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

NCT06743620 | Enrolling By Invitation FDA Drug

• 1 other identifier: R15-06
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• Long term safety

  Long term safety of iltamiocel

  5 years

• Long term effectiveness

  Long term effectiveness of iltamiocel

  5 years

Study Arms (1)

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

Other: iltamiocel

Interventions

iltamiocel OTHER

This is an observational study with no intervention.

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female subjects who have received iltamiocel as part of participation in the CLBT clinical study for females with persistent or recurrent SUI following surgical treatment will be considered for enrollment.

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.

Sponsors & Collaborators

• Cook MyoSite: lead

Study Sites (1)

Virtual Site

Harvard, Massachusetts, 01451, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ron Jankowski, PhD

  Cook MyoSite, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: April 11, 2025
• Primary Completion (Estimated): April 1, 2032
• Study Completion (Estimated): April 1, 2032
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)