NCT04478747 Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study
| NCT ID | NCT04478747 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Helsinki University Central Hospital |
| Condition | Prolapse, Vaginal Vault |
| Study Type | INTERVENTIONAL |
| Enrollment | 318 participants |
| Start Date | 2020-07-01 |
| Primary Completion | 2031-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 318 participants in total. It began in 2020-07-01 with a primary completion date of 2031-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04478747 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 99 Years, studying Prolapse, Vaginal Vault. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04478747 currently recruiting?
Yes, NCT04478747 is actively recruiting participants. Contact the research team at tomi.mikkola@hus.fi for enrollment information.
Where is the NCT04478747 trial being conducted?
This trial is being conducted at Helsinki, Finland.
Who is sponsoring the NCT04478747 clinical trial?
NCT04478747 is sponsored by Helsinki University Central Hospital. The trial plans to enroll 318 participants.