Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Lateral Suspension (LatGYNious)

What this Trial Is About

Researchers are evaluating the safety and performance of LatGYNious, an investigational pelvic floor mesh implant designed to improve pelvic organ prolapse in women. This study focuses on women with symptomatic prolapse in one of the three compartments at grade 2 or higher, with or without uterus, who are candidates for surgical treatment. The study aims to generate clinical data to assess this device's effectiveness and safety when used in laparoscopic lateral suspension surgery. LatGYNious combines two types of polypropylene mesh materials: an ultra-light, elastic mesh body with a wide hexagonal pore structure and a reinforced mesh with smaller pores for strong fixation at the mesh arms. For women opting to preserve their uterus, the posterior part of the mesh body may be removed. Participants will undergo laparoscopic lateral suspension using this mesh implant, either with uterus preservation or after hysterectomy. Participants will be monitored through follow-up visits at 6 and 12 months after surgery. Researchers will assess objective success, quality of life, subjective success, and any complications arising from the operation during these follow-ups. Participants must be willing and able to cooperate with follow-up examinations and provide informed consent. The total duration of participation lasts at least 12 months post-surgery to allow for thorough evaluation of outcomes and safety.

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