Major Finding: Paravaginal repair of anterior prolapse with synthetic mesh was associated with a higher anatomic success rate than was xenograft repair, both of which beat standard colporrhaphy at 1 year after surgery.
Data Source: Interim results of a double-blind, randomized controlled study in 78 women with symptomatic prolapse.
Disclosures: The study was supported by an unrestricted grant from Boston Scientific Corp. Dr. Dyer and her coauthors said they had no relevant disclosures.
HOLLYWOOD, FLA. — Paravaginal repair of anterior prolapse with synthetic mesh is associated with a higher anatomic success rate than is xenograft repair; both of these interventions were more successful than standard colporrhaphy, based on interim results of a double-blind, randomized controlled study.
There were no significant differences in symptomatic prolapse recurrence, operative time, or sexual function outcomes, Dr. Keisha Dyer said.
Recurrence rates of up to 40%-50% are often reported after anterior vaginal wall prolapse repair, with about 30% of these women requiring a reoperation, she said.
Although paravaginal repairs and graft augmentation can decrease the number of failures, more good data are needed about the optimal material, said Dr. Dyer of the division of female pelvic medicine and reconstructive surgery at the University of California, San Diego.
Dr. Dyer and her associates assessed 99 women with symptomatic prolapse. In the operating room on the day of surgery, 32 were randomized to anterior colporrhaphy; another 31, to porcine dermal graft; and the remaining 36, to polypropylene mesh.
At baseline, patients enrolled in this Optimal Anterior Repair Study (OARS) had a mean of stage III anterior prolapse and a mean age of 63 years. They were enrolled from January 2006 to September 2008.
Dr. Dyer presented interim results for 78 women followed for at least 1 year (mean, 20 months) at the annual meeting of the American Urogynecologic Society.
Anatomic success was achieved by 14 of 26 women (54%) in the colporrhaphy group, 15 of 24 women (63%) in the porcine graft group, and 25 of 28 (89%) women in the synthetic mesh group. The difference in this primary outcome between the colporrhaphy and synthetic mesh groups was statistically significant, Dr. Dyer said. Anatomic success was defined as prolapse stage I or 0 on the Pelvic Organ Prolapse Quantification (POP-Q) examination.
There was no significant difference between groups in symptomatic recurrence, a secondary aim of the study. A total of 12% of the colporrhaphy group, 13% of the porcine graft group, and 4% of the mesh group had a return of prolapse symptoms, such as complaint of “bulge.” Two women had reoperations for symptomatic recurrence, both patients in the porcine graft group.
The erosion rate was higher in the synthetic mesh group. This outcome was experienced by four patients in this group (14%) compared with one patient (4%) who received the porcine graft repair.
There were no significant differences in terms of operative time. However, there was a trend toward approximately 50-mL more blood loss with augmentation, Dr. Dyer said. Estimated blood loss was 171 mL in the colporrhaphy cohort, 229 mL in the porcine graft group, and 225 mL in the synthetic mesh patients.
Postoperative sexual function scores on the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ) were not significantly different between groups.