Actively Recruiting
Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment
Led by Hospital Mutua de Terrassa · Updated on 2025-01-17
90
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
H
Hospital Mutua de Terrassa
Lead Sponsor
F
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with symptomatic pelvic organ prolapse (POP) indicated for vaginal surgery
- Women with hiatal ballooning or levator ani injury evaluated by 3D pelvic floor ultrasound
- Women aged 18 years or older
- Women willing to complete a 36-month follow-up
- Women who understand and accept the study procedures and sign informed consent
You will not qualify if you...
- Women with previous pelvic floor or prolapse surgery
- Women with pelvic organ prolapse grade IV
- Women with chronic pelvic pain
- Women unable to understand the study nature or procedures
- Women who do not sign the informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Mutua de Terrassa
Terrassa, Spain, 08221
Actively Recruiting
Research Team
G
Gerard Molina
CONTACT
P
Pilar Arcusa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here