Related Experiment Video
Updated: May 7, 2026
Transvaginal Mesh Insertion in the Ovine Model
Published on: July 27, 2017
Three-year outcomes of vaginal mesh for prolapse: a randomized controlled trial
Robert E Gutman1, Patrick A Nosti, Andrew I Sokol
1Section 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.
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.
