The purpose of this study is to determine if TAR-302-5018, an investigational drug-delivery system, is safe and tolerable in patients with neurogenic detrusor overactivity (NDO) resulting from spinal cord injury (SCI).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
TAR-302-5018 is a passive, nonresorbable trospium-releasing intravesical system whose primary mode of action is the controlled release of trospium into the bladder over a 42-day period.
Michigan Institute of Urology
Troy, Michigan, United States
Carolinas HealthCare System
Charlotte, North Carolina, United States
Urology of Virginia
Virginia Beach, Virginia, United States
Virginia Mason
Seattle, Washington, United States
Safety of TAR-302-5018: Safety will be assessed throughout the study based on reported AEs
Safety will be assessed throughout the study based on reported AEs, investigational product events (IPEs), physical examinations (PEs), vital signs, clinical laboratory tests, scheduled cystoscopic examinations, bladder ultrasounds, bladder post-void residual volume (PVR), and the use of concomitant medications.
Time frame: Safety will be assessed from the signing of the informed consent form through Study Day 49 (+ 7 days) for a total of up to 77 days.
Tolerability of TAR-302-5018
Tolerability will be determined by the proportion of subjects who require TAR-302-5018 removal prior to the planned removal on Day 42 due to meeting any of the Subject Stopping Safety Criteria or other drug or device constituent related adverse event.
Time frame: Tolerability will be assessed during the 42-day indwelling period unless removed due to lack of tolerability in advance of the Day 42 scheduled removal.
Peak Plasma Concentration (Cmax)
Plasma will be evaluated for trospium levels on Study Days 0, 3, 7, 14, 28, 42, and 49.
Time frame: Seven time-points across 49 days (Day 0 through Day 49).
Peak Urine Concentration (Cmax)
Urine will be evaluated for trospium levels on Study Days 0, 3, 7, 14, 28, 42, and 49.
Time frame: Seven time-points across 49 days (Day 0 through Day 49).
Preliminary Urodynamic Efficacy: Vesical Filling Phase - Instillation Volume
Instillation volume at first sensation (mL)
Time frame: Day 0, Day 14 (+/- 1 day), Day 42
Preliminary Urodynamic Efficacy: Vesical Filling Phase - Vesical Pressure
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Vesical pressure at first sensation (cmH2O)
Time frame: Day 0, Day 14 (+/- 1 day), Day 42
Preliminary Urodynamic Efficacy: Vesical Filling Phase - Instillation Volume
Instillation volume at first desire to urinate (mL)
Time frame: Day 0, Day 14 (+/- 1 day), Day 42
Preliminary Urodynamic Efficacy: Vesical Filling Phase - Vesical Pressure
Vesical pressure at first desire to urinate (cmH2O)
Time frame: Day 0, Day 14 (+/- 1 day), Day 42
Preliminary Urodynamic Efficacy: Vesical Filling Phase - Instillation Volume
Instillation volume at maximal desire to urinate (mL)
Time frame: Day 0, Day 14 (+/- 1 day), Day 42
Preliminary Urodynamic Efficacy: Vesical Filling Phase - Vesical Pressure
Vesical pressure at maximal desire to urinate (cmH2O)
Time frame: Day 0, Day 14 (+/- 1 day), Day 42
Preliminary Urodynamic Efficacy: Vesical Filling Phase - Instillation Volume
Instillation volume at maximum capacity (mL)
Time frame: Day 0, Day 14 (+/- 1 day), Day 42
Preliminary Urodynamic Efficacy: Vesical Filling Phase - Detrusor Pressure
Detrusor pressure at maximum capacity (cmH2O)
Time frame: Day 0, Day 14 (+/- 1 day), Day 42
Preliminary Urodynamic Efficacy: Vesical Filling Phase - Bladder Compliance
Bladder compliance (mL/cmH2O)
Time frame: Day 0, Day 14 (+/- 1 day), Day 42
Preliminary Urodynamic Efficacy: Involuntary Bladder Contractions - Instillation Volume
Instillation Volume (mL)
Time frame: Day 0, Day 14 (+/- 1 day), Day 42
Preliminary Urodynamic Efficacy: Involuntary Bladder Contractions - Vesical Pressure
Vesical pressure (cmH2O)
Time frame: Day 0, Day 14 (+/- 1 day), Day 42
Preliminary Urodynamic Efficacy: Involuntary Bladder Contractions - Detrusor Pressure
Detrusor pressure (cmH2O)
Time frame: Day 0, Day 14 (+/- 1 day), Day 42
Preliminary Urodynamic Efficacy: Vesical Voiding Phase - Peak Flow
Peak flow (mL/s)
Time frame: Day 0, Day 14 (+/- 1 day), Day 42
Preliminary Urodynamic Efficacy: Vesical Voiding Phase - Mean Flow
Mean flow (mL/s)
Time frame: Day 0, Day 14 (+/- 1 day), Day 42
Preliminary Urodynamic Efficacy: Vesical Voiding Phase - Detrusor Pressure
Detrusor pressure at the peak flow (cmH2O)
Time frame: Day 0, Day 14 (+/- 1 day), Day 42
Preliminary Urodynamic Efficacy: Vesical Voiding Phase - Total Voided Volume
Total voided volume (mL)
Time frame: Day 0, Day 14 (+/- 1 day), Day 42
Preliminary Urodynamic Efficacy: Vesical Voiding Phase - Post Void Residual Volume
Post void residual volume (mL)
Time frame: Day 0, Day 14 (+/- 1 day), Day 42