Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT)

CMA Glazener; S Breeman; A Elders; C Hemming; K G Cooper; R M Freeman; ARB Smith; S Hagen; I Montgomery; M Kilonzo; D Boyers; A McDonald; G McPherson; G MacLennan; J Norrie; F M Reid; PROSPECT study group

doi:10.1111/1471-0528.16197

Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT)

CMA Glazener^* (Corresponding Author), S Breeman, A Elders, C Hemming, K G Cooper, R M Freeman, ARB Smith, S Hagen, I Montgomery, M Kilonzo, D Boyers, A McDonald, G McPherson, G MacLennan, J Norrie, F M Reid, PROSPECT study group

^*Corresponding author for this work

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Abstract

OBJECTIVE: To compare standard (native tissue) repair against synthetic mesh inlays or mesh kits.

DESIGN: Randomised controlled trial.

SETTING: 33 UK hospitals.

POPULATION: Women having surgery for recurrent prolapse.

METHODS: Women recruited using remote randomisation.

MAIN OUTCOME MEASURES: Prolapse symptoms, condition specific quality-of-life and serious adverse effects.

RESULTS: Mean Pelvic Organ Prolapse Symptom Score at 1 year was similar for each comparison (standard 6.6 versus mesh inlay 6.1, mean difference (MD) -0.41, 95% CI [-2.92 to 2.11]: standard 6.6 versus mesh kit 5.9, MD -1.21 [-4.13 to 1.72]) but the confidence intervals did not exclude a minimally important clinical difference. There was no evidence of difference in any other outcome measure at 1 or 2 years. Serious adverse events, excluding mesh exposure, were similar at 1 year (standard 7/55 [13%] versus mesh inlay 5/52 [10%], risk ratio [RR] 1.05, [0.66 to 1.68]: standard 3/25 [12%] versus mesh kit 3/46 [7%], RR 0.49, [0.11 to 2.16]). Cumulative mesh exposure rates over 2 years were 7/52 (13%) in the mesh inlay arm, of whom four women required surgical revision; and 4/46 in the mesh kit arm (9%) of whom two required surgical revision.

CONCLUSIONS: We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery. Although the sample size was too small to be conclusive, the results provide a substantive contribution to future meta-analysis.

Original language	English
Pages (from-to)	1002-1013
Number of pages	12
Journal	BJOG-An International Journal of Obstetrics and Gynaecology
Volume	127
Issue number	8
Early online date	6 Apr 2020
DOIs	https://doi.org/10.1111/1471-0528.16197
Publication status	Published - Jul 2020

Keywords

pelvic organ prolapse
repeat surgery
randomised controlled trial
sythentic mesh
Pelvic organ prolapse
synthetic mesh
PELVIC ORGAN PROLAPSE
TERMINOLOGY
VAGINAL WALL PROLAPSE
OUTCOMES
ICS JOINT REPORT

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© 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. https://creativecommons.org/licenses/by/4.0/
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Cathryn Glazener
- School of Medicine, Medical Sciences & Nutrition, Applied Health Sciences - Emeritus Professor
Person: Honorary

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Glazener, CMA., Breeman, S., Elders, A., Hemming, C., Cooper, K. G., Freeman, R. M., Smith, ARB., Hagen, S., Montgomery, I., Kilonzo, M., Boyers, D., McDonald, A., McPherson, G., MacLennan, G., Norrie, J., Reid, F. M., & PROSPECT study group (2020). Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT). BJOG-An International Journal of Obstetrics and Gynaecology, 127(8), 1002-1013. https://doi.org/10.1111/1471-0528.16197

Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery : randomised controlled trial (PROSPECT). / Glazener, CMA (Corresponding Author); Breeman, S; Elders, A; Hemming, C; Cooper, K G; Freeman, R M; Smith, ARB; Hagen, S; Montgomery, I; Kilonzo, M ; Boyers, D; McDonald, A; McPherson, G; MacLennan, G; Norrie, J; Reid, F M; PROSPECT study group.

In: BJOG-An International Journal of Obstetrics and Gynaecology, Vol. 127, No. 8, 07.2020, p. 1002-1013.

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

Glazener, CMA, Breeman, S, Elders, A, Hemming, C, Cooper, KG, Freeman, RM, Smith, ARB, Hagen, S, Montgomery, I, Kilonzo, M , Boyers, D, McDonald, A, McPherson, G, MacLennan, G, Norrie, J, Reid, FM & PROSPECT study group 2020, 'Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT)', BJOG-An International Journal of Obstetrics and Gynaecology, vol. 127, no. 8, pp. 1002-1013. https://doi.org/10.1111/1471-0528.16197

Glazener, CMA ; Breeman, S ; Elders, A ; Hemming, C ; Cooper, K G ; Freeman, R M ; Smith, ARB ; Hagen, S ; Montgomery, I ; Kilonzo, M ; Boyers, D ; McDonald, A ; McPherson, G ; MacLennan, G ; Norrie, J ; Reid, F M ; PROSPECT study group. / Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery : randomised controlled trial (PROSPECT). In: BJOG-An International Journal of Obstetrics and Gynaecology. 2020 ; Vol. 127, No. 8. pp. 1002-1013.

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title = "Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT)",

abstract = "OBJECTIVE: To compare standard (native tissue) repair against synthetic mesh inlays or mesh kits.DESIGN: Randomised controlled trial.SETTING: 33 UK hospitals.POPULATION: Women having surgery for recurrent prolapse.METHODS: Women recruited using remote randomisation.MAIN OUTCOME MEASURES: Prolapse symptoms, condition specific quality-of-life and serious adverse effects.RESULTS: Mean Pelvic Organ Prolapse Symptom Score at 1 year was similar for each comparison (standard 6.6 versus mesh inlay 6.1, mean difference (MD) -0.41, 95% CI [-2.92 to 2.11]: standard 6.6 versus mesh kit 5.9, MD -1.21 [-4.13 to 1.72]) but the confidence intervals did not exclude a minimally important clinical difference. There was no evidence of difference in any other outcome measure at 1 or 2 years. Serious adverse events, excluding mesh exposure, were similar at 1 year (standard 7/55 [13%] versus mesh inlay 5/52 [10%], risk ratio [RR] 1.05, [0.66 to 1.68]: standard 3/25 [12%] versus mesh kit 3/46 [7%], RR 0.49, [0.11 to 2.16]). Cumulative mesh exposure rates over 2 years were 7/52 (13%) in the mesh inlay arm, of whom four women required surgical revision; and 4/46 in the mesh kit arm (9%) of whom two required surgical revision.CONCLUSIONS: We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery. Although the sample size was too small to be conclusive, the results provide a substantive contribution to future meta-analysis.",

keywords = "pelvic organ prolapse, repeat surgery, randomised controlled trial, sythentic mesh, Pelvic organ prolapse, synthetic mesh, PELVIC ORGAN PROLAPSE, TERMINOLOGY, VAGINAL WALL PROLAPSE, OUTCOMES, ICS JOINT REPORT",

author = "CMA Glazener and S Breeman and A Elders and C Hemming and Cooper, {K G} and Freeman, {R M} and ARB Smith and S Hagen and I Montgomery and M Kilonzo and D Boyers and A McDonald and G McPherson and G MacLennan and J Norrie and Reid, {F M} and {PROSPECT study group}",

note = "Funding The project was funded by the National Institute for Health Research Health Technology Assessment Programme (Project Number 07/60/18). 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. Acknowledgements The authors wish to thank the women who participated in the PROSPECT study. We also thank Margaret MacNeil for her secretarial support and data management; Dawn McRae and Lynda Constable for their trial management support; the programming team in CHaRT, led by Gladys McPherson; members of the Project Management Group for their ongoing advice and support of the study; and the staff at the recruitment sites who facilitated the recruitment, treatment and follow up of study participants.",

year = "2020",

month = jul,

doi = "10.1111/1471-0528.16197",

language = "English",

volume = "127",

pages = "1002--1013",

journal = "BJOG-An International Journal of Obstetrics and Gynaecology",

issn = "1470-0328",

publisher = "John Wiley & Sons, Ltd (10.1111)",

number = "8",

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TY - JOUR

T1 - Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery

T2 - randomised controlled trial (PROSPECT)

AU - Glazener, CMA

AU - Breeman, S

AU - Elders, A

AU - Hemming, C

AU - Cooper, K G

AU - Freeman, R M

AU - Smith, ARB

AU - Hagen, S

AU - Montgomery, I

AU - Kilonzo, M

AU - Boyers, D

AU - McDonald, A

AU - McPherson, G

AU - MacLennan, G

AU - Norrie, J

AU - Reid, F M

AU - PROSPECT study group

N1 - Funding The project was funded by the National Institute for Health Research Health Technology Assessment Programme (Project Number 07/60/18). 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. Acknowledgements The authors wish to thank the women who participated in the PROSPECT study. We also thank Margaret MacNeil for her secretarial support and data management; Dawn McRae and Lynda Constable for their trial management support; the programming team in CHaRT, led by Gladys McPherson; members of the Project Management Group for their ongoing advice and support of the study; and the staff at the recruitment sites who facilitated the recruitment, treatment and follow up of study participants.

PY - 2020/7

Y1 - 2020/7

N2 - OBJECTIVE: To compare standard (native tissue) repair against synthetic mesh inlays or mesh kits.DESIGN: Randomised controlled trial.SETTING: 33 UK hospitals.POPULATION: Women having surgery for recurrent prolapse.METHODS: Women recruited using remote randomisation.MAIN OUTCOME MEASURES: Prolapse symptoms, condition specific quality-of-life and serious adverse effects.RESULTS: Mean Pelvic Organ Prolapse Symptom Score at 1 year was similar for each comparison (standard 6.6 versus mesh inlay 6.1, mean difference (MD) -0.41, 95% CI [-2.92 to 2.11]: standard 6.6 versus mesh kit 5.9, MD -1.21 [-4.13 to 1.72]) but the confidence intervals did not exclude a minimally important clinical difference. There was no evidence of difference in any other outcome measure at 1 or 2 years. Serious adverse events, excluding mesh exposure, were similar at 1 year (standard 7/55 [13%] versus mesh inlay 5/52 [10%], risk ratio [RR] 1.05, [0.66 to 1.68]: standard 3/25 [12%] versus mesh kit 3/46 [7%], RR 0.49, [0.11 to 2.16]). Cumulative mesh exposure rates over 2 years were 7/52 (13%) in the mesh inlay arm, of whom four women required surgical revision; and 4/46 in the mesh kit arm (9%) of whom two required surgical revision.CONCLUSIONS: We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery. Although the sample size was too small to be conclusive, the results provide a substantive contribution to future meta-analysis.

AB - OBJECTIVE: To compare standard (native tissue) repair against synthetic mesh inlays or mesh kits.DESIGN: Randomised controlled trial.SETTING: 33 UK hospitals.POPULATION: Women having surgery for recurrent prolapse.METHODS: Women recruited using remote randomisation.MAIN OUTCOME MEASURES: Prolapse symptoms, condition specific quality-of-life and serious adverse effects.RESULTS: Mean Pelvic Organ Prolapse Symptom Score at 1 year was similar for each comparison (standard 6.6 versus mesh inlay 6.1, mean difference (MD) -0.41, 95% CI [-2.92 to 2.11]: standard 6.6 versus mesh kit 5.9, MD -1.21 [-4.13 to 1.72]) but the confidence intervals did not exclude a minimally important clinical difference. There was no evidence of difference in any other outcome measure at 1 or 2 years. Serious adverse events, excluding mesh exposure, were similar at 1 year (standard 7/55 [13%] versus mesh inlay 5/52 [10%], risk ratio [RR] 1.05, [0.66 to 1.68]: standard 3/25 [12%] versus mesh kit 3/46 [7%], RR 0.49, [0.11 to 2.16]). Cumulative mesh exposure rates over 2 years were 7/52 (13%) in the mesh inlay arm, of whom four women required surgical revision; and 4/46 in the mesh kit arm (9%) of whom two required surgical revision.CONCLUSIONS: We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery. Although the sample size was too small to be conclusive, the results provide a substantive contribution to future meta-analysis.

KW - pelvic organ prolapse

KW - repeat surgery

KW - randomised controlled trial

KW - sythentic mesh

KW - Pelvic organ prolapse

KW - synthetic mesh

KW - PELVIC ORGAN PROLAPSE

KW - TERMINOLOGY

KW - VAGINAL WALL PROLAPSE

KW - OUTCOMES

KW - ICS JOINT REPORT

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DO - 10.1111/1471-0528.16197

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VL - 127

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JO - BJOG-An International Journal of Obstetrics and Gynaecology

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Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT)

Abstract

Keywords

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Cathryn Glazener

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