LatGYNious pelvic mesh for treating 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

The device is a preformed pelvic mesh that combines an ultra-light, elastic polypropylene body with reinforced mesh arms designed for strong lateral fixation. Patients with symptomatic pelvic organ prolapse grade 2 or higher who are candidates for surgical repair will receive laparoscopic lateral suspension using the LatGYNious implant, with the mesh posterior portion removed if uterus preservation is planned. The study will collect clinical data on safety outcomes and anatomical and functional performance over scheduled follow-up visits. The goal is to characterize complication rates, fixation strength, and prolapse recurrence after implantation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Symptomatic prolapse in one of the 3 compartments from grade 2 with or without uterus
* Subject is candidate for a surgical treatment of pelvic organ prolapse
* 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 and provided authorization to use and disclose information for research purposes.

Exclusion Criteria:

* Previous surgical treatment with a mesh implant for pelvic organ prolapse (mesh implant in anterior or posterior compartment)
* Active immunotherapy which may negatively affect the treatment with a surgical mesh
* Active cancer of the vagina / cervix / rectum
* . known or suspected hypersensitivity to Polypropylene
* Pregnancy
* participation in another study at the same time
* Unable to understand study requirements or is unable to comply with follow-up schedule
* Contraindicated according to the instruction for use of the device

Where it's running

• BZK St. Johann in Tirol
  Sankt Johann in Tirol, Tyrol, Austria Recruiting
• Universitätsklinikum Wiener Neustadt, Klinische Abteilung für Gynäkologie und Geburtshilfe
  Wiener Neustadt, Austria Recruiting
• Universitätsklinik Brandenburg a.d. Havel, Klinik für Frauenheilkunde und Geburtshilfe
  Brandenburg, Germany Not yet recruiting
• Krankenhaus St. Joseph-Stift Bremen
  Bremen, Germany Not yet recruiting
• Medizincampus Bodensee - Klinik Tettnang
  Tettnang, Germany Not yet recruiting

Study contacts

• Principal investigator: Tina Cadenbach-Blome, Dr. med. — Medizincampus Bodensee - Klinik Tettnang
• Study coordinator: Florian Blab
• Email: florian.blab@ami.at
• Phone: +43 5522 90505 4062

Similar studies

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

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

  This study tests the ProGYNious mesh to see if it safely and effectively repairs pelvic organ prolapse in adults undergoing laparoscopic surgery.

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  Recruiting Pusan National University Yangsan Hospital · Yangsan · NCT07620782

• Risk predictor for new urinary incontinence after prolapse surgery

  This study tests a model to predict which women might develop new stress urinary incontinence after pelvic organ prolapse repair.

  Recruiting Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Shanghai, Shanghai Municipality · NCT07601282

• Pre-incisional ropivacaine plus triamcinolone for pain after laparoscopic surgery

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• Superior hypogastric plexus block to improve recovery after laparoscopic colorectal cancer surgery

  This will test whether adding a superior hypogastric plexus block helps adults having laparoscopic colorectal cancer surgery recover faster and have less pain.

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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.