Prospective randomized trial of polyglactin 910 mesh to prevent recurrence of cystoceles and rectoceles.

OBJECTIVE: Our aim was to evaluate the efficacy of polyglactin 910 mesh in preventing recurrent cystoceles and rectoceles. STUDY
DESIGN: In a prospective, randomized, controlled trial, patients undergoing vaginal reconstructive surgery with cystoceles to the hymenal ring and beyond were randomly selected to undergo anterior and posterior colporrhaphy with or without polyglactin 910 mesh reinforcement. Results were evaluated preoperatively and at 2, 6, 12, and 52 weeks postoperatively.
RESULTS: A total of 161 women were randomly selected for this study. One woman was excluded at the time of surgery, and 17 women were lost to follow-up. Eighty women received mesh, and 80 did not. Both groups were found to be equivalent with respect to age, parity, concomitant surgery, and menopausal and hormone replacement status. Preoperatively 49 women had a central cystocele to the hymenal ring and 111 women had cystoceles beyond the introitus; 91 women had a rectocele to the mid-vaginal plane, 31 to the hymenal ring, and 22 beyond the introitus. After 1 year, 30 (43%) of 70 subjects without mesh and 18 (25%) of 73 subjects with mesh had recurrent cystoceles beyond the mid-vaginal plane (P =.02). Eight women without mesh and 2 women with mesh had recurrent cystoceles to the hymenal ring (P =.04). No recurrent cystoceles beyond the hymenal ring occurred in either group. Multivariate logistic regression analysis showed concurrent slings to be associated with significantly fewer recurrent cystoceles (odds ratio, 0.32; P =.005), whereas the presence of mesh remained significantly predictive of fewer cystocele recurrences in this analysis. Thirteen recurrent rectoceles were noted 1 year postoperatively, with no differences between groups.
CONCLUSION: Polyglactin 910 mesh was found to be useful in the prevention of recurrent cystoceles.

RCT Entities:   Population Interventions Outcomes