Clinical trial NCT01893138: Autologous Muscle Derived Cells for Female Urinary Sphincter Repair
Official title: A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stress Urinary Incontinence
Keywords: Urinary Incontinence, Stress
Tissue Therapy (Cell Therapy)
Transplantation, Autologous
Lead sponsor: Cook MyoSite
Sponsor class: INDUSTRY
First posted: 2013-07-08
Enrollment: 311
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 randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.

Detailed description: Study comparing intrasphincteric injection of iltamiocel with placebo. Subjects unblinded after 12 month visits, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.

Eligibility criteria: Inclusion Criteria:

* Female patient has primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation.

Exclusion Criteria:

* Patient has symptoms of pure 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, etc.)
* Patient has more than 2 episode of awakening to void during normal sleeping hours.
* Patient cannot be maintained on a stable dose and/or frequency of medication (including diuretics) known to affect lower urinary tract function, including but not limited to, anticholinergics, tricyclic antidepressants or alpha-adrenergic blockers, for at least 2 weeks prior to screening or is likely to change during the course of the study.
* Patient is pregnant, lactating, or plans to become pregnant during the course of the study.
* Patient refuses to provide written informed consent.
* Patient is not at least 18 years of age.
* Patient is not available for the follow-up evaluations as required by the protocol.

Primary outcomes:
measure: Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months
timeFrame: Baseline and 12 months
measure: Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months
timeFrame: Baseline and 12 months
measure: Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months
timeFrame: Baseline and 12 months
Other outcomes:
measure: Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency
timeFrame: Baseline and 12 months
measure: Treatment Durability at 24 Months
timeFrame: Baseline, 12 months, and 24 months after injection with iltamiocel
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona Phoenix Campus
state: Arizona
city: Agoura Hills
country: United States
facility: The American Association of Female Pelvic Medicine Specialists
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Skokie
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Indianapolis
country: United States
facility: IU Health Physicians Urogynecology
state: Indiana
city: Grand Rapids
country: United States
facility: Female Pelvic Medicine & Urogynecology Institute of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: Mercy Health Saint Mary's Campus
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: NYU Urology Associates
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley PC
state: New York
city: Charlotte
country: United States
facility: McKay Urology
state: North Carolina
city: Cincinnati
country: United States
facility: The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
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
state: Tennessee
city: Houston
country: United States
facility: Methodist Urology Associates
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Seattle
country: United States
facility: Benaroya Research Institute at Virginia Mason
state: Washington
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Mülheim
country: Germany
facility: Praxisklinik Urologie Rhein-Ruhr (PUR/R)
Study officials:
affiliation: Vanderbilt University Medical Center, Department of Urologic Surgery
name: Melissa Kaufman, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Antosh DD, High R, Brown HW, Oliphant SS, Abed H, Philip N, Grimes CL. Feasibility of prophylactic salpingectomy during vaginal hysterectomy. Am J Obstet Gynecol. 2017 Nov;217(5):605.e1-605.e5. doi: 10.1016/j.ajog.2017.07.017. Epub 2017 Jul 20.