Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment

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.

NCT Number	NCT06404931
Lead Sponsor	Hospital Mutua de Terrassa Collaborators: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Germans Trias i Pujol Hospital, Hospital Arnau de Vilanova
Conditions	Prolapse; Female, Prolapse Genital, Prolapse Uterovaginal
Enrollment	90 participants
Start Date	2024-07-01
Primary Completion	2025-01-01 (estimated)
Study Completion	2026-01-01 (estimated)
Updated on ClinicalTrials.gov	2025-01-17