Observational Registry for Iltamiocel Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence

Not yet recruiting

• Conditions: Stress Urinary Incontinence

• Registration Number: NCT06743620
• Lead Sponsor: Cook MyoSite

Brief Summary

The main purpose of this registry is to collect observational, long-term safety and effectiveness data in subjects who have received at least one dose of iltamiocel as part of the CLBT clinical study.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Study Start: 2025-01
• Primary Completion: 2032-04
• Study Completion: 2032-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

• Has completed participation within 15 months in the CLBT clinical study for females with persistent or recurrent SUI following surgical treatment (i.e., either subject has completed all follow-up visits or has been officially exited from the study).
• Has received at least one dose of iltamiocel as part of the CLBT study.
• Must be willing and able to comply with the study procedures, is able to understand all study requirements and must agree to read and sign the informed consent form prior to any study-related procedures.
• Has access to a phone or electronic device to allow completion of electronic documents

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Exclusion Criteria

• Has only received placebo as part of the CLBT study.
• Unable or unwilling to provide informed consent.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long term safety	5 years	Long term safety of iltamiocel
Long term effectiveness	5 years	Long term effectiveness of iltamiocel