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 4 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
- 4 sitesin 2 countries
- Study dates
- 28 Oct 2026to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Show all 16Show fewer
- 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
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Germany3 sites, 3 recruiting
- Not yet recruiting
Universitätsklinikum Erlangen, Frauenklinik
Erlangen, Bavaria, 91054
Felix Heindl, MD, PD MHBA
Felix Heindl, MD, MHBA
- Not yet recruiting
Universitätsmedizin Frankfurt, Klinik für Gynäkologie und Geburtshilfe
Frankfurt am Main, Hesse, 60596
Khayal Gasimli, MD, Prof.
Khayal Gasimli, MD, Prof.
- Not yet recruiting
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.
Austria1 site, 1 recruiting
- Recruiting
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 start28 Oct 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2029 (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
- Oct 2026
- First submitted
- 18 Mar 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
- ClinicalTrials.gov ID
- NCT07497321
- Acronym / sponsor ID
- ProGYNious / PMCF-51-005
- Conditions
- Pelvic Organ Prolapse (POP), Synthetic Mesh, Laparoscopic Surgery, Gynecologic Laparoscopic Surgery, Sacrocolpopexy, Pelvic Floor Prolapse
- Keywords
- ProGYNious, A.M.I., AMI, Agency for Medical Innovation, Y Mesh, Progyn
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- A.M.I. Agency for Medical Innovations GmbHIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic surgery with a synthetic mesh implant (ProGYNious) | Experimental | Device: Surgical mesh for pelvic organ prolapse repair (ProGYNious)Implantation of ProGYNious |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical mesh for pelvic organ prolapse repair (ProGYNious)Implantation of a pelvic floor mesh implant for laparoscopic sacrocolpopexy | Device | Laparoscopic surgery with a synthetic mesh implant (ProGYNious) |
Primary outcome
Objective cure rate for pelvic organ prolapse
Time frame: 3 months and 12 months post-operative
Objective cure rate during follow-up defined by: 1. Anatomic cure by POP-Q <= 1 (Pelvic Organ Prolapse Quantification System) 2. Absence of bulge symptoms 3. No additional pelvic organ prolapse treatment necessary
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Balazs Stenczer, MD principal investigator
University Hospital Wiener Neustadt
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florian Blab, MA (+43 5522 90505-0, ca@ami.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective cure rate for pelvic organ prolapse (time frame: 3 months and 12 months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.