The current criterion standard for repair of pelvic organ prolapse (POP) is laparoscopic sacrocolpopexy performed with a synthetic graft incorporating polypropylene mesh. To reduce the risk of synthetic mesh-related complications such as graft erosion, some surgeons have used nonmeshed porcine dermis to augment vaginal prolapse repairs. At a follow-up of 2 to 5 years, the reported success rates for the nonmeshed dermis are 81% to 87% for vaginal repairs, but surgeons experience a higher failure rate when the material was used for sacrocolpopexy. In recent years, a meshed porcine dermis product has been available that has a much more favorable host response. It has been hypothesized that the more favorable host response with meshed dermis could provide better sacrocolpopexy outcomes than those reported for nonmeshed porcine dermis. Before widespread adoption of meshed porcine dermis, it must be directly compared in randomized trials with the current criterion standard, type 1 polypropylene mesh.
This double-blind, randomized controlled trial compared the objective and subjective surgical outcomes at 12 months after laparoscopic sacrocolpopexy performed with porcine dermis or type 1 polypropylene mesh. Study subjects were patients scheduled for laparoscopic sacrocolpopexy. Only the surgical team was aware of the particular graft material used for each patient; both the clinical research nurse and the patients were blinded as to which graft material was used. The primary outcome measure was objective anatomic cure, which was defined as no POP quantification (POP-Q) points stage 2 or greater at any postoperative interval within the 1-year study period. The primary secondary end point was clinical cure defined as any patient with a POP-Q point greater than zero, or point C less than or equal to −5, or any complaints of prolapse symptoms on Pelvic Floor Distress Inventory-20 or Pelvic Floor Impact Questionnaire, Short Form. Reoperation for prolapse was considered to be clinical failure.
There were no preoperative differences between the randomized groups: porcine (n = 57) and mesh (n = 58). At 12 months, the objective anatomic cure rates were similar in both groups (porcine: 80.7% vs synthetic mesh; 86.2%; P = 0.24). The clinical cure rates were also similar (porcine: 84.2% vs synthetic mesh: 89.7%; P = 0.96). Significant improvement was found in both groups for scores in the Pelvic Floor Distress Inventory-20 and Pelvic Floor Impact Questionnaire, Short Form 7, with no differences between groups. No major operative complications were noted.
These findings show similar subjective or objective outcomes 12 months after laparoscopic sacrocolpopexy performed with either porcine dermis or polypropylene mesh, suggesting that porcine dermis may be a suitable alternative to synthetic mesh.
Division of Urogynecology, Atlantic Health System, Morristown NJ; Department of Obstetrics, Gynecology and Reproductive Science, Mount Sinai School of Medicine, New York, NY; and Department of Mathematics and Statistics, Kennesaw State University, Kennesaw, GA