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New treatment option for Prolapse, Vaginal Vault
Official title Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study
ClinicalTrials.gov ID: NCT04478747
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- No need for any other concomitant operations except colporrhaphies and possible prophylactic salpingo-oophorectomy in CSP groups
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Helsinki, Finland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 99 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Helsinki, Finland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.