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.
|Number of pages||12|
|Journal||BJOG-An International Journal of Obstetrics and Gynaecology|
|Early online date||6 Apr 2020|
|Publication status||Published - Jul 2020|
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.
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.
- pelvic organ prolapse
- repeat surgery
- randomised controlled trial
- sythentic mesh
- Pelvic organ prolapse
- synthetic mesh
- PELVIC ORGAN PROLAPSE
- VAGINAL WALL PROLAPSE
- ICS JOINT REPORT