PROSPECT: 4- and 6-year follow-up of a randomised trial of surgery for vaginal prolapse

Fiona M. Reid; Lorna Aucott; Cathryn M.A. Glazener; Andrew Elders; Christine Hemming; Kevin G. Cooper; Robert M. Freeman; Anthony R.B. Smith; Suzanne Hagen; Mary Kilonzo; Dwayne Boyers; Graeme MacLennan; John Norrie; Suzanne Breeman; PROSPECT study group

doi:10.1007/s00192-022-05308-0

PROSPECT: 4- and 6-year follow-up of a randomised trial of surgery for vaginal prolapse

Fiona M. Reid^* (Corresponding Author)
, Lorna Aucott
, Cathryn M.A. Glazener
, Andrew Elders
, Christine Hemming
, Kevin G. Cooper
, Robert M. Freeman
, Anthony R.B. Smith
, Suzanne Hagen
, Mary Kilonzo
, Dwayne Boyers
, Graeme MacLennan
, John Norrie
, Suzanne Breeman
, PROSPECT study group

^*Corresponding author for this work

Manchester University NHS Foundation Trust
Glasgow Caledonian University
Aberdeen Royal Infirmary
University Hospitals Plymouth NHS Trust
University of Edinburgh

Research output: Contribution to journal › Article › peer-review

14 Citations (Scopus)

12 Downloads (Pure)

Abstract

Introduction and hypothesis: Our aim was to compare the mid-term results of native tissue, biological xenograft and polypropylene mesh surgery for women with vaginal wall prolapse. Methods: A total of 1348 women undergoing primary transvaginal repair of an anterior and/or posterior prolapse were recruited between January 2010 and August 2013 from 35 UK centres. They were randomised by remote allocation to native tissue surgery, biological xenograft or polypropylene mesh. We performed both 4- and 6-year follow-up using validated patient-reported outcome measures. Results: At 4 and 6 years post-operation, there was no clinically important difference in Pelvic Organ Prolapse Symptom Score for any of the treatments. Using a strict composite outcome to assess functional cure at 6 years, we found no difference in cure among the three types of surgery. Half the women were cured at 6 years but only 10.3 to 12% of women had undergone further surgery for prolapse. However, 8.4% of women in the mesh group had undergone further surgery for mesh complications. There was no difference in the incidence of chronic pain or dyspareunia between groups. Conclusions: At the mid-term outcome of 6 years, there is no benefit from augmenting primary prolapse repairs with polypropylene mesh inlays or biological xenografts. There was no evidence that polypropylene mesh inlays caused greater pain or dyspareunia than native tissue repairs.

Original language	English
Pages (from-to)	67-78
Number of pages	12
Journal	International Urogynecology Journal
Volume	34
Early online date	26 Aug 2022
DOIs	https://doi.org/10.1007/s00192-022-05308-0
Publication status	Published - 1 Apr 2023

Bibliographical note

Funding: The project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (Project Number 07/60/18). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The Health Services Research Unit and the Health Economics Research Unit are funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates.
Trial registration: ISRCTN60695184

Data Availability Statement

Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s00192-022-05308-0.

Funding

The project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (Project Number 07/60/18). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The Health Services Research Unit and the Health Economics Research Unit are funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The strength of PROSPECT remains its size, generalisability and robust methodology. Unlike other studies criticised in the Cumberlege report [] for being sponsored by industry, PROSPECT was independent, funded by the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme.

Keywords

Polypropylene mesh
Prolapse
Randomised trial
Xenograft

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Cite this

Reid, F. M., Aucott, L., Glazener, C. M. A., Elders, A., Hemming, C., Cooper, K. G., Freeman, R. M., Smith, A. R. B., Hagen, S., Kilonzo, M., Boyers, D., MacLennan, G., Norrie, J., Breeman, S., & PROSPECT study group (2023). PROSPECT: 4- and 6-year follow-up of a randomised trial of surgery for vaginal prolapse. International Urogynecology Journal, 34, 67-78. https://doi.org/10.1007/s00192-022-05308-0

Reid, FM, Aucott, L, Glazener, CMA, Elders, A, Hemming, C, Cooper, KG, Freeman, RM, Smith, ARB, Hagen, S, Kilonzo, M , Boyers, D , MacLennan, G, Norrie, J, Breeman, S & PROSPECT study group 2023, 'PROSPECT: 4- and 6-year follow-up of a randomised trial of surgery for vaginal prolapse', International Urogynecology Journal, vol. 34, pp. 67-78. https://doi.org/10.1007/s00192-022-05308-0

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title = "PROSPECT: 4- and 6-year follow-up of a randomised trial of surgery for vaginal prolapse",

abstract = "Introduction and hypothesis: Our aim was to compare the mid-term results of native tissue, biological xenograft and polypropylene mesh surgery for women with vaginal wall prolapse. Methods: A total of 1348 women undergoing primary transvaginal repair of an anterior and/or posterior prolapse were recruited between January 2010 and August 2013 from 35 UK centres. They were randomised by remote allocation to native tissue surgery, biological xenograft or polypropylene mesh. We performed both 4- and 6-year follow-up using validated patient-reported outcome measures. Results: At 4 and 6 years post-operation, there was no clinically important difference in Pelvic Organ Prolapse Symptom Score for any of the treatments. Using a strict composite outcome to assess functional cure at 6 years, we found no difference in cure among the three types of surgery. Half the women were cured at 6 years but only 10.3 to 12\% of women had undergone further surgery for prolapse. However, 8.4\% of women in the mesh group had undergone further surgery for mesh complications. There was no difference in the incidence of chronic pain or dyspareunia between groups. Conclusions: At the mid-term outcome of 6 years, there is no benefit from augmenting primary prolapse repairs with polypropylene mesh inlays or biological xenografts. There was no evidence that polypropylene mesh inlays caused greater pain or dyspareunia than native tissue repairs.",

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author = "Reid, \{Fiona M.\} and Lorna Aucott and Glazener, \{Cathryn M.A.\} and Andrew Elders and Christine Hemming and Cooper, \{Kevin G.\} and Freeman, \{Robert M.\} and Smith, \{Anthony R.B.\} and Suzanne Hagen and Mary Kilonzo and Dwayne Boyers and Graeme MacLennan and John Norrie and Suzanne Breeman and \{PROSPECT study group\}",

note = "Funding: The project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (Project Number 07/60/18). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The Health Services Research Unit and the Health Economics Research Unit are funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. Trial registration: ISRCTN60695184 ",

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AU - Reid, Fiona M.

AU - Aucott, Lorna

AU - Glazener, Cathryn M.A.

AU - Elders, Andrew

AU - Hemming, Christine

AU - Cooper, Kevin G.

AU - Freeman, Robert M.

AU - Smith, Anthony R.B.

AU - Hagen, Suzanne

AU - Kilonzo, Mary

AU - Boyers, Dwayne

AU - MacLennan, Graeme

AU - Norrie, John

AU - Breeman, Suzanne

AU - PROSPECT study group

N1 - Funding: The project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (Project Number 07/60/18). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. The Health Services Research Unit and the Health Economics Research Unit are funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. Trial registration: ISRCTN60695184

PY - 2023/4/1

Y1 - 2023/4/1

N2 - Introduction and hypothesis: Our aim was to compare the mid-term results of native tissue, biological xenograft and polypropylene mesh surgery for women with vaginal wall prolapse. Methods: A total of 1348 women undergoing primary transvaginal repair of an anterior and/or posterior prolapse were recruited between January 2010 and August 2013 from 35 UK centres. They were randomised by remote allocation to native tissue surgery, biological xenograft or polypropylene mesh. We performed both 4- and 6-year follow-up using validated patient-reported outcome measures. Results: At 4 and 6 years post-operation, there was no clinically important difference in Pelvic Organ Prolapse Symptom Score for any of the treatments. Using a strict composite outcome to assess functional cure at 6 years, we found no difference in cure among the three types of surgery. Half the women were cured at 6 years but only 10.3 to 12% of women had undergone further surgery for prolapse. However, 8.4% of women in the mesh group had undergone further surgery for mesh complications. There was no difference in the incidence of chronic pain or dyspareunia between groups. Conclusions: At the mid-term outcome of 6 years, there is no benefit from augmenting primary prolapse repairs with polypropylene mesh inlays or biological xenografts. There was no evidence that polypropylene mesh inlays caused greater pain or dyspareunia than native tissue repairs.

AB - Introduction and hypothesis: Our aim was to compare the mid-term results of native tissue, biological xenograft and polypropylene mesh surgery for women with vaginal wall prolapse. Methods: A total of 1348 women undergoing primary transvaginal repair of an anterior and/or posterior prolapse were recruited between January 2010 and August 2013 from 35 UK centres. They were randomised by remote allocation to native tissue surgery, biological xenograft or polypropylene mesh. We performed both 4- and 6-year follow-up using validated patient-reported outcome measures. Results: At 4 and 6 years post-operation, there was no clinically important difference in Pelvic Organ Prolapse Symptom Score for any of the treatments. Using a strict composite outcome to assess functional cure at 6 years, we found no difference in cure among the three types of surgery. Half the women were cured at 6 years but only 10.3 to 12% of women had undergone further surgery for prolapse. However, 8.4% of women in the mesh group had undergone further surgery for mesh complications. There was no difference in the incidence of chronic pain or dyspareunia between groups. Conclusions: At the mid-term outcome of 6 years, there is no benefit from augmenting primary prolapse repairs with polypropylene mesh inlays or biological xenografts. There was no evidence that polypropylene mesh inlays caused greater pain or dyspareunia than native tissue repairs.

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KW - Randomised trial

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AN - SCOPUS:85137038233

SN - 0937-3462

VL - 34

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JO - International Urogynecology Journal

JF - International Urogynecology Journal

ER -

PROSPECT: 4- and 6-year follow-up of a randomised trial of surgery for vaginal prolapse

Abstract

Bibliographical note

Data Availability Statement

Funding

Keywords

Access to Document

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