Stress Urinary Incontinence Clinical Trial
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
Verified date | December 2022 |
Source | Cook MyoSite |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 311 |
Est. completion date | November 10, 2020 |
Est. primary completion date | November 1, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Leuven | Leuven | |
Germany | Universitätsklinikum Essen | Essen | |
Germany | Praxisklinik Urologie Rhein-Ruhr (PUR/R) | Mülheim | |
United States | The American Association of Female Pelvic Medicine Specialists | Agoura Hills | California |
United States | Emory University | Atlanta | Georgia |
United States | Montefiore Medical Center | Bronx | New York |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | McKay Urology | Charlotte | North Carolina |
United States | The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital | Cincinnati | Ohio |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Inova Fairfax Hospital | Falls Church | Virginia |
United States | Female Pelvic Medicine & Urogynecology Institute of Michigan | Grand Rapids | Michigan |
United States | Mercy Health Saint Mary's Campus | Grand Rapids | Michigan |
United States | Greenville Health System | Greenville | South Carolina |
United States | Methodist Urology Associates | Houston | Texas |
United States | IU Health Physicians Urogynecology | Indianapolis | Indiana |
United States | Ronald Reagan UCLA Medical Center | Los Angeles | California |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | NYU Urology Associates | New York | New York |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Mayo Clinic Arizona Phoenix Campus | Phoenix | Arizona |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | Premier Medical Group of the Hudson Valley PC | Poughkeepsie | New York |
United States | William Beaumont Hospital | Royal Oak | Michigan |
United States | Benaroya Research Institute at Virginia Mason | Seattle | Washington |
United States | Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic | Sioux Falls | South Dakota |
United States | NorthShore University HealthSystem | Skokie | Illinois |
United States | Stanford University | Stanford | California |
United States | Cleveland Clinic Florida | Weston | Florida |
Lead Sponsor | Collaborator |
---|---|
Cook MyoSite |
United States, Belgium, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency | Spearman's correlation used for analysis | Baseline and 12 months | |
Other | Treatment Durability at 24 Months | Treatment durability defined as iltamiocel-treated participants with reduction in stress incontinence episode frequency (SIEF) at 12 months who maintained that response at 24 months | Baseline, 12 months, and 24 months after injection with iltamiocel | |
Primary | Participants With = 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary | Baseline and 12 months | ||
Secondary | Participants With at = 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months | Baseline and 12 months | ||
Secondary | Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months | Baseline and 12 months | ||
Secondary | Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months | Baseline and 12 months |
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