Using human acellular dermal matrix for treating pelvic organ prolapse in women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Mutua de Terrassa
  Terrassa, Spain Recruiting

Study contacts

• Study coordinator: Gerard Molina
• Phone: +34937365050

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.