Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study
Women's Apical Pelvic Organ Prolapse Treatment - a Randomized Controlled Trial Comparing Transvaginal and Laparoscopic Mesh Surgery
Helsinki University Central Hospital
318 participants
Jul 1, 2020
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Age over 18 years and capability to understand the study protocol either in Finnish or Swedish.
- Objectively diagnosed symptomatic apical prolapse (leading apical prolapse (points C/D) ≥ -2) and a history of previous POP operation including hysterectomy.
- No need for any other concomitant operations except colporrhaphies and possible prophylactic salpingo-oophorectomy in CSP groups
Exclusion Criteria4
- A history of serious or prolonged pain after any operation or current or previous prolonged (over 6 months) pain of any reason.
- BMI over 40
- Regular use of systemic corticosteroid medication.
- Incapability to understand the study protocol.
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Interventions
Transvaginal mesh operation using BSC mesh (A.M.I., Feldkirch, Austria)
Colposacropexy using EndoGYNious mesh (A.M.I., Feldkirch, Austria)
Locations(1)
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NCT04478747