Comparing two surgical methods for pelvic organ prolapse in women
Official title: Women's Apical Pelvic Organ Prolapse Treatment - a Randomized Controlled Trial Comparing Transvaginal and Laparoscopic Mesh Surgery
Run by Helsinki University Central Hospital · NCT04478747 · Data updated 2026-11-12
This study is testing which surgery, transvaginal mesh or laparoscopic colposacropexy, works better for women with pelvic organ prolapse and how it affects their recovery and quality of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | Women only |
| Enrollment | 318 (estimated) |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 1 site (Helsinki) |
| Status | Recruiting |
| Started | July 1, 2020 |
| Main results expected | December 2031 |
| Study ends | December 2032 |
| Registry record updated | September 24, 2025 |
| Trial ID | NCT04478747 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women over 18 years old with symptomatic apical prolapse and a history of previous pelvic organ prolapse surgery.
✕Probably not a fit
Patients with a BMI over 40 or those with a history of prolonged pain after surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to compare the effectiveness of transvaginal mesh (TVM) and laparoscopic colposacropexy (CSP) in treating women with apical prolapse. Participants will be divided into sub-groups based on the type of mesh fixation used during the CSP procedure. The study will evaluate both subjective and objective outcomes, including surgical complications, pain, sexual satisfaction, and cost-effectiveness. The goal is to determine which surgical approach provides better results for patients suffering from this condition.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical options and outcomes for women with pelvic organ prolapse.
How similar studies have gone: Previous studies have shown varying success with similar surgical approaches, but this specific comparison is novel.
Who can join: the full rules
Show full inclusion / exclusion 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 other concomitant operations except colporrhaphies and possible prophylactic salpingo-oophorectomy in CSP groups Exclusion Criteria: * 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.
Where it's running
-
Helsinki Naistenklinikka
Helsinki, Finland Recruiting
Study contacts
- Study coordinator: Tomi Mikkola, Prof.
- Email: tomi.mikkola@hus.fi
- Phone: +358504271187
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.