Actively Recruiting
Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study
Led by Helsinki University Central Hospital · Updated on 2025-09-24
318
Participants Needed
1
Research Sites
648 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years and ability to understand the study protocol in Finnish or Swedish
- Objectively diagnosed symptomatic apical prolapse with leading apical point (C/D) at or below -2
- History of previous pelvic organ prolapse surgery including hysterectomy
- No need for other surgeries except possible colporrhaphies or prophylactic salpingo-oophorectomy in CSP groups
You will not qualify if you...
- History of serious or prolonged pain after any operation or ongoing prolonged pain over 6 months
- Body mass index (BMI) over 40
- Regular use of systemic corticosteroid medication
- Inability to understand the study protocol
AI-Screening
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Trial Site Locations
Total: 1 location
1
Helsinki Naistenklinikka
Helsinki, Finland
Actively Recruiting
Research Team
T
Tomi Mikkola, Prof.
CONTACT
C
Camilla Isaksson, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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