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

NCT03997318 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: 15-09
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a confirmatory/bridging study to evaluate the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) compared with placebo in the treatment of stress urinary incontinence (SUI) in adult Japanese female subjects. Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive placebo.

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 Spincter

Outcome Measures

Primary Outcomes (1)

• Number of leaks due to stress incontinence episodes, as recorded in a diary.

  Stress leak frequency

  12 months

Study Arms (2)

AMDC-USR

EXPERIMENTAL

AMDC-USR is the study product (Autologous Muscle Derived Cells for Urinary Sphincter Repair).

Biological: AMDC-USR

Placebo

PLACEBO COMPARATOR

Placebo control is the vehicle solution used for the study product.

Other: Placebo

Interventions

AMDC-USR BIOLOGICAL

Autologous Muscle Derived Cells for Urinary Sphincter Repair

AMDC-USR

Placebo OTHER

Placebo control is the vehicle solution used for the study product.

Placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cook MyoSite: lead

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence; Lower Urinary Tract Symptoms; Urologic Diseases; Nocturnal Enuresis

Condition Hierarchy (Ancestors)

Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Enuresis; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Melissa Kaufman, M.D., Ph.D.

  Vanderbilt University Medical Center, Department of Urologic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 25, 2019
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share