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

Pelvic Organ Prolapse Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05042453
Study type Observational
Source Promedon
Contact Philipp Schelhorn
Phone 00498031900400
Email trials.de@promedon.com
Status Recruiting
Phase
Start date December 19, 2022
Completion date December 1, 2028
View Details
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