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

Part of paid clinical trials in Harvard, Massachusetts.

Sponsor
Cook MyoSite
Study ID
NCT06743620
Status
Enrolling By Invitation

Conditions

  • Stress Urinary Incontinence

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • iltamiocel — OTHER
    This is an observational study with no intervention.

Study Details

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 Dates

Start date
Apr 11, 2025
Status verified
Apr 2025
Primary completion
Apr 30, 2032
Completion
Apr 30, 2032

Study Design

Enrollment
96 participants (estimated)

Arms

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

Primary Outcome Measure

Long term safety [ Time Frame: 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Virtual SiteHarvardMassachusetts01451-

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By research site
Virtual Site· Harvard, MA

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