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

NCT07497321 | Not Yet Recruiting DMC

• 1 other identifier: PMCF-51-005
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 5

Brief 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. The secondary objective is to confirm the safety, risks, complications and quality of life of ProGYNious as an implant for pelvic organ prolapse repair.

Conditions

Pelvic Organ Prolapse (POP); Synthetic Mesh; Laparoscopic Surgery; Gynecologic Laparoscopic Surgery; Sacrocolpopexy; Pelvic Floor Prolapse; Pelvic Floor; Implant

Keywords

ProGYNious; A.M.I.; AMI; Agency for Medical Innovation; Y Mesh; Progyn

Outcome Measures

Primary Outcomes (1)

• Objective cure rate for pelvic organ prolapse

  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

  3 months and 12 months post-operative

Secondary Outcomes (4)

• Complications and adverse events during follow-up

  3 months and 12 months post-operative

• Objective outcome (POP-Q)

  3 months and 12 months post-operative

• Quality of Life (QoL) and sexual function

  3 months and 12 months post-operative

• Subjective success

  3 months and 12 months post-operative

Study Arms (1)

Laparoscopic surgery with a synthetic mesh implant (ProGYNious)

EXPERIMENTAL

Implantation of ProGYNious

Device: Surgical mesh for pelvic organ prolapse repair (ProGYNious)

Interventions

Surgical mesh for pelvic organ prolapse repair (ProGYNious) DEVICE

Implantation of a pelvic floor mesh implant for laparoscopic sacrocolpopexy

Laparoscopic surgery with a synthetic mesh implant (ProGYNious)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• A.M.I. Agency for Medical Innovations GmbH: lead

Study Sites (5)

Universitätsklinikum Wiener Neustadt, Klinik für Gynäkologie und Geburtshilfe

Wiener Neustadt, Lower Austria, 2700, Austria

Location

Kardinal Schwarzenberg Klinikum

Schwarzach im Pongau, Salzburg, 5620, Austria

Location

Universitätsklinikum Erlangen, Frauenklinik

Erlangen, Bavaria, 91054, Germany

Location

Klinik Agatharied, Gynäkologie & Geburtshilfe

Hausham, Bavaria, 83734, Germany

Location

Universitätsmedizin Frankfurt, Klinik für Gynäkologie und Geburtshilfe

Frankfurt am Main, Hesse, 60596, Germany

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Surgical Mesh

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Balazs Stenczer, MD

  University Hospital Wiener Neustadt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian Blab, MA

CONTACT

+43 5522 90505-0; ca@ami.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 27, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); AU (2)