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Japanese Bridging Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair(JPN1)

Studies

Study First Submitted Date 2019-06-24
Study First Posted Date 2019-06-25
Last Update Posted Date 2023-07-25
Start Month Year June 2024
Primary Completion Month Year June 2025
Verification Month Year July 2023
Verification Date 2023-07-31
Last Update Posted Date 2023-07-25

Detailed Descriptions

Sequence: 20721234
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) 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).

This trial was designed as a confirmatory Phase III study to bridge efficacy and safety data from the Japanese population to the current Phase III global trial for AMDC-USR (CELLBRATE, NCT03104517).

Conditions

Sequence: 52170091
Name Stress Urinary Incontinence
Downcase Name stress urinary incontinence

Id Information

Sequence: 40157896
Id Source org_study_id
Id Value 15-09

Design Groups

Sequence: 55592125 Sequence: 55592126
Group Type Experimental Group Type Placebo Comparator
Title AMDC-USR Title Placebo
Description AMDC-USR is the study product (Autologous Muscle Derived Cells for Urinary Sphincter Repair). Description Placebo control is the vehicle solution used for the study product.

Interventions

Sequence: 52484551 Sequence: 52484552
Intervention Type Biological Intervention Type Other
Name AMDC-USR Name Placebo
Description Autologous Muscle Derived Cells for Urinary Sphincter Repair Description Placebo control is the vehicle solution used for the study product.

Keywords

Sequence: 79867005 Sequence: 79867006 Sequence: 79867007 Sequence: 79867008 Sequence: 79867009 Sequence: 79867010 Sequence: 79867011 Sequence: 79867012 Sequence: 79867013 Sequence: 79867014 Sequence: 79867015
Name Urinary Incontinence Name Urinary Stress Incontinence Name Lower Urinary Tract Symptoms Name Urinary Bladder Name Urinary Tract Diseases Name Bladder Name Urinary Leak Name Urine Leak Name Bladder Leak Name Urethra Name Urethral Spincter
Downcase Name urinary incontinence Downcase Name urinary stress incontinence Downcase Name lower urinary tract symptoms Downcase Name urinary bladder Downcase Name urinary tract diseases Downcase Name bladder Downcase Name urinary leak Downcase Name urine leak Downcase Name bladder leak Downcase Name urethra Downcase Name urethral spincter

Design Outcomes

Sequence: 177375366
Outcome Type primary
Measure Number of leaks due to stress incontinence episodes, as recorded in a diary.
Time Frame 12 months
Description Stress leak frequency

Browse Conditions

Sequence: 193482739 Sequence: 193482740 Sequence: 193482741 Sequence: 193482742 Sequence: 193482743 Sequence: 193482744 Sequence: 193482745 Sequence: 193482746 Sequence: 193482747 Sequence: 193482748 Sequence: 193482749 Sequence: 193482750 Sequence: 193482751 Sequence: 193482752
Mesh Term Urinary Incontinence Mesh Term Enuresis Mesh Term Urinary Incontinence, Stress Mesh Term Urination Disorders Mesh Term Urologic Diseases Mesh Term Female Urogenital Diseases Mesh Term Female Urogenital Diseases and Pregnancy Complications Mesh Term Urogenital Diseases Mesh Term Male Urogenital Diseases Mesh Term Lower Urinary Tract Symptoms Mesh Term Urological Manifestations Mesh Term Behavioral Symptoms Mesh Term Elimination Disorders Mesh Term Mental Disorders
Downcase Mesh Term urinary incontinence Downcase Mesh Term enuresis Downcase Mesh Term urinary incontinence, stress Downcase Mesh Term urination disorders Downcase Mesh Term urologic diseases Downcase Mesh Term female urogenital diseases Downcase Mesh Term female urogenital diseases and pregnancy complications Downcase Mesh Term urogenital diseases Downcase Mesh Term male urogenital diseases Downcase Mesh Term lower urinary tract symptoms Downcase Mesh Term urological manifestations Downcase Mesh Term behavioral symptoms Downcase Mesh Term elimination disorders Downcase Mesh Term mental disorders
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48318361
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Cook MyoSite

Overall Officials

Sequence: 29284795
Role Principal Investigator
Name Melissa Kaufman, M.D., Ph.D.
Affiliation Vanderbilt University Medical Center, Department of Urologic Surgery

Central Contacts

Sequence: 12008644
Contact Type primary
Name Tomoko Kubota
Phone +81-80-4329-0972
Email Tomoko.kubota@iqvia.com
Role Contact

Design Group Interventions

Sequence: 68147971 Sequence: 68147972
Design Group Id 55592125 Design Group Id 55592126
Intervention Id 52484551 Intervention Id 52484552

Eligibilities

Sequence: 30764766
Gender Female
Minimum Age 50 Years
Maximum Age 75 Years
Healthy Volunteers No
Criteria Inclusion Criteria:

Adult female patient 50 to 75 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.
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.

Gender Based True
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253858463
Registered In Calendar Year 2019
Were Results Reported False
Has Single Facility False
Minimum Age Num 50
Maximum Age Num 75
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30510942
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Quadruple
Subject Masked True
Caregiver Masked True
Investigator Masked True
Outcomes Assessor Masked True

Responsible Parties

Sequence: 28877232
Responsible Party Type Sponsor