Long-term Evaluation of the I-STOP Sling in Stress Urinary Incontinence Treatment
NCT ID: NCT06665698
Last Updated: 2024-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
500 participants
OBSERVATIONAL
2024-11-30
2034-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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DILO Medical
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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VI-IS-24
Identifier Type: -
Identifier Source: org_study_id
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