Long-term Study of Splentis Device for Treating Primary Uterine Prolapse through Vaginal Surgery

What this Trial Is About

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.

Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse