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Enrolling by invitationNCT06743620CLBT RGSTUpdated Jul 22, 2026

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

An observational study in Stress Urinary Incontinence, sponsored by Cook MyoSite. Enrolling by invitation at 1 site in United States. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by Cook MyoSite · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
96
Ages
18 Years to 100 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Stress Urinary Incontinence
03

In context

Urinary Incontinence, Stress

658 studies on the registry are indexed under Urinary Incontinence, Stress; 123 are open to participants now.

This study's planned enrollment of 96 is below the median of 139 across 130 observational studies indexed under Urinary Incontinence, Stress.

Browse Urinary Incontinence, Stress studies →

Lead sponsor

Cook MyoSite is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Has only received placebo as part of the CLBT study.
  • Unable or unwilling to provide informed consent.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
96 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

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

    Other: iltamiocel

Interventions

  • Otheriltamiocel

    This is an observational study with no intervention.

06

What researchers measure

Primary outcomes

  1. Long term safety

    Long term safety of iltamiocel

    Time frame: 5 years

  2. Long term effectiveness

    Long term effectiveness of iltamiocel

    Time frame: 5 years

07

Study locations

1 site
  • Virtual Site
    Harvard, Massachusetts 01451, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06743620
Lead sponsor
Cook MyoSite
Responsible party
Sponsor
First posted
Dec 20, 2024
Start date
Apr 11, 2025
Primary completion
Apr 2032 (estimated)
Completion
Apr 2032 (estimated)
Last update
Jul 22, 2026

Study contacts

Ron Jankowski, PhD
study director · Cook MyoSite, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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