Pelvic floor mesh used in laparoscopic sacrocolpopexy to repair pelvic organ prolapse

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 is a prospective international post-market clinical investigation evaluating the ProGYNious Y-shaped mesh for sacrocolpopexy in pelvic organ prolapse. It collects data on treatment outcomes, safety, complications, and quality of life, with follow-up examinations to monitor durability. The mesh combines two polypropylene materials with different pore structures to optimize fixation and elasticity. Multiple centers participate to assess performance in real-world surgical settings. Eligible participants are adults with symptomatic prolapse indicated for ProGYNious repair and who consent to follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subject is a candidate for surgical repair of pelvic organ prolapse by ProGYNious implant according to the indication of the product under evaluation
* Symptomatic pelvic organ prolapse with POP-Q \>= 2
* Age \>18 years and ≤ 80years
* Subject is willing and able to cooperate with follow-up examinations
* Subject has been informed of the study procedures and the treatment and has signed an informed consent form

Exclusion Criteria:

* previous or concurrent cancer which may affect the successful treament with laparoscopic mesh
* known or suspected hypersensitivity to ProGYNious mesh or a component of ProGYNious mesh (Polypropylene)
* known severe osteoporosis
* pregnancy, suspected pregnancy and breastfeeding
* bleeding of unknown cause in the genital area
* previously irradiated patients in the pelvic area
* drug or medication abuse, medical, psychological or social circumstances that could affect the patient's participation in the study or the evaluation of the study results
* Any previous interventions with surgical mesh for pelvic organ prolapse and/or urinary incontinence
* Unable to understand study requirements or is unable to comply with follow-up schedule
* Contraindicated according to the instruction for use of the device
* patients with an increased risk of infection or impaired wound healing (e.g. Diabetes mellitus with HbA1c \>10, systemic autoimmune diseases, etc.)
* concomitant Sling/TVT procedure
* life expectancy lower than follow-up period (e.g. ASA 4)
* non-symptomatic pelvic organ prolapse
* chronic pain syndrome
* chronic respiratory disease (e.g. COPD, chronic cough)

Where it's running

• Universitätsklinikum Wiener Neustadt, Klinik für Gynäkologie und Geburtshilfe
  Wiener Neustadt, Lower Austria, Austria Recruiting
• Universitätsklinikum Erlangen, Frauenklinik
  Erlangen, Bavaria, Germany Not yet recruiting
• Klinik Agatharied, Gynäkologie & Geburtshilfe
  Hausham, Bavaria, Germany Not yet recruiting
• Universitätsmedizin Frankfurt, Klinik für Gynäkologie und Geburtshilfe
  Frankfurt am Main, Hesse, Germany Not yet recruiting

Study contacts

• Principal investigator: Balazs Stenczer, MD — University Hospital Wiener Neustadt
• Study coordinator: Florian Blab, MA
• Email: ca@ami.at
• Phone: +43 5522 90505-0

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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.