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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Laparoscopic Surgery; Implant; Pelvic Floor; Pelvic Floor Prolapse; Gynecologic Laparoscopic Surgery; Synthetic Mesh; Pelvic Organ Prolapse (POP); Sacrocolpopexy
• Intervention / Treatment: Device: Surgical mesh for pelvic organ prolapse repair (ProGYNious)

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florian Blab, MA; Phone Number: +43 5522 90505-0; Email: ca@ami.at

Study Locations

• Austria
  • Lower Austria
    • Wiener Neustadt, Lower Austria, Austria, 2700
      • Universitätsklinikum Wiener Neustadt, Klinik für Gynäkologie und Geburtshilfe
      • Contact: Balázs Stenczer, MD
      • Principal Investigator: Balázs Stenczer, MD
      • Sub-Investigator: Balint Balogh, MD, MHBA
  • Salzburg
    • Schwarzach im Pongau, Salzburg, Austria, 5620
      • Kardinal Schwarzenberg Klinikum
      • Contact: Norbert Maczó, MD
      • Principal Investigator: Norbert Maczó, MD
      • Sub-Investigator: Rebecca Zach, MD
• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Universitätsklinikum Erlangen, Frauenklinik
      • Contact: Felix Heindl, MD, PD MHBA
      • Principal Investigator: Felix Heindl, MD, MHBA
      • Sub-Investigator: Stephanie Burghaus, MD, MHBA
    • Hausham, Bavaria, Germany, 83734
      • Klinik Agatharied, Gynäkologie & Geburtshilfe
      • Contact: Stefan Rimbach, MD, PD Dr. med. Dr. h. c.
      • Principal Investigator: Stefan Rimbach, MD, PD Dr. med. Dr. h. c.
      • Sub-Investigator: Miriam Schempershofe, MD
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60596
      • Universitätsmedizin Frankfurt, Klinik für Gynäkologie und Geburtshilfe
      • Contact: Khayal Gasimli, MD, Prof.
      • Principal Investigator: Khayal Gasimli, MD, Prof.
      • Sub-Investigator: Sven Becker, MD, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laparoscopic surgery with a synthetic mesh implant (ProGYNious); Implantation of ProGYNious	Device: Surgical mesh for pelvic organ prolapse repair (ProGYNious); Implantation of a pelvic floor mesh implant for laparoscopic sacrocolpopexy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective cure rate for pelvic organ prolapse	Objective cure rate during follow-up defined by: Anatomic cure by POP-Q <= 1 (Pelvic Organ Prolapse Quantification System); Absence of bulge symptoms; No additional pelvic organ prolapse treatment necessary	3 months and 12 months post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications and adverse events during follow-up	Peri- and post-operative complications, mesh erosion / mesh extrusion (analyzed according to the ICS/IUGA Complication Classification), de novo stress urinary incontinence, de novo urge urinary incontinence	3 months and 12 months post-operative
Objective outcome (POP-Q)	Intra-individual comparison of the POP-Q (Pelvic Organ Prolapse Quantification System) locations and antomical markers (pre-operative vs. post-operative). The Pelvic Organ Prolapse Quantification (POP-Q) system is an objective, standardized, site-specific system used by clinicians to assess, describe, and stage pelvic support in women. It uses 6 anatomical points measured in centimeters relative to the hymen to diagnose the severity of prolapse.	3 months and 12 months post-operative
Quality of Life (QoL) and sexual function	Analysis of the improvement in quality of life (QoL) and sexual function with the German Pelvic Floor Questionnaire (GPFQ, Deutscher Beckenbodenfragebogen). The GPFQ does contain the domains bladder function, bowel function, prolapse and sexual symptoms. In each domain a total of 10 points may be reached. The maximum symptom score for the entire questionnaire are 40 points.	3 months and 12 months post-operative
Subjective success	Subjective success described by Patients Global Impression of Improvement (PGI-I). Patient Global Impression of Improvement (PGI-I) score four years after incontinence surgery. The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians: Very much better; Much better; A little better; No change; A little worse; Much worse; Very much worse	3 months and 12 months post-operative

Collaborators and Investigators

• Sponsor: A.M.I. Agency for Medical Innovations GmbH
• Investigators: Principal Investigator: Balazs Stenczer, MD, University Hospital Wiener Neustadt

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: AMI; Y Mesh; ProGYNious; A.M.I.; Agency for Medical Innovation; Progyn
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pathological Conditions, Signs and Symptoms; Pelvic Organ Prolapse; Surgical Equipment; Equipment and Supplies; Surgical Mesh
• Other Study ID Numbers: PMCF-51-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No