Clinical trial NCT03104517: Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
Official title: CELLEBRATE: A Double-Blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Persistent or Recurrent Stress Urinary Incontinence Following Surgical Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Stress Urinary Incontinence
Keywords: Urinary Incontinence
Urinary Stress Incontinence
Lower Urinary Tract Symptoms
Urinary Bladder
Urinary Tract Diseases
Bladder
Urinary Leak
Urine Leak
Bladder Leak
Urethra
Urethral Sphincter
Persistent Incontinence
Recurrent Incontinence
Incontinence Surgery
Sling Surgery
Stress Urinary Incontinence Surgery
Lead sponsor: Cook MyoSite
Sponsor class: INDUSTRY
First posted: 2017-04-07
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of leaks due to stress incontinence episodes, as recorded in a diary
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Urology Specialists
state: Arizona
city: La Mesa
country: United States
facility: San Diego Clinical Trials
state: California
city: Los Angeles
country: United States
facility: UCLA Women's Health Clinical Research Unit/Department of OBGYN
state: California
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Westlake Village
country: United States
facility: American Association of Female Pelvic Medicines Research Institute
state: California
city: Washington
country: United States
facility: MedStar Georgetown Hospital Department of Urology
state: District of Columbia
city: Kansas City
country: United States
facility: University of Kansas Health System
state: Kansas
city: Grand Rapids
country: United States
facility: Bennett Institute of Urogynecology and Incontinence
state: Michigan
city: Albuquerque
country: United States
facility: University of New Mexico Women's Care Clinic
state: New Mexico
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
city: Lake Success
country: United States
facility: Northwell Health/The Arthur Smith Institute for Urology
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic/Glickman Institute-Q10
state: Ohio
city: Pittsburgh
country: United States
facility: Magee Women's Hospital of UPMC
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic
state: South Dakota
city: Nashville
country: United States
facility: Vanderbilt University Medical Center, Dept. of Urologic Surgery
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Irving
country: United States
facility: Cedar Health Research
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
state: Devon
Study officials:
affiliation: Vanderbilt University Medical Center, Department of Urologic Surgery
name: Melissa Kaufman, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: