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Long-term Evaluation of the I-STOP Sling in Stress Urinary Incontinence Treatment | Clinical Trials | Clareo Health

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

Prospective Study to the Evaluate the Long-term Use of Synthetic I-STOP® Device for Treatment of Stress Urinary Incontinence in Women

NCT06665698•DILO Medical

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

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.

Key Dates

Start Date

November 1, 2024

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2034

Last Updated

October 30, 2024

Enrollment

500

ESTIMATED participants

Conditions

Stress Urinary Incontinence (SUI)

Contacts

Vincent Goria

CONTACT

+33478425845 contact@dilomedical.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence

Elastographic Assessment of Suburethral Tissue in Continent and Incontinent Women

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Long-term Outcomes of Urethral Ligament Plication and Transvaginal Tape Surgery

A Clinical Study of the Effectiveness and Safety of a Disposable Intra-vaginal Device for Stress Urinary Incontinence (SUI)