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Randomized Controlled Trial
. 2013 Nov;24(11):1899-907.
doi: 10.1007/s00192-013-2092-0. Epub 2013 Apr 30.

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

Carlos A Delroy  1 , Rodrigo de A Castro, Márcia M Dias, Paulo C Feldner Jr, Maria Augusta T Bortolini, Manoel J B C Girão, Marair G F Sartori
Affiliations
Randomized Controlled Trial

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

Carlos A Delroy et al. Int Urogynecol J. 2013 Nov.

Abstract

Introduction and hypothesis: The 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.

Methods: This 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.

Results: The 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).

Conclusions: Trocar-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.

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Figures

Fig. 1
Fig. 1
CONSORT diagram of participants. Note that data are available from the total cohort of randomized patients at the 1-year follow-up
Fig. 2
Fig. 2
Anatomical success defined as point Ba < −1. Values are given in % of patients that met the cure criteria from each group. Pearson’s chi-square test. A significant difference is indicated by *p < 0.05
See this image and copyright information in PMC

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