Evaluating Safety and Performance of LatGYNious Pelvic Floor Mesh Implant for Treatment of Female Pelvic Organ Prolapse

What this Trial Is About

Researchers are evaluating the safety and performance of LatGYNious, a specially designed pelvic floor mesh implant, for treating female pelvic organ prolapse. This condition involves the descent of pelvic organs, and the study focuses on women with symptomatic prolapse who are candidates for surgical treatment. The goal is to gather clinical data to understand how well this device works and its safety profile. LatGYNious combines two types of polypropylene meshes an ultra-light monofilament mesh with a wide hexagonal pore structure for elasticity, and a reinforced mesh with a smaller pore size for strong fixation. The implant is used in laparoscopic lateral suspension surgery, either preserving the uterus or after hysterectomy. If the uterus is preserved, part of the mesh is removed. Participants will receive this mesh implant during their surgical procedure. Participants will be involved in follow-up assessments up to 12 months after surgery to measure objective success, subjective success, quality of life, and any complications from the operation. They are expected to cooperate with these follow-ups to help researchers evaluate the treatment outcomes and safety over time. The total study duration includes these monitoring periods after the surgery.

Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)