Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder.
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of TAC-302 in detrusor underactivity patients with overactive bladder.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The main purpose of this study is to assess the efficacy of TAC-302 for 12 weeks in detrusor underactivity patients with overactive bladder by measuring the following parameters of pressure-flow study.
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Male; bladder contractility index (BCI)
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Female; projected isovolumetric pressure (PIP) 1
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TAC-302
|
Drug: TAC-302
TAC-302 200 mg administered orally twice per day after meals, for 12 weeks.
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Placebo administered orally twice per day after meals, for 12 weeks.
|
Outcome Measures
Primary Outcome Measures
- Male; bladder contractility index (BCI) [12 weeks]
Pressure-flow study parameters of the detrusor pressure at maximum flow rate (PdetQmax) and the maximum flow rate (Qmax) will be combined to report BCI. BCI=PdetQmax + 5Qmax The detrusor pressure at maximum flow rate (PdetQmax) in centimeters water, the maximum flow rate (Qmax) in milliliters per second.
- Female; projected isovolumetric pressure (PIP) 1 [12 weeks]
Pressure-flow study parameters of the detrusor pressure at maximum flow rate (PdetQmax) and the maximum flow rate (Qmax) will be combined to report PIP1. PIP1=PdetQmax + Qmax The detrusor pressure at maximum flow rate (PdetQmax) in centimeters water, the maximum flow rate (Qmax) in milliliters per second.
Secondary Outcome Measures
- Bladder capacity of first desire to void [Baseline, 12 weeks]
The urodynamic parameter of pressure-flow study during filling phase Bladder capacity of first desire to void in milliliters
- Bladder compliance [Baseline, 12 weeks]
The urodynamic parameter of pressure-flow study during filling phase Bladder compliance in milliliters per centimeters water
- Appearance of bladder involuntary contraction [Baseline, 12 weeks]
The urodynamic parameter of pressure-flow study during filling phase
- Qmax [Baseline, 12 weeks]
The urodynamic parameter of pressure-flow study during voiding phase Qmax in milliliters per second
- PdetQmax [Baseline, 12 weeks]
The urodynamic parameter of pressure-flow study during voiding phase PdetQmax in centimeters water
- Bladder contraction duration [Baseline, 12 weeks]
The urodynamic parameter of pressure-flow study during voiding phase Bladder contraction duration in seconds
- Maximum free flow rate (free Qmax) [Baseline, 4 weeks, 8 weeks, 12 weeks]
The urodynamic parameter of free uroflowmetry Free Qmax in milliliters per second
- Voided volume [Baseline, 4 weeks, 8 weeks, 12 weeks]
The urodynamic parameter of free uroflowmetry Voided volume in milliliters
- Voiding time [Baseline, 4 weeks, 8 weeks, 12 weeks]
The urodynamic parameter of free uroflowmetry Voiding time in seconds
- Post Void Residual [Baseline, 4 weeks, 8 weeks, 12 weeks]
Determining the volume of post void residual by ultrasonography Post Void Residual in milliliters
- Bladder Voiding Efficiency (BVE) [Baseline, 4 weeks, 8 weeks, 12 weeks]
Voided volume and Post Void Residual will be combined to report BVE BVE(%)=[Voided volume/(Voided volume+ Post Void Residual)]×100
- The changes in the international prostate symptom score (IPSS) [Baseline, 4 weeks, 8 weeks, 12 weeks]
- The changes in the overactive bladder symptom score (OABSS) [Baseline, 4 weeks, 8 weeks, 12 weeks]
- The changes in the king's health questionnaire (KHQ) [Baseline, 12 weeks]
- The changes in mean urinary frequency per day, mean frequency of urgency and urge urinary incontinence episodes per day [Baseline, 4 weeks, 8 weeks, 12 weeks]
The bladder diary data
- Safety assessed by incidence rate and severity of adverse events [Up to 13 Weeks]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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To have Lower Urinary Tract Symptoms for at least 12 weeks prior to study entry
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To have at least 1 urinary urgency episodes per day, and diurnal urinary frequency of 8 or more per day.
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To meet the detrusor underactivity criteria by urodynamic study
Key Exclusion Criteria:
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Neurogenic bladder by the central nervous system diseases.
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StageIII or more cystocele of pelvic organ prolapse quantification system (women)
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Prostate volume ≥30mL (Men)
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Any symptoms of Urinary tract infection (UTI)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Taiho Pharmaceutical Co., Ltd selected site | Kumamoto | Japan |
Sponsors and Collaborators
- Taiho Pharmaceutical Co., Ltd.
Investigators
- Study Director: Taiho Pharmaceutical Co., Ltd, Taiho Pharmaceutical Co., Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 10054040