Objective: To compare standard (native tissue) repair with synthetic mesh inlays or mesh kits. Design: Randomised controlled trial. Setting: Thirty-three 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: A 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, 95% CI −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 [0.66–1.68]: standard 3/25 [12%] versus mesh kit 3/46 [7%], RR 0.49 [0.11–2.16]). 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. Tweetable abstract: There is not enough evidence to support use of synthetic mesh inlay or mesh kits for repeat prolapse surgery.
|Number of pages||12|
|Journal||BJOG: An International Journal of Obstetrics and Gynaecology|
|Publication status||Published - 1 Jul 2020|
Bibliographical noteFunding Information:
Women listed for transvaginal repair of an anterior and/or posterior prolapse were eligible if at least one of the compartments requiring surgery had been repaired previously. Women could have concomitant uterine, vault or continence surgery. Women under the care of 59 gynaecologists from 33 UK centres were enrolled into the trial between January 2010 and August 2013. All women provided written informed consent. The study was funded by the National Institute for Health Research Health Technology Assessment Programme (Project Number 07/60/18). The funder (through their peer review and funding board review process) approved the study proposal but had no role in the collection, analysis or interpretation of data, or writing of the report.
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.
Mr Elders reports that his institution (Glasgow Caledonian University) received payment from the University of Aberdeen for statistical analysis undertaken by him. Prof. Norrie reports grants from the University of Aberdeen during the conduct of the study; grants from the University of Edinburgh during the conduct of the study; and Membership of the following NIHR boards: CPR decision‐making committee; HTA Commissioning Board; HTA Commissioning Sub‐Board (EOI); HTA Funding Boards Policy Group; HTA General Board; HTA Post‐Board funding teleconference; NIHR CTU Standing Advisory Committee; NIHR HTA & EME Editorial Board; Pre‐exposure Prophylaxis Impact Review Panel. All other authors report no conflict of interest. Completed disclosure of interest forms are available to view online as supporting information.
© 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
- Pelvic organ prolapse
- randomised controlled trial
- repeat surgery
- synthetic mesh