About this trial
This prospective study aims to assess the efficacy of the OviTex 1S permanent mesh in pelvic floor surgery in comparison with the current standard polypropylene mesh.
Eligibility criteria
Qualifiers
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;
Disqualifiers
Mentally incompetent patients (unable to fulfil questionnaires).
Allergy to ovine rumen.
A medical history of pelvic radiation therapy.
Scheduled for a redo-rectopexy.
Trial design
Treatments tested in this trial
- Minimal invasive abdominal prolapse surgery using Polypropylene mesh
- Minimal invasive abdominal prolapse surgery using OviTex 1S permanent mesh
Treatment groups
Sponsors and collaborators
Meander Medical Center
Lead sponsor
Health Holland
Collaborator