Long-term Evaluation of the I-STOP Sling in Stress Urinary Incontinence Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Stress Urinary Incontinence (SUI). Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Study to the Evaluate the Long-term Use of Synthetic I-STOP® Device for Treatment of Stress Urinary Incontinence in Women
Overview
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.
Primary outcome measures
- Rate of reintervention [Time frame: One year after surgery and after each year during 10 years]
Secondary outcome measures (1)
- Quality of Life [Time frame: One year after surgery and after each year during 10 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06665698 · VI-IS-24