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

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

Study Overview

• Status: Completed
• Conditions: Overactive Bladder; Detrusor Underactivity
• Intervention / Treatment: Drug: TAC-302; Drug: Placebo

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.

• Male; bladder contractility index (BCI)
• Female; projected isovolumetric pressure (PIP) 1

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Kumamoto, Japan
    • Taiho Pharmaceutical Co., Ltd selected site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taiho Pharmaceutical Co., Ltd.
• Investigators: Study Director: Taiho Pharmaceutical Co., Ltd, Taiho Pharmaceutical Co., Ltd.

Publications and helpful links

General Publications

• Yoshida M, Gotoh M, Yokoyama O, Kakizaki H, Yamanishi T, Yamaguchi O. Efficacy of TAC-302 for patients with detrusor underactivity and overactive bladder: a randomized, double-blind, placebo-controlled phase 2 study. World J Urol. 2022 Nov;40(11):2799-2805. doi: 10.1007/s00345-022-04163-4. Epub 2022 Oct 7.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): March 27, 2020

Study Registration Dates

• First Submitted: May 25, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Lower Urinary Tract Symptoms
• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Neurologic Manifestations; Dyskinesias; Urinary Bladder, Overactive; Hypokinesia; Urinary Bladder, Underactive
• Other Study ID Numbers: 10054040

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No