Transvaginal Human Acellular Dermal Matrix for Prolapse Treatment
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-100
SponsorHospital Mutua de Terrassa
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 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Vaginal hysterectomy plus matrix reinforcement and sacrospinous fixation with Anchorsure® device
- Vaginal hysterectomy plus anterior colporrhaphy
- Vaginal hysterectomy plus sacrospinous fixation with Anchorsure® device
Treatment groups
90 Participants
are divided into 3 treatment groupsSponsors and collaborators
Hospital Mutua de Terrassa
Lead sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborator
Germans Trias i Pujol Hospital
Collaborator
Hospital Arnau de Vilanova
Collaborator
Source ClinicalTrials.gov