NCT05042453

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

Prospective, Multicenter, 60 Months, Single-arm Cohort Trial for Evaluation of the Efficacy and Safety of Transvaginal Sacrospinous Ligament Fixation With Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: Promedon · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, multi center cohort trial aims to evaluate the efficacy and safety of hysteropexy using Splentis via the vaginal route in primary uterine prolapse

Detailed description

Women who undergo hysteropexy with Splentis via the vaginal route for primary uterine prolapse will be evaluated regarding efficacy and safety in a long term follow-up of 60 months. The primary endpoint is composed of anatomical, subjective and re-treatment components, whereas several secondary endpoints focusing on functional outcome including overactive bladder symptoms, urinary incontinence, quality of life and sexual life will be considered. Furthermore, a detailed report about adverse events will be included.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
DEVICE	Splentis® POP Tissue Anchoring System	Anterior cervicopexy with bilateral sacrospinous ligament fixation using Splentis

Timeline

• Start date: 2022-12-19
• Primary completion: 2026-07-01
• Completion: 2030-07-01
• First posted: 2021-09-13
• Last updated: 2024-11-22

Locations

7 sites across 1 country: Germany