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Three-year outcomes of vaginal mesh for prolapse: a randomized controlled trial.

by Gutman, Robert E; Sokol, Andrew I; Peterson, Joanna L; Wang, Hong; Iglesia, Cheryl B.
Citation: Obstetrics & Gynecology. 122(4):770-7, 2013 Oct..Journal: Obstetrics and gynecology.ISSN: 0029-7844.Full author list: Gutman RE; Nosti PA; Sokol AI; Sokol ER; Peterson JL; Wang H; Iglesia CB.UI/PMID: 24084533.Subject(s): Aged | Double-Blind Method | Dyspareunia/ep [Epidemiology] | Female | Follow-Up Studies | Humans | Middle Aged | *Pelvic Organ Prolapse/su [Surgery] | Postoperative Complications/ep [Epidemiology] | Sexuality | *Surgical Mesh/ae [Adverse Effects] | United States/ep [Epidemiology] | Urinary Incontinence, Stress/ep [Epidemiology]Institution(s): MedStar Health Research Institute | MedStar Washington Hospital CenterDepartment(s): Obstetrics and Gynecology/Female Pelvic Medicine and Reconstructive SurgeryActivity type: Journal Article.Medline article type(s): Comparative Study | Journal Article | Multicenter Study | Randomized Controlled Trial | Research Support, Non-U.S. Gov'tOnline resources: Click here to access online Digital Object Identifier: http://dx.doi.org/10.1097/AOG.0b013e3182a49dac (Click here) Abbreviated citation: Obstet Gynecol. 122(4):770-7, 2013 Oct.Local Holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006.Abstract: OBJECTIVE: To present the 3-year outcomes of a double-blind, multicenter, randomized trial comparing vaginal prolapse repair with and without mesh.Abstract: 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.Abstract: 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.Abstract: 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.Abstract: CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00475540.Abstract: LEVEL OF EVIDENCE: : I.

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