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

N/ANot Yet RecruitingNCT07497321

A.M.I. Agency for Medical Innovations GmbH100 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Pelvic Organ Prolapse (POP)Synthetic Mesh Laparoscopic Surgery

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (5)

Universitätsklinikum Wiener Neustadt, Klinik für Gynäkologie und Geburtshilfe

Wiener Neustadt, Lower Austria, Austria

Kardinal Schwarzenberg Klinikum

Schwarzach im Pongau, State of Salzburg, Austria

Universitätsklinikum Erlangen, Frauenklinik

Erlangen, Bavaria, Germany

Klinik Agatharied, Gynäkologie & Geburtshilfe

Hausham, Bavaria, Germany

Universitätsmedizin Frankfurt, Klinik für Gynäkologie und Geburtshilfe

Frankfurt am Main, Hesse, Germany

Outcomes

Primary Outcomes

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