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Not yet recruiting NCT07497321

Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)

No phase Interventional Pelvic Organ Prolapse (POP) Synthetic Mesh Laparoscopic Surgery Gynecologic Laparoscopic Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surgical mesh for pelvic organ prolapse repair (ProGYNious).
Who it may be relevant to
Registry conditions: Pelvic Organ Prolapse (POP), Synthetic Mesh, Laparoscopic Surgery, Gynecologic Laparoscopic Surgery. Basic parameters: 18 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria, Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The purpose of this clinical investigation is to collect clinical data about the ProGYNious Mesh based on a prospective clinical investigation. The primary objective is to verify the treatment outcome and success of the ProGYNious mesh implant in pelvic organ prolapse repair. The secondary objective is to confirm the safety, risks, complications and quality of life of ProGYNious as an implant for pelvic organ prolapse repair.

Detailed description

ProGYNious is a Y-shaped synthetic mesh implant which combines two types of polypropylene meshes with different properties. The mesh body is made of ultra-light monofilament polypropylene with a wide hexagonal pore structure with a high level of elasticity. A reinforced mesh material with a smaller pore structure is used for the mesh neck which achieves a strong fixation to the sacral promontory.

This study is a prospective international multi-center post-market clinical investigation with five participating medical centers.

Interventions

  • Device Surgical mesh for pelvic organ prolapse repair (ProGYNious)
    Implantation of a pelvic floor mesh implant for laparoscopic sacrocolpopexy

Primary outcome measures

  • Objective cure rate for pelvic organ prolapse [Time frame: 3 months and 12 months post-operative]
Secondary outcome measures (4)
  • Complications and adverse events during follow-up [Time frame: 3 months and 12 months post-operative]
  • Objective outcome (POP-Q) [Time frame: 3 months and 12 months post-operative]
  • Quality of Life (QoL) and sexual function [Time frame: 3 months and 12 months post-operative]
  • Subjective success [Time frame: 3 months and 12 months post-operative]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 3 centers
  • Universitätsklinikum Erlangen, Frauenklinik — Erlangen
  • Klinik Agatharied, Gynäkologie & Geburtshilfe — Hausham
  • Universitätsmedizin Frankfurt, Klinik für Gynäkologie und Geburtshilfe — Frankfurt am Main
Austria · 2 centers
  • Universitätsklinikum Wiener Neustadt, Klinik für Gynäkologie und Geburtshilfe — Wiener Neustadt
  • Kardinal Schwarzenberg Klinikum — Schwarzach im Pongau

Identifiers

NCT: NCT07497321 · PMCF-51-005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗