Tettnang

This research aims to assess the long-term effectiveness and safety of hysteropexy using the Splentis device through the vaginal route in women with primary uterine prolapse. The study focuses on women who have non-fertile status and primary symptomatic uterine descent, addressing important outcomes like anatomical correction, symptoms, and the need for further treatments. It is a prospective, multicenter observational study with a follow-up lasting 60 months to understand sustained outcomes. Participants will receive hysteropexy with the Splentis device, which involves anterior cervicopexy combined with bilateral sacrospinous ligament fixation via the vaginal approach. This single-arm study includes women scheduled for this procedure independent of the trial. The interventions safety and efficacy will be observed over a 5-year period, capturing data at multiple timepoints to monitor progress and any complications. During the study, participants will undergo evaluations at baseline, 6 weeks, and at 12, 24, 36, and 60 months post-procedure. These assessments include measures of prolapse cure, quality of life, urinary incontinence, overactive bladder symptoms, sexual function, pain, and patient-reported improvement. Researchers will also document adverse events and device-related complications. The trial offers comprehensive long-term monitoring to better understand outcomes and safety for women undergoing this treatment.

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.