San Diego--In a comparison of sling materials for sacral colpopexy, polypropylene mesh met the challenge of solvent-dehydrated cadaveric fascia lata and demonstrated a statistically significant outcome advantage at 1 year, University of Louisville (KY) researchers reported.
San Diego-In a comparison of sling materials for sacral colpopexy, polypropylene mesh met the challenge of solvent-dehydrated cadaveric fascia lata and demonstrated a statistically significant outcome advantage at 1 year, University of Louisville (KY) researchers reported.
More than 90% of patients who received polypropylene mesh slings (Trelex, Boston Scientific, Natick, MA) had successful outcomes, compared with less than 70% of patients randomized to cadaveric fascia, said Patrick Culligan, MD, formerly director of urogynecology at the University of Louisville and currently director of urogynecology, Atlantic Health System, Morristown, NJ.
"We attained reasonably good outcomes with both materials, but there were significant differences in the anterior and apical POP-Q [pelvic organ prolapse quantification system] points at 1-year post-op. We were kind of surprised by the difference at 1 year, as defined by success or failure," Dr. Culligan said. "Our conclusions are that polypropylene mesh is superior to solvent-dehydrated cadaveric fascia lata in terms of the POP-Q points, POP-Q stage, and objective success rate."
'Ideal' graft material? The comparative trial arose from the ongoing search for an ideal graft material for reconstructive pelvic surgery, Dr. Culligan said at the American Urogynecologic Society/Society of Gynecologic Surgeons joint scientific meeting here. Although subjective in nature, the definition of an ideal graft material includes consistent strength, reasonable cost, permanence, minimal erosion, and restoration of functional anatomy, he said.
One-hundred patients presenting for sacral colpopexy were randomized on the day of surgery to receive either a mesh sling (54 patients) or cadaveric fascia lata (46). Regardless of treatment assignment, two pieces of material were placed anteriorly and posteriorly, and the assigned material covered a 4- to 6-cm anterior segment and a slightly larger posterior segment, Dr. Culligan said. The graft was attached to the anterior longitudinal ligament overlying the sacrum, using at least two sutures.
Follow-up assessments occurred at 6 weeks and then at 3, 6, and 12 months. The primary outcomes were POP-Q stage and POP-Q points over time. Surgical failure was defined as a POP-Q stage of 2 or greater at any assessment point.
At all time points, polypropylene mesh-treated patients had better POP-Q scores than the cadaveric fascia patients. The difference remained statistically significant at 1 year (p=.028).
Among 89 patients evaluable for treatment success or failure at 1 year, the success rates were 68.2% with the cadaveric fascia lata and 91.1% for the polypropylene mesh (p=.007). Results with the two materials did not differ with respect to genital hiatus, perineal body, or vaginal length.
Though surprising, the results could have been influenced by the definition of success used in the trial, Dr. Culligan said, adding that different criteria for success and failure might have led to different results.
Another factor that might have influenced the outcome was the loss of 11 patients not available for inclusion in the results, a point raised during discussion of the study. Assuming those patients would have all been "failures," the success rates would have been 76% for the mesh group and 65% for the cadaveric fascia lata.