Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
- Conditions
- Stress Urinary Incontinence
- Interventions
- Biological: AMDC-USR (iltamiocel)Other: Placebo
- Registration Number
- NCT03104517
- Lead Sponsor
- Cook MyoSite
- Brief Summary
This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) compared to a placebo in the reduction of stress incontinence episode frequency in adult female patients with post-surgical persistent or recurrent stress urinary incontinence (SUI). Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive placebo.
- Detailed Description
Stress urinary incontinence (SUI) is the accidental loss of urine due to physical activity, such as laughing, coughing, or sneezing. Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) involves a medical procedure in which a participant's own muscle cells are collected, processed, and then injected into the tissues of the urinary passage.
This is a double-blind randomized study, which means neither the participant, nor the study doctor will know which treatment group the participant will be in. Participants who are randomly chosen to receive injection with placebo will have the option to receive an injection with their cells after completion of the blinded portion of their study participation (12 months).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 96
- Adult female patient ≥ 18 years of age who has primary and moderate-to-severe symptoms of SUI for at least 6 months, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation.
- History of previous surgery for treatment of SUI. Previous surgery could include midurethral sling, retropubic suspension, or bladder neck sling. Bulking agents alone are not considered previous surgery for treatment of SUI.
- Must be willing and able to comply with the study procedures, be mentally competent and able to understand all study requirements, and must agree to read and sign the informed consent form prior to any study-related procedures.
- Must have completed 100% of the screening 3-day diary evening reports.
- Patient has symptoms of only urge incontinence as confirmed by basic evaluation of etiology from a patient medical history, including a focused incontinence history.
- Patient has symptoms of mixed urinary incontinence where urge incontinence is the predominant factor.
- Patient has had stress urinary incontinence symptoms less than 6 months prior to signing the informed consent.
- Patient has not previously attempted conservative treatment prior to signing the informed consent. (Examples of conservative treatment include behavior modifications, bladder exercises, biofeedback, pelvic floor muscle therapy, etc.)
- Patient BMI ≥ 35.
- Patient routinely has more than 2 episodes of awakening to void during normal sleeping hours.
- If taking a medication known to affect lower urinary tract function, including but not limited to, anticholinergics, beta 3 adrenergic receptor agonists, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitor (SNRI) or selective serotonin reuptake inhibitor (SSRI) antidepressants, diuretics, or alpha-adrenergic blockers, patient cannot be maintained on a stable dose and/or frequency of medication (including diuretics), cannot be maintained on a stable dose and/or frequency for at least 2 weeks prior to screening or is likely to change during the course of the study.
- History of cancer in pelvic organs, ureters, or kidneys.
- Patient is pregnant, lactating, or plans to become pregnant during the course of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AMDC-USR (iltamiocel) AMDC-USR (iltamiocel) Autologous muscle-derived cells for urinary sphincter repair (AMDC-USR; generic name: iltamiocel) is the study product. Placebo Placebo Placebo control is the vehicle solution used for the study product.
- Primary Outcome Measures
Name Time Method Number of leaks due to stress incontinence episodes, as recorded in a diary 12 months Stress leak frequency
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Northwell Health/The Arthur Smith Institute for Urology
🇺🇸Lake Success, New York, United States
Arizona Urology Specialists
🇺🇸Tucson, Arizona, United States
San Diego Clinical Trials
🇺🇸La Mesa, California, United States
UCLA Women's Health Clinical Research Unit/Department of OBGYN
🇺🇸Los Angeles, California, United States
Stanford Hospital and Clinics
🇺🇸Stanford, California, United States
American Association of Female Pelvic Medicines Research Institute
🇺🇸Westlake Village, California, United States
MedStar Georgetown Hospital Department of Urology
🇺🇸Washington, District of Columbia, United States
University of Kansas Health System
🇺🇸Kansas City, Kansas, United States
Bennett Institute of Urogynecology and Incontinence
🇺🇸Grand Rapids, Michigan, United States
University of New Mexico Women's Care Clinic
🇺🇸Albuquerque, New Mexico, United States
AccuMed Research Associates
🇺🇸Garden City, New York, United States
Columbia University Irving Medical Center
🇺🇸New York, New York, United States
Atrium Health
🇺🇸Charlotte, North Carolina, United States
Cleveland Clinic/Glickman Institute-Q10
🇺🇸Cleveland, Ohio, United States
Magee Women's Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic
🇺🇸Sioux Falls, South Dakota, United States
Vanderbilt University Medical Center, Dept. of Urologic Surgery
🇺🇸Nashville, Tennessee, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Cedar Health Research
🇺🇸Irving, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Derriford Hospital
🇬🇧Plymouth, Devon, United Kingdom