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NCT Number: NCT07497321

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

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Key information

Conditions

Pelvic Organ Prolapse (POP) Gynecologic Laparoscopic Surgery Implant Laparoscopic Surgery Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Floor Pelvic Floor Prolapse Pelvic Organ Prolapse Prolapse Sacrocolpopexy Synthetic Mesh

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Wiener Neustadt, Klinik für Gynäkologie und Geburtshilfe, Wiener Neustadt, Lower Austria, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Surgical mesh for pelvic organ prolapse repair (ProGYNious)

Device

Implantation of a pelvic floor mesh implant for laparoscopic sacrocolpopexy

Primary outcomes

  1. Objective cure rate for pelvic organ prolapse

    Time frame: 3 months and 12 months post-operative

    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

Secondary outcomes

  1. Complications and adverse events during follow-up

    Time frame: 3 months and 12 months post-operative

    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

  2. Objective outcome (POP-Q)

    Time frame: 3 months and 12 months post-operative

    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. Quality of Life (QoL) and sexual function

    Time frame: 3 months and 12 months post-operative

    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.

  4. Subjective success

    Time frame: 3 months and 12 months post-operative

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Florian Blab, MA

CONTACT

[email protected]

+43 5522 90505-0

Sponsors and collaborators

Lead sponsor

A.M.I. Agency for Medical Innovations GmbH

Industry

Registry information

Acronym: ProGYNious

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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