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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-11

Study Completion Date

2032-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence

NCT03104517

Stress Urinary Incontinence

ACTIVE_NOT_RECRUITING PHASE3

Autologous Muscle Derived Cells for Female Urinary Sphincter Repair

NCT01893138

Stress Urinary Incontinence

COMPLETED PHASE3

Autologous Cell Therapy for Female Stress Urinary Incontinence

NCT01008943

Stress Urinary Incontinence

COMPLETED PHASE2

Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study

NCT01382602

Urinary Incontinence, Stress

COMPLETED PHASE3

Efficacy of Conservative Treatments for Urinary Incontinence in Women

NCT05977231

Urinary Incontinence

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stress Urinary Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

iltamiocel

Intervention Type OTHER

This is an observational study with no intervention.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

iltamiocel

This is an observational study with no intervention.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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