Long-term Evaluation of the I-STOP Sling in Stress Urinary Incontinence Treatment

Not yet recruiting

• Conditions: Stress Urinary Incontinence (SUI)

• Registration Number: NCT06665698
• Lead Sponsor: DILO Medical

Brief Summary

Evaluate quality of life and rate of reoperation after implantation of the I-STOP sling for stress urinary incontinence

Detailed Description

This is a prospective, multicenter, non-comparative, interventional post-marketing clinical follow-up study (PMCF) on a population of patients with SUI requiring surgical treatment with implantation of an I-STOP sling to document safety, the performance and effectiveness in the short, medium, and long term of these I-STOP® implants used in their intended purpose.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-28
• Last Update Submitted: 2024-10-28
• Study First Posted: 2024-10-30
• Last Update Posted: 2024-10-30
• Study Start: 2024-11
• Primary Completion: 2025-12
• Study Completion: 2034-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• Adult woman aged over 18 ;
• Patient with SUI, having escaped "conservative" medical treatment, with indication for surgical treatment with implantation of an I-STOP® strip via trans-obturator or retropubic route as indicated in the instructions for use of the SUI implant ;
• Patient affiliated to a social security scheme;
• Patient capable of completing a self-questionnaire;
• Patient able to understand the protocol and follow the visit schedule;
• Patient having signed informed consent.

Exclusion Criteria

• Minor patient, pregnant or breastfeeding ;
• Adult patient subject to a measure of legal protection, guardianship, curatorship or deprived of liberty by judicial or administrative decision ;
• Patient presenting a contraindication to the use of the implant indicated in the instructions for use of the implant ;
• Patient with a medical contraindication to surgery and/or anaesthesia.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of reintervention	One year after surgery and after each year during 10 years	Questionnaire sent every year to the patient with question about revision surgery: yes / no

Secondary Outcome Measures

Name	Time	Method
Quality of Life	One year after surgery and after each year during 10 years	Questionnaire sent every year: Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7)