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Clinical Trial
. 2011 Jan;204(1):74.e1-8.
doi: 10.1016/j.ajog.2010.08.036. Epub 2010 Oct 20.

Trocar-guided mesh repair of vaginal prolapse using partially absorbable mesh: 1 year outcomes

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Clinical Trial

Trocar-guided mesh repair of vaginal prolapse using partially absorbable mesh: 1 year outcomes

Alfredo L Milani et al. Am J Obstet Gynecol. 2011 Jan.

Abstract

Objective: To evaluate anatomic and functional outcomes at 1-year following trocar-guided transvaginal prolapse repair using a partially absorbable mesh.

Study design: Prospective multicentre cohort study at 11 international sites. One hundred twenty-seven patients with pelvic organ prolapse stage ≥ III had surgery and were evaluated at 3 months and 1-year postsurgery compared with baseline. Instruments of measurements: Pelvic Organ Prolapse Quantification, Pelvic Floor Distress Inventory-20, Pelvic Floor Impact Questionnaire-7, Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire-12, and Patients Global Impression of Change.

Results: Anatomic success, defined as prolapse stage ≤ I in the treated vaginal compartments, was 77.4% (95% confidence interval, 69.0-84.4%). Significant improvements in bother, quality of life, and sexual function were detected at 3 months and 1 year compared with baseline. At 1-year after surgery, 86.2% of patients indicated their prolapse situation to be "much better." Mesh exposure rate was 10.2% and rate of de novo dyspareunia 2% at 1 year.

Conclusion: These results demonstrate improved anatomic support, associated with excellent functional improvements, without apparent safety concerns.

Trial registration: ClinicalTrials.gov NCT00833001.

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