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
There is no difference in 3-year anatomic and symptomatic cure rates and satisfaction after traditional vaginal prolapse surgery without mesh and vaginal colpopexy with mesh.
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.
Corresponding author: Robert E. Gutman, MD, National Center for Advanced Pelvic Surgery, MedStar Washington Hospital Center, 106 Irving Street NW, Suite 405 S, Washington, DC 20010; e-mail: Robert.firstname.lastname@example.org.
Supported by a grant from the American Urogynecologic Society Foundation and the MedStar Health Research Institute Intramural Grant.
The authors thank Ethicon Women's Health and Urology (Somerville, NJ) for donating the Prolift mesh kits for this study.
Presented as an oral presentation at the Society of Gynecologic Surgeons Annual Meeting, April 8–10, 2013, Charleston, South Carolina.
Financial Disclosure Dr. Sokol has received grant funding from Contura, has been a clinical advisor to and holds stock options in Pelvilon, and has received consulting fees (new and not when the Vaginal Mesh for Prolapse [VAMP] study was done) from American Medical Systems. The other authors did not report any potential conflicts of interest.