← Back to all trials
Enrolling By Invitation
NCT06743620
Observational Registry for Iltamiocel Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
Conditions: Stress Urinary Incontinence
Sex: Female
Ages: 18 Years – 100 Years
Healthy volunteers: No
Enrollment: 96
Sponsor: Cook MyoSite
Location: Virtual Site Harvard Massachusetts
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.
Eligibility Criteria
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
Exclusion Criteria:
* Has only received placebo as part of the CLBT study.
* Unable or unwilling to provide informed consent.
Source: ClinicalTrials.gov (NCT06743620). StuddyBuddy aggregates publicly available trial information.