The use of transvaginal synthetic mesh for anterior vaginal wall prolapse repair: a randomized controlled trial

Abstract

Introduction and hypothesisThe aim of the study was to compare the efficacy and safety of transvaginal trocar-guided polypropylene mesh insertion with traditional colporrhaphy for treatment of anterior vaginal wall prolapse.MethodsThis is a randomized controlled trial in which women with advanced anterior vaginal wall prolapse, at least stage II with Ba ≥ +1 cm according to the Pelvic Organ Prolapse Quantification (POP-Q) classification, were randomly assigned to have either anterior colporrhaphy (n = 39) or repair using trocar-guided transvaginal mesh (n = 40). The primary outcome was objective cure rate of the anterior compartment (point Ba) assessed at the 12-month follow-up visit, with stages 0 and I defined as anatomical success. Secondary outcomes included quantification of other vaginal compartments (POP-Q points), comparison of quality of life by the prolapse quality of life (P-QOL) questionnaire, and complication rate between the groups after 1 year. Study power was fixed as 80 % with 5 % cutoff point (p < 0.05) for statistical significance.ResultsThe groups were similar regarding demographic and clinical preoperative parameters. Anatomical success rates for colporrhaphy and repair with mesh placement groups were 56.4 vs 82.5 % (95 % confidence interval 0.068–0.54), respectively, and the difference between the groups was statistically significant (p = 0.018). Similar total complication rates were observed in both groups, with tape exposure observed in 5 % of the patients. There was a significant improvement in all P-QOL domains as a result of both procedures (p < 0.001), but they were not distinct between groups (p > 0.05).ConclusionsTrocar-guided transvaginal synthetic mesh for advanced anterior POP repair is associated with a higher anatomical success rate for the anterior compartment compared with traditional colporrhaphy. Quality of life equally improved after both techniques. However, the trial failed to detect differences in P-QOL scores and complication rates between the groups.

Treatment of anterior vaginal wall prolapse with and without polypropylene mesh: a prospective, randomized and controlled trial - Part I

“…Only one patient (2.3%) was submitted to partial resection of the exposed mesh and primary suture of the vaginal margins. These data are in accordance to the literature, that range from 5 to 15% (17,19,21,22). The main limit of the present study was that it was performed in a single center and did not have an independent examiner during objective evaluations at the postoperatory period.…”

“…It was observed success rate of 55% of the anterior colporraphy group versus 87% of the mesh group, but both groups showed improvement of urinary and POP symptoms. Delroy et al (19) in a prospective, controlled and randomized trial treated women with AVWP using the same kit of the present study and showed an anatomical success (Point Ba < -1) in 82.5% in group Mesh and 56.4% in Control group at 12-month follow-up. The NNT was 4.…”

The effectiveness of a pre-pubic four-arm NAZCA-TC mesh in treating cystocele and stress urinary incontinence simultaneously — results controlled with a pelvic floor ultrasound. A preliminary study

“…Only two of them (6.5%) report treatment failure after 12 months follow-up [12]. In the study of Delroy et al 79 women underwent either a classic anterior repair or a method using NAZCA TC but urinary incontinence was not analyzed in that study [35]. In our population in turn, the objective cure rate from SUI was 33%.…”

“…Urinary tract infections (UTI's) were noticed by 20% of patients. A statistically significant improvement was observed in all compartments but additional procedure for posterior or central compartment in more than 50% of women had to be performed [12,35].…”

Diagnosis and Therapy of Female Pelvic Organ Prolapse. Guideline of the DGGG, SGGG and OEGGG (S2e-Level, AWMF Registry Number 015/006, April 2016)

“…In studies with apical fixation or concomitant apical surgery [71][72][73][74][75][76][77][78][79], anterior repair using a synthetic mesh (excluding Prolift ® and Perigee ® ) had a cumulative success rate of 93 %; the cumulative success rate of studies without apical fixation or without standard apical surgery [80][81][82][83][84][85][86][87][88][89] was 83 %. The cumulative rate of mesh erosion was 8 % (137/1740); the cumulative rate for chronic pain and de novo dyspareunia was 7% (59/846).…”