Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial

Cathryn Glazener; Lynda Constable; Christine Hemming; Suzanne Breeman; Andrew Elders; Kevin Cooper; Robert Freeman; Anthony R.B. Smith; Suzanne Hagen; Alison McDonald; Gladys McPherson; Isobel Montgomery; Mary Kilonzo; Dwayne Boyers; Beatriz Goulao; John Norrie

doi:10.1186/s13063-016-1576-x

Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial

Cathryn Glazener, Lynda Constable, Christine Hemming, Suzanne Breeman, Andrew Elders, Kevin Cooper, Robert Freeman, Anthony R.B. Smith, Suzanne Hagen, Alison McDonald, Gladys McPherson, Isobel Montgomery, Mary Kilonzo, Dwayne Boyers, Beatriz Goulao, John Norrie

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Abstract

Background: One in three women who have a prolapse operation will go on to have another operation, though not necessarily in the same compartment. Surgery can result in greater impairment of quality of life than the original prolapse itself (such as the development of new-onset urinary incontinence, or prolapse at a different site). Anterior and posterior prolapse surgery is most common (90 % of operations), but around 43 % of women also have a uterine (34 %) or vault (9 %) procedure at the same time. There is not enough evidence from randomised controlled trials (RCTs) to guide management of vault or uterine prolapse. The Vault or Uterine prolapse surgery Evaluation (VUE) study aims to assess the surgical management of upper compartment pelvic organ prolapse (POP) in terms of clinical effectiveness, cost-effectiveness and adverse events.

Original language	English
Pages (from-to)	441
Number of pages	18
Journal	Trials
Volume	17
Early online date	8 Sep 2016
DOIs	https://doi.org/10.1186/s13063-016-1576-x
Publication status	Published - Sep 2016

Keywords

pelvic organ prolapse
randomised controlled trials
study protocol

Documents and Links

10.1186/s13063-016-1576-x

Glazener, C (2016) Trials journal article
© 2016 The Author(s). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Final published version, 1.06 MBLicence: CC BY

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Glazener, C., Constable, L., Hemming, C., Breeman, S., Elders, A., Cooper, K., Freeman, R., Smith, A. R. B., Hagen, S., McDonald, A., McPherson, G., Montgomery, I., Kilonzo, M., Boyers, D., Goulao, B., & Norrie, J. (2016). Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial. Trials, 17, 441. https://doi.org/10.1186/s13063-016-1576-x

Glazener, Cathryn ; Constable, Lynda ; Hemming, Christine ; Breeman, Suzanne ; Elders, Andrew ; Cooper, Kevin ; Freeman, Robert ; Smith, Anthony R.B. ; Hagen, Suzanne ; McDonald, Alison ; McPherson, Gladys ; Montgomery, Isobel ; Kilonzo, Mary ; Boyers, Dwayne ; Goulao, Beatriz ; Norrie, John. / Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial. In: Trials. 2016 ; Vol. 17. pp. 441.

@article{3a9f0b6a945449d6bc925b0a2b73776e,

title = "Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial",

abstract = "Background: One in three women who have a prolapse operation will go on to have another operation, though not necessarily in the same compartment. Surgery can result in greater impairment of quality of life than the original prolapse itself (such as the development of new-onset urinary incontinence, or prolapse at a different site). Anterior and posterior prolapse surgery is most common (90 % of operations), but around 43 % of women also have a uterine (34 %) or vault (9 %) procedure at the same time. There is not enough evidence from randomised controlled trials (RCTs) to guide management of vault or uterine prolapse. The Vault or Uterine prolapse surgery Evaluation (VUE) study aims to assess the surgical management of upper compartment pelvic organ prolapse (POP) in terms of clinical effectiveness, cost-effectiveness and adverse events.",

keywords = "pelvic organ prolapse, randomised controlled trials, study protocol ",

author = "Cathryn Glazener and Lynda Constable and Christine Hemming and Suzanne Breeman and Andrew Elders and Kevin Cooper and Robert Freeman and Smith, {Anthony R.B.} and Suzanne Hagen and Alison McDonald and Gladys McPherson and Isobel Montgomery and Mary Kilonzo and Dwayne Boyers and Beatriz Goulao and John Norrie",

note = "Found via WoS search Accepted: 5 August 2016 Online pub: 8 September 2016 Gold OA Funding note: The VUE Study is funded by the National Institute for Health Research Health Technology Assessment programme (project number 11/129/183).",

year = "2016",

month = sep,

doi = "10.1186/s13063-016-1576-x",

language = "English",

volume = "17",

pages = "441",

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Glazener, C, Constable, L, Hemming, C, Breeman, S, Elders, A, Cooper, K, Freeman, R, Smith, ARB, Hagen, S, McDonald, A, McPherson, G, Montgomery, I, Kilonzo, M, Boyers, D, Goulao, B & Norrie, J 2016, 'Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial', Trials, vol. 17, pp. 441. https://doi.org/10.1186/s13063-016-1576-x

Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial. / Glazener, Cathryn; Constable, Lynda; Hemming, Christine; Breeman, Suzanne; Elders, Andrew; Cooper, Kevin; Freeman, Robert; Smith, Anthony R.B.; Hagen, Suzanne; McDonald, Alison; McPherson, Gladys; Montgomery, Isobel; Kilonzo, Mary; Boyers, Dwayne; Goulao, Beatriz; Norrie, John.

In: Trials, Vol. 17, 09.2016, p. 441.

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

TY - JOUR

T1 - Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial

AU - Glazener, Cathryn

AU - Constable, Lynda

AU - Hemming, Christine

AU - Breeman, Suzanne

AU - Elders, Andrew

AU - Cooper, Kevin

AU - Freeman, Robert

AU - Smith, Anthony R.B.

AU - Hagen, Suzanne

AU - McDonald, Alison

AU - McPherson, Gladys

AU - Montgomery, Isobel

AU - Kilonzo, Mary

AU - Boyers, Dwayne

AU - Goulao, Beatriz

AU - Norrie, John

N1 - Found via WoS search Accepted: 5 August 2016 Online pub: 8 September 2016 Gold OA Funding note: The VUE Study is funded by the National Institute for Health Research Health Technology Assessment programme (project number 11/129/183).

PY - 2016/9

Y1 - 2016/9

N2 - Background: One in three women who have a prolapse operation will go on to have another operation, though not necessarily in the same compartment. Surgery can result in greater impairment of quality of life than the original prolapse itself (such as the development of new-onset urinary incontinence, or prolapse at a different site). Anterior and posterior prolapse surgery is most common (90 % of operations), but around 43 % of women also have a uterine (34 %) or vault (9 %) procedure at the same time. There is not enough evidence from randomised controlled trials (RCTs) to guide management of vault or uterine prolapse. The Vault or Uterine prolapse surgery Evaluation (VUE) study aims to assess the surgical management of upper compartment pelvic organ prolapse (POP) in terms of clinical effectiveness, cost-effectiveness and adverse events.

AB - Background: One in three women who have a prolapse operation will go on to have another operation, though not necessarily in the same compartment. Surgery can result in greater impairment of quality of life than the original prolapse itself (such as the development of new-onset urinary incontinence, or prolapse at a different site). Anterior and posterior prolapse surgery is most common (90 % of operations), but around 43 % of women also have a uterine (34 %) or vault (9 %) procedure at the same time. There is not enough evidence from randomised controlled trials (RCTs) to guide management of vault or uterine prolapse. The Vault or Uterine prolapse surgery Evaluation (VUE) study aims to assess the surgical management of upper compartment pelvic organ prolapse (POP) in terms of clinical effectiveness, cost-effectiveness and adverse events.

KW - pelvic organ prolapse

KW - randomised controlled trials

KW - study protocol

U2 - 10.1186/s13063-016-1576-x

DO - 10.1186/s13063-016-1576-x

M3 - Article

VL - 17

SP - 441

JO - Trials

JF - Trials

SN - 1745-6215

ER -