Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment
Recruiting
Phase 2
Interventional Study
Prolapse; Female
Prolapse Genital
Prolapse Uterovaginal
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 100
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 90 (estimated)
- Sponsor
- Hospital Mutua de Terrassa · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 an…
Contacts
Gerard Molina
+34937365050
CONTACT
Pilar Arcusa
+34937365050
CONTACT