TY  - BOOK
AU  - Gutman, Robert E
AU  - Iglesia, Cheryl B
AU  - Peterson, Joanna L
AU  - Sokol, Andrew I
AU  - Wang, Hong
TI  - Three-year outcomes of vaginal mesh for prolapse: a randomized controlled trial
SN  - 0029-7844
KW  - *Pelvic Organ Prolapse/su [Surgery]
KW  - *Surgical Mesh/ae [Adverse Effects]
KW  - Aged
KW  - Double-Blind Method
KW  - Dyspareunia/ep [Epidemiology]
KW  - Female
KW  - Follow-Up Studies
KW  - Humans
KW  - Middle Aged
KW  - Postoperative Complications/ep [Epidemiology]
KW  - Sexuality
KW  - United States/ep [Epidemiology]
KW  - Urinary Incontinence, Stress/ep [Epidemiology]
KW  - MedStar Health Research Institute
KW  - MedStar Washington Hospital Center
KW  - Obstetrics and Gynecology/Female Pelvic Medicine and Reconstructive Surgery
KW  - Comparative Study
KW  - Journal Article
KW  - Multicenter Study
KW  - Randomized Controlled Trial
KW  - Research Support, Non-U.S. Gov't
N1  - Available online from MWHC library: 1995 - present, Available in print through MWHC library: 1999 - 2006
N2  - CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00475540; 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; LEVEL OF EVIDENCE: : I; 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; OBJECTIVE: To present the 3-year outcomes of a double-blind, multicenter, randomized trial comparing vaginal prolapse repair with and without mesh; 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
UR  - http://dx.doi.org/10.1097/AOG.0b013e3182a49dac
ER  -