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
UR - http://www.scopus.com/inward/record.url?scp=85084744633&partnerID=8YFLogxK
U2 - 10.1111/1471-0528.16197
DO - 10.1111/1471-0528.16197
M3 - Article
C2 - 32141709
VL - 127
SP - 1002
EP - 1013
JO - BJOG-An International Journal of Obstetrics and Gynaecology
JF - BJOG-An International Journal of Obstetrics and Gynaecology
SN - 1470-0328
IS - 8
ER -