Pelvic Organ Prolapse (POP)ProGYNiousNCT07497321
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
A study testing Surgical mesh for pelvic organ prolapse repair (ProGYNious) in people with Pelvic Organ Prolapse (POP) and Synthetic Mesh, run by A.M.I. Agency for Medical Innovations GmbH at 5 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse (POP), Synthetic Mesh, Laparoscopic Surgery
- What is being tested?
- Surgical mesh for pelvic organ prolapse repair (ProGYNious)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 15 Apr 2026to 30 Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Germany3 sites
Universitätsklinikum Erlangen, Frauenklinik
Erlangen, Bavaria, 91054
Felix Heindl, MD, PD MHBA
Felix Heindl, MD, MHBA
Universitätsmedizin Frankfurt, Klinik für Gynäkologie und Geburtshilfe
Frankfurt am Main, Hesse, 60596
Khayal Gasimli, MD, Prof.
Khayal Gasimli, MD, Prof.
Klinik Agatharied, Gynäkologie & Geburtshilfe
Hausham, Bavaria, 83734
Stefan Rimbach, MD, PD Dr. med. Dr. h. c.
Stefan Rimbach, MD, PD Dr. med. Dr. h. c.
Austria2 sites
Kardinal Schwarzenberg Klinikum
Schwarzach im Pongau, State of Salzburg, 5620
Norbert Maczó, MD
Norbert Maczó, MD
Universitätsklinikum Wiener Neustadt, Klinik für Gynäkologie und Geburtshilfe
Wiener Neustadt, Lower Austria, 2700
Balázs Stenczer, MD
Balázs Stenczer, MD
About this study
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.
Read the 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.
- Conditions
- Pelvic Organ Prolapse (POP), Synthetic Mesh, Laparoscopic Surgery, Gynecologic Laparoscopic Surgery, Sacrocolpopexy, Pelvic Floor Prolapse
- Being tested
- Surgical mesh for pelvic organ prolapse repair (ProGYNious)
- Keywords
- ProGYNious, A.M.I., AMI, Agency for Medical Innovation, Y Mesh, Progyn
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical mesh for pelvic organ prolapse repair (ProGYNious)Device
Implantation of a pelvic floor mesh implant for laparoscopic sacrocolpopexy
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic surgery with a synthetic mesh implant (ProGYNious) | Experimental | Implantation of ProGYNious Receives: Device: Surgical mesh for pelvic organ prolapse repair (ProGYNious) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months and 12 months post-operative
Secondary outcomes (4)
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3 months and 12 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ Prolapse (POP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.M.I. Agency for Medical Innovations GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Balazs Stenczer, MD, Principal investigator, University Hospital Wiener Neustadt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497321
- Sponsor's protocol ID
- PMCF-51-005
- Acronym
- ProGYNious
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No