Major Finding: After an average 14.7 months of follow-up in a study of 65 women, 96% of women undergoing mesh colpopexy and 92% of women undergoing vaginal colpopexy without mesh were free of bulge symptoms, a difference that was not significant. The vaginal mesh erosion rate was relatively high at 15.6%.
Data Source: Randomized, double-blind, controlled trial of 65 women with pelvic organ prolapse stages 2–4.
Disclosures: The study was supported by research grants from the AUGS Foundation and the MedStar Health Research Institute. Ethicon Women's Health and Urology donated the Prolift mesh kits for this study. Dr. Sokol said he had no conflicts of interest.
LONG BEACH, CALIF. – A randomized controlled trial found no advantage for vaginal prolapse repair using mesh colpopexy compared with no-mesh repair, said Dr. Andrew I. Sokol of Washington (D.C.) Hospital Center.
After an average follow-up of 14.7 months in this study of 65 women, 96% of women undergoing mesh colpopexy with Prolift (Ethicon Women's Health and Urology) and 92% of women undergoing vaginal colpopexy without mesh were free of bulge symptoms; 25% of the mesh group and 22% of the no-mesh group experienced recurrent prolapse beyond the hymen. Neither of these differences was significant.
A total of 38% of women in the mesh group, compared with 30% of women in the no-mesh group, achieved optimal scores (stage 1 or below) on the pelvic organ prolapse quantification (POP-Q) scale, a difference that was not significant. On the other hand, the vaginal mesh erosion rate was relatively high at 15.6%, and the data safety monitoring board (DSMB) terminated the study early because of this, Dr. Sokol said.
In addition, there were three reoperations for erosion and three reoperations for prolapse among patients in the mesh group, compared with no reoperations in the no-mesh group, a significant difference.
In October 2008 the Food and Drug Administration issued a formal notification on reported complications from mesh use. Recognizing the high complication rate, mesh manufacturers have developed lighter-weight and mixed composite meshes. They have also developed trocarless mesh kits to minimize risks of visceral injury and groin pain, Dr. Sokol said. But long-term data are not yet available on these products.
The study included 65 women who were at POP-Q stages 2–4 uterovaginal or vaginal prolapse and who desired vaginal reconstructive surgery; the mean age in both groups was 64 years. The patients were randomized in the operating room after they had received anesthesia, and the research staff and the patient were blinded to the treatment assignment.