Comparing biological and synthetic mesh in pelvic prolapse surgery

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 prospective study evaluates the effectiveness of OviTex 1S, a biological mesh, against the standard polypropylene mesh in minimal-invasive ventral mesh rectopexy (VMR) and sacrocolporectopexy (SCR) procedures for pelvic prolapse. The study addresses the ongoing debate regarding the choice of mesh material, especially in light of recent FDA regulations affecting synthetic mesh. Participants will be randomly assigned to receive either type of mesh, and outcomes will be assessed for recurrence rates and graft-related complications. The goal is to provide high-quality evidence to guide clinical decisions in pelvic floor surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Indication for VMR or SCR set by the treating surgeon/gynecologist in accordance to the current guidelines on rectal and pelvic prolapse;
* Counselled for therapeutic options and given informed consent for VMR or SCR;
* Counselled for different types of mesh (OviTex or Prolene) and randomisation;
* Written informed consent for randomisation, OviTex implant or Prolene;
* Written informed consent for observational data collection.

Exclusion Criteria:

* Mentally incompetent patients (unable to fulfil questionnaires).
* Allergy to ovine rumen.
* A medical history of pelvic radiation therapy.
* Scheduled for a redo-rectopexy.
* A medical history of previously implanted pelvic floor meshes or native tissue.
* Language barrier

Where it's running

• Meander Medisch Centrum
  Amersfoort, Utrecht, Netherlands Recruiting

Study contacts

• Principal investigator: Esther Consten, Prof.dr — Meander Medisch Centrum
• Study coordinator: Marije Boom, drs.
• Email: ma.boom@meandermc.nl
• Phone: + 31 33 850 1716

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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.