Stress Urinary IncontinencePhase 3JPN1NCT03997318
Japanese Bridging Study of Autologous Muscle Derived Cells Compared to Placebo for Female Urinary Sphincter Repair(JPN1)
A Phase 3 study testing AMDC-USR in people with Stress Urinary Incontinence, run by Cook MyoSite.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- AMDC-USR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Jun 2027
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: JPN1: A Confirmatory, Bridging, Double-Blind, Randomized, Controlled Trial in Japan Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence
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.
Read the 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) 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
- Stress Urinary Incontinence
- Being tested
- AMDC-USR, Placebo
- 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
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence, Lower Urinary Tract Symptoms, Urologic Diseases, Nocturnal Enuresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMDC-USRBiological
Autologous Muscle Derived Cells for Urinary Sphincter Repair
PlaceboOther
Placebo control is the vehicle solution used for the study product.
| Study group | Role | What they receive |
|---|---|---|
| AMDC-USR | Experimental | AMDC-USR is the study product (Autologous Muscle Derived Cells for Urinary Sphincter Repair). Receives: Biological: AMDC-USR |
| Placebo | Placebo comparator | Placebo control is the vehicle solution used for the study product. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of leaks due to stress incontinence episodes, as recorded in a diary.
Stress leak frequency
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study startJun 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Why it stopped: Study not initiated due to business decision, no participants enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook MyoSite
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melissa Kaufman, M.D., Ph.D., Principal investigator, Vanderbilt University Medical Center, Department of Urologic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997318
- Sponsor's protocol ID
- 15-09
- Acronym
- JPN1
- Status last verified
- Aug 2024
- First submitted
- 24 Jun 2019
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JPN1: A Confirmatory, Bridging, Double-Blind, Randomized, Controlled Trial in Japan Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03997318
- Acronym / sponsor ID
- JPN1 / 15-09
- Conditions
- Stress Urinary Incontinence
- Keywords
- Urinary Incontinence, Urinary Stress Incontinence, Lower Urinary Tract Symptoms, Urinary Bladder, Urinary Tract Diseases, Bladder, Urinary Leak, Urine Leak
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not initiated due to business decision, no participants enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cook MyoSiteIndustry (pharma, biotech, devices)
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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) 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMDC-USR | Experimental | Biological: AMDC-USRAMDC-USR is the study product (Autologous Muscle Derived Cells for Urinary Sphincter Repair). |
| Placebo | Placebo comparator | Other: PlaceboPlacebo control is the vehicle solution used for the study product. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMDC-USRAutologous Muscle Derived Cells for Urinary Sphincter Repair | Biological | AMDC-USR |
| PlaceboPlacebo control is the vehicle solution used for the study product. | Other | Placebo |
Primary outcome
Number of leaks due to stress incontinence episodes, as recorded in a diary.
Time frame: 12 months
Stress leak frequency
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Kaufman, M.D., Ph.D. principal investigator
Vanderbilt University Medical Center, Department of Urologic Surgery
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AMDC-USR in people with Stress Urinary Incontinence, run by Cook MyoSite.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of leaks due to stress incontinence episodes, as recorded in a diary. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.