PURPOSE: We compared the efficacy and safety of anterior colporrhaphy with transvaginal polypropylene mesh insertion for anterior vaginal wall prolapse at medium term followup. MATERIALS AND METHODS: In this prospective, randomized, controlled trial 100 women with stage II or greater anterior vaginal wall prolapse assessed by POP-Q were randomized to anterior colporrhaphy (controls) or mesh insertion. Anatomical outcomes were assessed by POP-Q measurement and prolapse stage. Subjective outcomes and quality of life impact were evaluated by ICIQ questionnaires. We evaluated the procedure safety profile according to intraoperative complication rates throughout followup. RESULTS: In the mesh and control groups 42 and 50 women completed the 24-month followup. Point Ba did not significantly differ between the groups at baseline but at 24-month followup it had significantly improved in the mesh group compared to controls. However, no difference was found between the groups when considering 2 cure criteria on prolapse stage and subjective parameters. Asymptomatic mesh exposure developed on the anterior vaginal wall prolapse in 7 patients (16.4%) in the mesh group. Minor mesh related complications consisted of mesh exposure, prepubic ecchymosis and groin pain, of which most were treated conservatively. Urinary retention was treated surgically. CONCLUSIONS:Nazca TC™ and anterior colporrhaphy provided good overall anatomical outcomes during a minimum 24-month followup. Vaginal and urinary symptoms, and quality of life improved postoperatively in each group. From the patient perspective Nazca TC did not show superior overall outcomes compared to anterior colporrhaphy performed with or without a retropubic sling.
RCT Entities:
PURPOSE: We compared the efficacy and safety of anterior colporrhaphy with transvaginal polypropylene mesh insertion for anterior vaginal wall prolapse at medium term followup. MATERIALS AND METHODS: In this prospective, randomized, controlled trial 100 women with stage II or greater anterior vaginal wall prolapse assessed by POP-Q were randomized to anterior colporrhaphy (controls) or mesh insertion. Anatomical outcomes were assessed by POP-Q measurement and prolapse stage. Subjective outcomes and quality of life impact were evaluated by ICIQ questionnaires. We evaluated the procedure safety profile according to intraoperative complication rates throughout followup. RESULTS: In the mesh and control groups 42 and 50 women completed the 24-month followup. Point Ba did not significantly differ between the groups at baseline but at 24-month followup it had significantly improved in the mesh group compared to controls. However, no difference was found between the groups when considering 2 cure criteria on prolapse stage and subjective parameters. Asymptomatic mesh exposure developed on the anterior vaginal wall prolapse in 7 patients (16.4%) in the mesh group. Minor mesh related complications consisted of mesh exposure, prepubic ecchymosis and groin pain, of which most were treated conservatively. Urinary retention was treated surgically. CONCLUSIONS: Nazca TC™ and anterior colporrhaphy provided good overall anatomical outcomes during a minimum 24-month followup. Vaginal and urinary symptoms, and quality of life improved postoperatively in each group. From the patient perspective Nazca TC did not show superior overall outcomes compared to anterior colporrhaphy performed with or without a retropubic sling.
Authors: Constantin M Durnea; Vasilios Pergialiotis; James M N Duffy; Lina Bergstrom; Abdullatif Elfituri; Stergios K Doumouchtsis Journal: Int Urogynecol J Date: 2018-10-22 Impact factor: 2.894