The primary aim of this double-blind, multicenter randomized clinical trial was to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for pelvic organ prolapse compared to traditional vaginal reconstructive surgery without mesh.
MATERIALS AND METHODS:
64 women with stage 2–4 prolapse were randomized to vaginal colpopexy repair with Prolift mesh or traditional vaginal colpopexy without mesh. The primary outcome measure was objective treatment success (POP-Q points Ba, Bp, or C at stage 1 or less) at 3 months and 1 year. Interim analysis was conducted after 56 subjects had approximately 3 months of follow-up or more. Mann-Whitney and log-rank test were used for statistical analysis.
At a mean follow-up of 7.2 months (range 2.1–14.7 months), the trial was halted due to pre-determined criteria for mesh erosion. 32 subjects underwent mesh colpopexy (23 anterior Prolift, 9 total Prolift), and 32 subjects had traditional vaginal repairs and colpopexies with no mesh (primarily uterosacral ligament suspension and colporrhaphy). There were no statistically significant differences between the mesh and no-mesh groups with respect to age (mean 64 years), race (64.1% Caucasian), BMI (mean 27.3), menopausal status (93.8%), and prior hysterectomy (40.6%). Analysis of the 29 mesh and 27 no-mesh subjects found no statistically significant difference with respect to overall recurrence. Thirteen (44.8%) of the mesh subjects and 19 (70.4%) of the no-mesh subjects had prolapse recurrence (P = 0.30). Most recurrences involved the anterior compartment (11 mesh subjects and 18 no-mesh subjects). Overall recurrence was sooner for the patients with prior hysterectomy, although the difference was not statistically significant. The median time to recurrence was 12.2 months for the concurrent hysterectomy group and 3.9 months for the prior hysterectomy group (P = 0.15). There were no statistically significant differences between the mesh and no-mesh groups with respect to the most recent postoperative POP-Q C or Bp measurements. However, the Ba measurements for the mesh group were smaller (see Table 1).
Of the 32 mesh patients, 5 (15.6%) developed vaginal mesh erosions, 1 in the group undergoing concomitant hysterectomy and 4 in the prior hysterectomy group (P = 0.077). Two cystotomies and one blood transfusion occurred in the mesh group only. Subjective QoL measurements did not differ significantly between the two groups at baseline or 3 months postoperatively.
Synthetic polypropylene mesh use may have some benefit at point Ba; however, there is a high vaginal mesh erosion rate (15.6%) with no difference in over-all objective or subjective cure rates. This study questions the value of additive synthetic polypropylene mesh for vaginal prolapse repairs.