Premium
Two‐years results of native tissue versus vaginal mesh repair in the treatment of anterior prolapse according to different success criteria: A randomized controlled trial
Author(s) -
Dias Márcia M.,
de A. Castro Rodrigo,
Bortolini Maria Augusta T.,
Delroy Carlos A.,
Martins Paulo C.F.,
Girão Manoel J.B.C.,
Sartori Marair G.F.
Publication year - 2016
Publication title -
neurourology and urodynamics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 90
eISSN - 1520-6777
pISSN - 0733-2467
DOI - 10.1002/nau.22740
Subject(s) - medicine , randomized controlled trial , surgery , quality of life (healthcare) , patient satisfaction , clinical endpoint , surgical mesh , uterine prolapse , hernia , nursing
Aims To compare efficacy and safety of the traditional colporraphy and transvaginal polypropylene mesh for the treatment of advanced anterior vaginal prolapse according to different success criteria in two‐year follow‐up. Methods In this randomized controlled trial, women with anterior prolapse stage II or greater, with Ba point ≥ +1 (POP‐Q quantification), were randomly assigned to have either anterior colporraphy (n = 43) or transvaginal mesh repair (n = 43). The primary outcome was to compare objective success rate under two success definitions: prolapse stage I (Ba < −1) and stage II (Ba < 0). Secondary outcomes included complications and prolapse symptoms, satisfaction and quality of life (QoL). Intention to treat was used for the primary endpoint and per protocol analysis for the secondary outcomes. Results The groups presented similar preoperative data. Thirty three patients from the colporraphy and 37 from the mesh groups completed two‐year follow‐up. Under Ba < −1 definition, success rate was 39.53% for both groups ( P = 1.00). Considering success as Ba < 0, analysis favored the mesh group by 23% (51.16% and 74.42%; 95% CI for difference: 3–43%; P = 0.022). Patients from the mesh group were more satisfied after two years (81.8% and 97.3% for colporraphy and mesh, respectively, 15.5% difference; 95% CI for difference 1–29%; P = 0.032). Both procedures similarly improved women's symptoms and QoL. Some complications were observed, one being a 13.5% mesh exposure rate. Conclusions Transvaginal synthetic mesh repair for advanced anterior vaginal prolapse provided higher anatomical success and satisfaction rates compared with traditional colporraphy. Both procedures equally improved quality of life. Neurourol. Urodynam. 35:509–514, 2016 . © 2015 Wiley Periodicals, Inc.