Long-term Evaluation of the I-STOP Sling in Stress Urinary Incontinence Treatment (VIGI-ISTOP)

DILO Medical

Status: Not yet enrolling

Conditions: Stress Urinary Incontinence (SUI)

Study type: Observational

Funder types: Industry

Identifiers

NCT06665698

VI-IS-24

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.