Tettnang

This research aims to assess the long-term effectiveness and safety of hysteropexy using the Splentis device via the vaginal route to treat primary uterine prolapse in women. The study focuses on women with primary apical pelvic organ prolapse and monitors multiple outcomes over an extended period. The goal is to evaluate anatomical correction, subjective improvement, and the need for retreatment, along with detailed safety data. Participants will receive anterior cervicopexy with bilateral sacrospinous ligament fixation using the Splentis POP Tissue Anchoring System. This is a single-arm trial conducted across multiple centers, with follow-up extending up to 60 months. The treatment involves a specialized surgical procedure designed to correct uterine prolapse by anchoring pelvic tissues. During the study, women will attend regular visits for up to five years to assess treatment success, including anatomical measures and patient-reported outcomes such as bladder symptoms, urinary incontinence, quality of life, and sexual function. Researchers will carefully document any adverse events and monitor the cure of apical pelvic organ prolapse at 12 months as a primary outcome measure. This comprehensive follow-up helps ensure long-term safety and effectiveness information is collected.

Researchers are evaluating the safety and effectiveness of the LatGYNious, a specially designed pelvic floor mesh implant, for treating pelvic organ prolapse in women. This condition involves the descent of pelvic organs, and the study aims to generate clinical data to support the use of this device in surgical treatment. The trial focuses on female participants with symptomatic prolapse of grade 2 or higher in one of the pelvic compartments, with or without the uterus. The LatGYNious device combines two types of polypropylene mesh materials to provide both elasticity and strong lateral fixation. The mesh is implanted using a laparoscopic lateral suspension technique, either preserving the uterus or following a hysterectomy. In cases where the uterus is preserved, part of the mesh is removed to accommodate. The study assesses the performance and safety of this device during and after surgery. Participants will be followed up for 6 and 12 months after surgery to measure the success of the treatment. Researchers will monitor pelvic organ prolapse symptoms and any adverse effects related to the mesh implant. The study requires participants to attend follow-up examinations and provide informed consent to participate and share their health information for research purposes.