A prospective, randomized, controlled study comparing Gynemesh, a synthetic mesh, and Pelvicol, a biologic graft, in the surgical treatment of recurrent cystocele.

We compared safety and efficacy of Gynemesh PS and Pelvicol for recurrent cystocele repair. One hundred ninety patients were randomly divided into Gynemesh PS and Pelvicol groups and underwent tension-free cystocele repair. The Chi-square test was used to compare categorical variables, the paired t test for continuous parametric variables, and the Mann-Whitney test for continuous nonparametric variables. Ninety-six Gynemesh PS patients and 94 Pelvicol patients were studied. Mesh erosions occurred in 6.3% of Gynemesh PS patients. No erosions were observed in Pelvicol patients (p = 0.02). Objective cure was 71.9% for Gynemesh PS and 56.4% for Pelvicol (p = 0.06). Subjective cure was the same in both groups except for better sexuality in the Pelvicol group. At 24 months follow-up, only Gynemesh PS patients had mesh erosions. Anatomical outcome was similar in the two groups. Pelvicol gave a better impact on voiding and sexuality.

RCT Entities:   Population Interventions Outcomes