The Comparison of Outcomes of Transvaginal Mesh Surgery with and without Midline Fascial Plication for the Treatment of Anterior Vaginal Prolapse: A Randomized Controlled Trial.

The aim of this study was to compare the clinical outcomes of transvaginal mesh (TVM) surgery with and without midline fascial plication for anterior prolapse repair. This is a prospective randomized trial in a teaching hospital. This study compared patients with anterior vaginal wall prolapse (POP-Q Ba > -1) who were randomly assigned to either transvaginal mesh (TVM, Avaulta SoloTM, CR Bard. Inc., Covington, GA, USA polypropylene mesh delivery system) (group A, n = 32) or TVM with concomitant midline fascial plication (group B, n = 32). The outcomes of anatomy correction and life quality were evaluated using a pelvic organ prolapse quantification system and questionnaires. Sixty-four patients were included from January 2011 through April 2014 in this study. Group A had a mean age of 63.7 years and a body mass index (BMI) of 25.4 kg/m2. Group B had a mean age of 62.9 years and a BMI of 25.4. The mean follow-up duration was 18.6 months (range 12-50). At the 12-month follow-up, anatomic recurrence was higher in Group A (5/31, 16.1%) than in Group B (1/30, 3.3%) but without statistical significance (p = 0.19). Improvements in symptoms and quality of life were not significantly different between the two groups. Mesh extrusion was detected in three of 61 patients (4.9%): two from group A (6.7%) and one from Group B (3.2%). TVM with concomitant midline fascia repair for anterior vaginal prolapse had a comparable anterior support and mesh exposure rate compared with TVM alone. Trial Registration: IRB-B09904021.

RCT Entities:   Population Interventions Outcomes