Clinical Research Directory

Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study

Sponsor: Helsinki University Central Hospital

Summary

The main objective of the study is to compare subjective efficacy of trans vaginal mesh and laparoscopic colposakropexy (CSP) in women with an apical prolapse. The CSP group is further divided into two sub-groups; one where the mesh fixation is only at the apical part of the vagina, and another where the fixation is also extended to the levator plane. The secondary outcomes are safety (peri- and post-surgery complications, pain, erosion), objective efficacy (simplified POP-Q), and re-operation rate. Subjective outcome also includes the assessment of sexual satisfaction. Cost-effectiveness is studied by comparing both direct costs and QALYs.

Official title: Women's Apical Pelvic Organ Prolapse Treatment - a Randomized Controlled Trial Comparing Transvaginal and Laparoscopic Mesh Surgery

Key Details

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Interventions

Locations (1)