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

NCT06665698 | Not Yet Recruiting

• 1 other identifier: VI-IS-24
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Stress Urinary Incontinence (SUI)

Keywords

I-STOP; MUS; Sling

Outcome Measures

Primary Outcomes (1)

• Rate of reintervention

  Questionnaire sent every year to the patient with question about revision surgery: yes / no

  One year after surgery and after each year during 10 years

Secondary Outcomes (1)

• Quality of Life

  One year after surgery and after each year during 10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population is made up of patients with SUI who should benefit from the implantation of an I-STOP® implant in one of the centers associated with the project.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DILO Medical: lead

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Vincent Goria

CONTACT

+33478425845; contact@dilomedical.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 30, 2024
• Study Start: November 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2034
• Last Updated: October 30, 2024

Record last verified: 2024-10