Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment
Recruiting now · Phase 2
Conditions studied: Prolapse; Female, Prolapse Genital, Prolapse Uterovaginal
In brief
This is a randomised study in which we compare the effectiveness of three different procedures in mending symptomatic anterior and apical prolapse in patients who are candidates to receive surgery. They will be randomly assigned in a ratio 1:1:1 to three different groups who will have assigned three different kinds of surgery. In the patients of the first group a classic vaginal hysterectomy with anterior colporrhaphy will be practised. Patients who belong to group two will undergo a vaginal hysterectomy followed by placement of an acellular dermal matrix from cadaveric donors (hADM) for anterior reinforcement and sacrospinous fixation with Anchorsure® device (Neomedic trade mark (TM) International, Spain). Finally, patients from group three will have vaginal hysterectomy followed by sacrospinous fixation with Anchorsure® alone . Patients will be followed-up at 4 weeks, 6 months, 12 months and annually till 36 months to evaluate relapses and possible complications.
Key facts
- Study ID
- NCT06404931
- Run by
- Hospital Mutua de Terrassa
- People needed
- 90
- Starts
- 2024-07-01
- Expected to finish
- 2026-01-01
- Last updated by the study team
- 2025-01-17
Who can join
Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women with symptomatic POP with indication of vaginal surgery.
- Women with hiatal ballooning or levator ani injury evaluated by 3D pelvic floor ultrasound.
- Women ≥18 years old.
- Women wishing to complete a 36-month follow-up.
- Understand and accept the study procedures and sign the informed consent.
You may not qualify if…
- Women with previous pelvic floor or prolapse surgery
- Women with POP grade IV
- Women with chronic pelvic pain.
- Not being able to understand the nature of the study and/or the procedures to be followed.
- Not signing the informed consent
Where it is running
- Hospital Mutua de Terrassa — Terrassa, Spain (enrolling)
Full record on ClinicalTrials.gov
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