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.
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
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
Single group
Surgical mesh for pelvic organ prolapse repair (ProGYNious)
DeviceImplantation of a pelvic floor mesh implant for laparoscopic sacrocolpopexy
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
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
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.
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.
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
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