parity (three or less vs more than three deliveries), prolapse stage (above the hymen vs at or beyond the hymen), and delivery method (any vaginal vs all caesarean sections). Women and intervention physiotherapists could not be masked to group allocation, but allocation was masked from data entry researchers and from the trial statistician until after database lock. The primary outcome was self-reported prolapse symptoms (Pelvic Organ Prolapse Symptom Score [POP-SS]) at 2 years. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01171846. Findings Between Dec 21, 2008, and Feb 24, 2010, in New Zealand, and Oct 27, 2010, and Sept 5, 2011, in the UK, we randomly assigned 414 women to the intervention group (n=207) or the control group (n=207). One participant in each group was excluded after randomisation, leaving 412 women for analysis. At baseline, 399 (97{\%}) women had prolapse above or at the level of the hymen. The mean POP-SS score at 2 years was 3·2 (SD 3·4) in the intervention group versus 4·2 (SD 4·4) in the control group (adjusted mean difference −1·01, 95{\%} CI −1·70 to −0·33; p=0·004). The mean symptom score stayed similar across time points in the control group, but decreased in the intervention group. Three adverse events were reported, all of which were in the intervention group (one women had a fall, one woman had a pain in her tail bone, and one woman had chest pain and shortness of breath). Interpretation Our study shows that pelvic floor muscle training leads to a small, but probably important, reduction in prolapse symptoms. This finding will be important for women and caregivers considering preventive strategies. Funding Wellbeing of Women charity, the New Zealand Continence Association, and the Dean's Bequest Fund of Dunedin School of Medicine.",
author = "Suzanne Hagen and Cathryn Glazener and Doreen McClurg and Christine Macarthur and Andrew Elders and Peter Herbison and Don Wilson and Philip Toozs-Hobson and Christine Hemming and Jean Hay-Smith and Marissa Collins and Sylvia Dickson and Janet Logan",
note = "This study was funded by the Wellbeing of Women charity, the New Zealand Continence Association, and the Dean's Bequest Fund of Dunedin School of Medicine. CM was part-funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West Midlands. We thank all the women who willingly participated in the trial and completed their questionnaires and attended physiotherapy and classes; the staff at each of our centres for recruiting, motivating and treating our participants (Diane Stark, Nina Bridges, Emma James, Helene Simmons, Kumbi Gwatidzo, Jenny Corbett, Sandra Whyte, Elizabeth Crothers, Gail Hyland, Leslie Inglis, and Evelyn Tulloch); staff who did POP-Q assessments (Nicola Dean, Helen Paterson, Matthew Parsons, Karen Richardson, Elizabeth Crothers); staff who assisted the trial office in the UK (Gladys McPherson, Nicole Sergenson, Anne Taylor); staff who administered the trial in Dunedin (Gaye Ellis), and members of the trial steering committee for giving their time in advising the trial team throughout the work.",
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TY - JOUR

T1 - Pelvic floor muscle training for secondary prevention of pelvic organ prolapse (PREVPROL)

T2 - a multicentre randomised controlled trial

AU - Hagen, Suzanne

AU - Glazener, Cathryn

AU - McClurg, Doreen

AU - Macarthur, Christine

AU - Elders, Andrew

AU - Herbison, Peter

AU - Wilson, Don

AU - Toozs-Hobson, Philip

AU - Hemming, Christine

AU - Hay-Smith, Jean

AU - Collins, Marissa

AU - Dickson, Sylvia

AU - Logan, Janet

N1 - This study was funded by the Wellbeing of Women charity, the New Zealand Continence Association, and the Dean's Bequest Fund of Dunedin School of Medicine. CM was part-funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West Midlands. We thank all the women who willingly participated in the trial and completed their questionnaires and attended physiotherapy and classes; the staff at each of our centres for recruiting, motivating and treating our participants (Diane Stark, Nina Bridges, Emma James, Helene Simmons, Kumbi Gwatidzo, Jenny Corbett, Sandra Whyte, Elizabeth Crothers, Gail Hyland, Leslie Inglis, and Evelyn Tulloch); staff who did POP-Q assessments (Nicola Dean, Helen Paterson, Matthew Parsons, Karen Richardson, Elizabeth Crothers); staff who assisted the trial office in the UK (Gladys McPherson, Nicole Sergenson, Anne Taylor); staff who administered the trial in Dunedin (Gaye Ellis), and members of the trial steering committee for giving their time in advising the trial team throughout the work.

PY - 2017/1/28

Y1 - 2017/1/28

N2 - Background Pelvic floor muscle training can reduce prolapse severity and symptoms in women seeking treatment. We aimed to assess whether this intervention could also be effective in secondary prevention of prolapse and the need for future treatment. Methods We did this multicentre, parallel-group, randomised controlled trial at three centres in New Zealand and the UK. Women from a longitudinal study of pelvic floor function after childbirth were potentially eligible for inclusion. Women of any age who had stage 1–3 prolapse, but had not sought treatment, were randomly assigned (1:1), via remote computer allocation, to receive either one-to-one pelvic floor muscle training (five physiotherapy appointments over 16 weeks, and annual review) plus Pilates-based pelvic floor muscle training classes and a DVD for home use (intervention group), or a prolapse lifestyle advice leaflet (control group). Randomisation was minimised by centre, parity (three or less vs more than three deliveries), prolapse stage (above the hymen vs at or beyond the hymen), and delivery method (any vaginal vs all caesarean sections). Women and intervention physiotherapists could not be masked to group allocation, but allocation was masked from data entry researchers and from the trial statistician until after database lock. The primary outcome was self-reported prolapse symptoms (Pelvic Organ Prolapse Symptom Score [POP-SS]) at 2 years. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01171846. Findings Between Dec 21, 2008, and Feb 24, 2010, in New Zealand, and Oct 27, 2010, and Sept 5, 2011, in the UK, we randomly assigned 414 women to the intervention group (n=207) or the control group (n=207). One participant in each group was excluded after randomisation, leaving 412 women for analysis. At baseline, 399 (97%) women had prolapse above or at the level of the hymen. The mean POP-SS score at 2 years was 3·2 (SD 3·4) in the intervention group versus 4·2 (SD 4·4) in the control group (adjusted mean difference −1·01, 95% CI −1·70 to −0·33; p=0·004). The mean symptom score stayed similar across time points in the control group, but decreased in the intervention group. Three adverse events were reported, all of which were in the intervention group (one women had a fall, one woman had a pain in her tail bone, and one woman had chest pain and shortness of breath). Interpretation Our study shows that pelvic floor muscle training leads to a small, but probably important, reduction in prolapse symptoms. This finding will be important for women and caregivers considering preventive strategies. Funding Wellbeing of Women charity, the New Zealand Continence Association, and the Dean's Bequest Fund of Dunedin School of Medicine.

AB - Background Pelvic floor muscle training can reduce prolapse severity and symptoms in women seeking treatment. We aimed to assess whether this intervention could also be effective in secondary prevention of prolapse and the need for future treatment. Methods We did this multicentre, parallel-group, randomised controlled trial at three centres in New Zealand and the UK. Women from a longitudinal study of pelvic floor function after childbirth were potentially eligible for inclusion. Women of any age who had stage 1–3 prolapse, but had not sought treatment, were randomly assigned (1:1), via remote computer allocation, to receive either one-to-one pelvic floor muscle training (five physiotherapy appointments over 16 weeks, and annual review) plus Pilates-based pelvic floor muscle training classes and a DVD for home use (intervention group), or a prolapse lifestyle advice leaflet (control group). Randomisation was minimised by centre, parity (three or less vs more than three deliveries), prolapse stage (above the hymen vs at or beyond the hymen), and delivery method (any vaginal vs all caesarean sections). Women and intervention physiotherapists could not be masked to group allocation, but allocation was masked from data entry researchers and from the trial statistician until after database lock. The primary outcome was self-reported prolapse symptoms (Pelvic Organ Prolapse Symptom Score [POP-SS]) at 2 years. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01171846. Findings Between Dec 21, 2008, and Feb 24, 2010, in New Zealand, and Oct 27, 2010, and Sept 5, 2011, in the UK, we randomly assigned 414 women to the intervention group (n=207) or the control group (n=207). One participant in each group was excluded after randomisation, leaving 412 women for analysis. At baseline, 399 (97%) women had prolapse above or at the level of the hymen. The mean POP-SS score at 2 years was 3·2 (SD 3·4) in the intervention group versus 4·2 (SD 4·4) in the control group (adjusted mean difference −1·01, 95% CI −1·70 to −0·33; p=0·004). The mean symptom score stayed similar across time points in the control group, but decreased in the intervention group. Three adverse events were reported, all of which were in the intervention group (one women had a fall, one woman had a pain in her tail bone, and one woman had chest pain and shortness of breath). Interpretation Our study shows that pelvic floor muscle training leads to a small, but probably important, reduction in prolapse symptoms. This finding will be important for women and caregivers considering preventive strategies. Funding Wellbeing of Women charity, the New Zealand Continence Association, and the Dean's Bequest Fund of Dunedin School of Medicine.

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