Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study
Recruiting
N/A
Interventional Study
Prolapse, Vaginal Vault
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 99
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 318 (estimated)
- Sponsor
- Helsinki University Central Hospital · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 oth…
Contacts