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

Enrolling by invitation

Conditions studied: Stress Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT06743620

Run by

Cook MyoSite

People needed

96

Starts

2025-04-11

Expected to finish

2032-04-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Virtual Site — Harvard, Massachusetts, United States

Full record on ClinicalTrials.gov

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