Status:
RECRUITING
Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study
Lead Sponsor:
Helsinki University Central Hospital
Conditions:
Prolapse, Vaginal Vault
Eligibility:
FEMALE
18-99 years
Phase:
NA
Brief 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 tw...
Detailed Description
Pelvic organ prolapse (POP) is defined as an anatomical support defect of the pelvic viscera. Women's POP is the descent of uterus or vaginal apex with or without concomitant descent of the anterior (...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2032
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT04478747
Start Date
July 1 2020
End Date
December 1 2032
Last Update
September 24 2025
Active Locations (1)
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1
Helsinki Naistenklinikka
Helsinki, Finland