Stress Urinary Incontinence
Conditions
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.
Interventions
OTHERiltamiocel
This is an observational study with no intervention.
Sponsors
Cook MyoSite
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long term safety | 5 years | Long term safety of iltamiocel |
| Long term effectiveness | 5 years | Long term effectiveness of iltamiocel |
Countries
United States
Contacts
STUDY_DIRECTORRon Jankowski, PhD
Cook MyoSite, Inc.
Outcome results
None listed