Gynecologic Laparoscopic Surgery, Implant, Laparoscopic Surgery, Pelvic Floor, Pelvic Floor Prolapse, Pelvic Organ Prolapse (POP), Sacrocolpopexy, Synthetic Mesh
Conditions
Keywords
ProGYNious, A.M.I., AMI, Agency for Medical Innovation, Y Mesh, Progyn
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.
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.
Interventions
DEVICESurgical mesh for pelvic organ prolapse repair (ProGYNious)
Implantation of a pelvic floor mesh implant for laparoscopic sacrocolpopexy
Sponsors
A.M.I. Agency for Medical Innovations GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective cure rate for pelvic organ prolapse | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications and adverse events during follow-up | 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 |
| Objective outcome (POP-Q) | 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. |
| Quality of Life (QoL) and sexual function | 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. |
| Subjective success | 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 |
Countries
Austria, Germany
Contacts
CONTACTFlorian Blab, MA
PRINCIPAL_INVESTIGATORBalazs Stenczer, MD
University Hospital Wiener Neustadt
Outcome results
None listed