Using human acellular dermal matrix for treating pelvic organ prolapse in women
Transvaginal Human Acellular Dermal Matrix and Sacrospinous Fixation for Anterior and Apical Prolapse Treatment in Patients With Hiatal Ballooning or Levator Ani Injury: a Randomized Pilot Trial
This study is testing three different surgical options to see which one works best for women with pelvic organ prolapse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | Hospital Mutua de Terrassa Academic / other |
| Locations | 1 site (Terrassa) |
| Trial ID | NCT06404931 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of three surgical procedures for treating symptomatic anterior and apical prolapse in women. Participants will be randomly assigned to one of three groups: one receiving a classic vaginal hysterectomy with anterior colporrhaphy, another receiving a vaginal hysterectomy with human acellular dermal matrix reinforcement, and the last receiving vaginal hysterectomy with sacrospinous fixation alone. The study will assess anatomical severity and symptoms using validated questionnaires and 3D ultrasound imaging, with follow-ups scheduled at multiple intervals over three years to monitor outcomes and complications.
Who should consider this trial
Good fit: Ideal candidates are women over 18 with symptomatic anterior and apical prolapse who are eligible for vaginal surgical treatment.
Not a fit: Patients with previous pelvic floor surgery, chronic pelvic pain, or advanced prolapse (grade IV) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective surgical option for women suffering from pelvic organ prolapse.
How similar studies have performed: Other studies have shown promise in using acellular dermal matrices for surgical reinforcement, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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 and sign the informed consent. Exclusion Criteria: * 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 this trial is running
Terrassa
- Hospital Mutua de Terrassa — Terrassa, Spain (Recruiting)
Study contacts
- Study coordinator: Gerard Molina
- Phone: +34937365050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.