Abdominal sacrocolpopexy failure rate rates increased over time in women who underwent abdominal sacrocolpopexy plus Burch urethropexy, as well as in women who underwent abdominal sacrocolpopexy alone. A 7-year follow-up study found that urethropexy prevented stress urinary incontinence longer than no urethropexy. Surgical prevention of stress urinary incontinence at the time of urethropexy appeared to involve no clinically significant trade-offs.
Ingrid Nygaard, MD, from the University of Utah School of Medicine in Salt Lake City, and colleagues published the results of their long-term follow-up in the May 15 issue of JAMA. The surgeries included in the study were performed by 21 surgeons from 7 sites between 2002 and 2005. The study was randomized, and both participants and outcomes assessors were masked.
"This study has important clinical implications and calls into question the designation of the abdominal sacrocolpopexy as the criterion standard procedure for prolapse repair," writes Cheryl B. Iglesia, MD, from Georgetown University School of Medicine, Washington, DC, in an accompanying editorial. "Although the stringent criteria used to define clinical success in this study and the use of blinded assessors likely account for the high failure rates for composite outcomes, only 5% of patients underwent repeat surgery for prolapse."
"We were surprised by the magnitude of treatment failure rates after abdominal sacrocolpopexy," the study's authors note. The lower success rate may in part be explained by the rigor of our data collection, with unbiased outcome assessment and use of validated outcome measures, or by nonstandardized aspects of surgical technique. In addition, knowledge about the natural history of [pelvic organ prolapse (POP)] would allow us to further refine our concepts of surgical failure vs progression of underlying POP disorder."
"It doesn't look like the best results, and I would have liked them to be better," Marie Paraiso, MD, from the Cleveland Clinic in Ohio, told Medscape Medical News in an interview. Dr. Paraiso was not affiliated with the study.
Women with POP receive approximately 225,000 surgeries a year in the United States. Although abdominal sacrocolpopexy does tend to provide relief of symptoms of POP, the authors found that by 5 years, nearly a third of women experience anatomic failure after the surgery
"Based on our results, women considering abdominal sacrocolpopexy should be counseled that this procedure effectively provides relief from POP symptoms; however, the anatomic support deteriorates over time," the authors write.
The researchers found that abdominal sacrocolpopexy is less effective than desired as a surgical treatment of POP. In addition, the complications related to synthetic mesh continue to reveal themselves over time. The probability of mesh erosion at 7 years was 10.5% (95% confidence interval, 6.8% - 16.1%).
The authors emphasize, however, that the types, size, and configurations of mesh are likely to influence success rates. Mesh brings with it both the likelihood of greater success and the probability of more complications.
"We anticipate that continued research in mesh development will lead to new materials and applications with fewer adverse events, but our data highlight the importance of careful long-term evaluation of new devices. Comparative effectiveness trials with long-term follow-up of at least 5 years are needed to compare abdominal sacrocolpopexy that we described in this report with vaginal prolapse procedures that include and do not include mesh augmentation," the authors write.
The authors conclude that the long-term risk for mesh or suture erosion should be balanced against the efficacy of abdominal sacrocolpopexy. Of note is the fact that some sites in the study did not receive renewed funding from the National Institutes of Health and therefore were not included in the extension of the Colpoplexy and Urinary Reduction Efforts study.
This research was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Office of Research on Women's Health at the National Institutes of Health. One coauthor reported serving as a consultant to Johnson & Johnson and Key Tech. One coauthor reported receiving research grants from Pelvalon, Astellas, University of California/Pfizer, Pfizer, and Warner Chilcott and serving as a consultant to Astellas (advisory board), GlaxoSmithKline, Uromedica, IDEO, Pfizer, and Xanodyne. One coauthor reported serving as a consultant to Intuitive Surgical. Dr. Iglesia reported serving as a consultant to the US Food and Drug Administration on a mesh panel in September 2011. The other authors and Dr. Paraiso have disclosed no relevant financial relationships.
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Cite this: Incontinence Risk Remains High After Burch Procedure - Medscape - May 14, 2013.