Robert E Gutman1, Patrick A Nosti, Andrew I Sokol, Eric R Sokol, Joanna L Peterson, Hong Wang, Cheryl B Iglesia. 1. Section of Female Pelvic Medicine and Reconstructive Surgery, Department of Women and Infants' Services, MedStar Washington Hospital Center/Georgetown University School of Medicine, Washington, DC; the Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, Stanford University School of Medicine, Stanford, California; and MedStar Health Research Institute, Hyattsville, Maryland.
Abstract
OBJECTIVE: To present the 3-year outcomes of a double-blind, multicenter, randomized trial comparing vaginal prolapse repair with and without mesh. METHODS: This was a planned final analysis of women with Pelvic Organ Prolapse Quantification (POP-Q) stage 2-4 prolapse randomized to traditional vaginal prolapse surgery without mesh and vaginal colpopexy repair with mesh. We evaluated anatomic, symptomatic, and combined cure rates for those with at least 3-year validated quality-of-life questionnaires and 2- or 3-year postoperative blinded POP-Q examination. Participants undergoing reoperation for recurrent prolapse were removed for anatomic and subjective outcomes analysis and considered failures for combined outcomes analysis. RESULTS:Sixty-five women were enrolled (33 mesh, 32 no mesh) before the study was prematurely halted as a result of a 15.6% mesh exposure rate. At 3 years, 51 of 65 (78%) had quality-of-life questionnaires (25 mesh, 26 no mesh) and 41 (63%) had examinations. Three participants died, three required reoperation for recurrent prolapse (all in mesh group), and eight were lost to follow-up. No differences were observed between groups at 3 years for prolapse stage or individual prolapse points. Stage improved for each group (90% and 86%) from baseline to 3 years (P<.01). Symptomatic improvement was observed with no differences in scores between groups. Cure rates did not differ between groups using a variety of definitions, and anatomic cure was lowest for the anterior compartment. CONCLUSION: There was no difference in 3-year cure rates when comparing patients undergoing traditional vaginal prolapse surgery without mesh with those undergoing vaginal colpopexy repair with mesh. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00475540. LEVEL OF EVIDENCE: : I.
RCT Entities:
OBJECTIVE: To present the 3-year outcomes of a double-blind, multicenter, randomized trial comparing vaginal prolapse repair with and without mesh. METHODS: This was a planned final analysis of women with Pelvic Organ Prolapse Quantification (POP-Q) stage 2-4 prolapse randomized to traditional vaginal prolapse surgery without mesh and vaginal colpopexy repair with mesh. We evaluated anatomic, symptomatic, and combined cure rates for those with at least 3-year validated quality-of-life questionnaires and 2- or 3-year postoperative blinded POP-Q examination. Participants undergoing reoperation for recurrent prolapse were removed for anatomic and subjective outcomes analysis and considered failures for combined outcomes analysis. RESULTS: Sixty-five women were enrolled (33 mesh, 32 no mesh) before the study was prematurely halted as a result of a 15.6% mesh exposure rate. At 3 years, 51 of 65 (78%) had quality-of-life questionnaires (25 mesh, 26 no mesh) and 41 (63%) had examinations. Three participants died, three required reoperation for recurrent prolapse (all in mesh group), and eight were lost to follow-up. No differences were observed between groups at 3 years for prolapse stage or individual prolapse points. Stage improved for each group (90% and 86%) from baseline to 3 years (P<.01). Symptomatic improvement was observed with no differences in scores between groups. Cure rates did not differ between groups using a variety of definitions, and anatomic cure was lowest for the anterior compartment. CONCLUSION: There was no difference in 3-year cure rates when comparing patients undergoing traditional vaginal prolapse surgery without mesh with those undergoing vaginal colpopexy repair with mesh. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00475540. LEVEL OF EVIDENCE: : I.
Authors: Shunaha Kim-Fine; Danielle D Antosh; Ethan M Balk; Kate V Meriwether; Gregg Kanter; Alexis A Dieter; Mamta M Mamik; Meadow Good; Ruchira Singh; Alexandriah Alas; Mohamed Foda; David D Rahn; Rebecca G Rogers Journal: Int Urogynecol J Date: 2021-05-14 Impact factor: 2.894