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

Cook Group

Status: Invitation-only

Conditions: Stress Urinary Incontinence

Treatments: Other: iltamiocel

Study type: Observational

Funder types: Industry

Identifiers

NCT06743620

R15-06

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

96 participants in 1 patient group

Patients with persistent or recurrent SUI following surgical treatment who have received iltamiocel

Treatment:

Other: iltamiocel