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 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.

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

“…We would like to thank Maher and Hartel for their interest 1 in our RCT evaluating the use of mesh inlay and mesh kits in women having repeat prolapse surgery (secondary, strictly defined as failure in the same compartment). 2 We value the opportunity to address some of their concerns. This trial was undertaken opportunistically alongside our RCT in women having their first (primary) repair.…”

How common are complications following polypropylene mesh, biological xenograft and native tissue surgery for pelvic organ prolapse? A secondary analysis from the PROSPECT trial

“…PROSPECT, one of the largest multicentre comprehensive cohort studies with an embedded randomised controlled trial comparing native tissue, biological xenograft and mesh for transvaginal repair of anterior and posterior compartment pelvic organ prolapse, revealed no significant differences in patient‐reported outcomes at 2 years. 5 , 6 , 7 Serious adverse effects, defined as causing death, requiring admission to hospital or prolongation of existing hospital admission, resulting in significant incapacity or disability, or otherwise considered important by the investigator were comparable across treatment groups.…”

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

“…reliability, validity and responsiveness, should be assessed and considered adequate. 2 The authors' citation supporting a 'valid' questionnaire 3 only addresses internal consistency, construct validity and sensitivity to change, with test-retest reliability and minimally important difference (responsiveness in a clinically meaningful way) of the questionnaire unaddressed in peer review literature. For this reason, the POPss was not included as a recommended questionnaire for assessment of prolapse in the 6th International Consultation on Incontinence 4 and should be described as a non-validated questionnaire and primary outcome.…”

“…We would like to thank Maher and Hartel for their interest 1 in our RCT evaluating the use of mesh inlay and mesh kits in women having repeat prolapse surgery (secondary, strictly defined as failure in the same compartment). 2 We value the opportunity to address some of their concerns.…”

“…We would like to congratulate the authors for undertaking this trial; 1 however, we have significant reservations regarding the study methodology and interpretation of the data.…”