Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of TAC-302 in detrusor underactivity patients with overactive bladder.

Detailed Description
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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. Male; bladder contractility index (BCI) Female; projected isovolumetric pressure (PIP) 1

Official Title
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Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder.

Conditions
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Overactive Bladder, Detrusor Underactivity

Intervention / Treatment
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* Drug: TAC-302
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: To have Lower Urinary Tract Symptoms for at least 12 weeks prior to study entry To have at least 1 urinary urgency episodes per day, and diurnal urinary frequency of 8 or more per day. To meet the detrusor underactivity criteria by urodynamic study Key Exclusion Criteria: Neurogenic bladder by the central nervous system diseases. StageIII or more cystocele of pelvic organ prolapse quantification system (women) Prostate volume ≥30mL (Men) Any symptoms of Urinary tract infection (UTI)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAC-302<br> | Drug: TAC-302<br>* TAC-302 200 mg administered orally twice per day after meals, for 12 weeks.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo administered orally twice per day after meals, for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Male; bladder contractility index (BCI) | 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. | 12 weeks | 
| Female; projected isovolumetric pressure (PIP) 1 | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder capacity of first desire to void | The urodynamic parameter of pressure-flow study during filling phase Bladder capacity of first desire to void in milliliters | Baseline, 12 weeks | 
| Bladder compliance | The urodynamic parameter of pressure-flow study during filling phase Bladder compliance in milliliters per centimeters water | Baseline, 12 weeks | 
| Appearance of bladder involuntary contraction | The urodynamic parameter of pressure-flow study during filling phase | Baseline, 12 weeks | 
| Qmax | The urodynamic parameter of pressure-flow study during voiding phase Qmax in milliliters per second | Baseline, 12 weeks | 
| PdetQmax | The urodynamic parameter of pressure-flow study during voiding phase PdetQmax in centimeters water | Baseline, 12 weeks | 
| Bladder contraction duration | The urodynamic parameter of pressure-flow study during voiding phase Bladder contraction duration in seconds | Baseline, 12 weeks | 
| Maximum free flow rate (free Qmax) | The urodynamic parameter of free uroflowmetry Free Qmax in milliliters per second | Baseline, 4 weeks, 8 weeks, 12 weeks | 
| Voided volume | The urodynamic parameter of free uroflowmetry Voided volume in milliliters | Baseline, 4 weeks, 8 weeks, 12 weeks | 
| Voiding time | The urodynamic parameter of free uroflowmetry Voiding time in seconds | Baseline, 4 weeks, 8 weeks, 12 weeks | 
| Post Void Residual | Determining the volume of post void residual by ultrasonography Post Void Residual in milliliters | Baseline, 4 weeks, 8 weeks, 12 weeks | 
| Bladder Voiding Efficiency (BVE) | Voided volume and Post Void Residual will be combined to report BVE BVE(%)=[Voided volume/(Voided volume+ Post Void Residual)]×100 | Baseline, 4 weeks, 8 weeks, 12 weeks | 
| 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 | The bladder diary data | Baseline, 4 weeks, 8 weeks, 12 weeks | 
| Safety assessed by incidence rate and severity of adverse events |  | Up to 13 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower Urinary Tract Symptoms