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): 195
• 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: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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
Changes in the Mean BCI for Male From Baseline to Week 12	BCI indicates maxim um detrusor pressure at peak urine flow (PdetQmax) + 5 × peak urine flow rate (Qmax): PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in men, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong > 150, normal 100-150, and weak < 100. No theoretical minimum and maximum value of the scale range exists.	Baseline to Week 12
Changes in the Mean PIP1 for Female From Baseline to Week 12	PIP1 indicates PdetQma x + Qmax: PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in women, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong > 75, normal 30-75, and weak < 30. No theoretical minimum and maximum value of the scale range exists.	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Mean BVE From Baseline to Week 12 (Overall)	BVE indicates Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography.	Baseline to Week 12
Changes in the Mean BVE From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 50 mL at Baseline)	BVE indicates Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography.	Baseline to Week 12
Changes in the Mean BVE for Female From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 100 mL at Baseline)	BVE indicates Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography.	Baseline to Week 12
Number of Micturitions Per 24 Hours at Baseline and Week 12	On the basis of information from bladder diary records in the 3 days directly before each evaluation timepoint, an average of urinations per 24 hours was calculated. The patients with at least 8 urinations per 24 hours at registration were included in this study.	Baseline to Week 12
Number of Urinary Urgency Episodes Per 24 Hours at Baseline and Week 12	On the basis of information from bladder diary records in the 3 days directly before each evaluation timepoint, an average of urinary urgency episodes per 24 hours was calculated. The patients with at least one urinary urgency episode per 24 hours at registration were included in this study.	Baseline to Week 12
Overactive Bladder Symptom Score (OABSS) Total Score at Baseline and Week 12	Overactive bladder symptoms were evaluated using the OABSS. The OABSS Total Score is the sum of four symptom scores: daytime frequency (score 0-2), nighttime frequency (score 0-3), urgency (score 0-5), and urgency incontinence (score 0-5). The range of scores is from 0 to 15 points with a higher score indicating greater severity. A score ≤ 5 was determined to be mild, a score of 6 to 11 was determined to be moderate and a score ≥ 12 was determined to be severe.	Baseline to Week 12
Number of Participants With Adverse Events	In tabulation of adverse events, the diagnoses entered on eCRFs were coded using the medical dictionary for regulatory activities (MedDRA) ver.22.1, and were presented as MedDRA preferred terms.	Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Number of Participants With Adverse Drug Reactions		Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Number of Participants With Serious Adverse Events	In tabulation of adverse events, the diagnoses entered on eCRFs were coded using the medical dictionary for regulatory activities (MedDRA) ver.22.1, and were presented as MedDRA preferred terms.	Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Number of Participants With Adverse Events Leading to Death		Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Number of Participants With Adverse Events Leading to Dose Discontinuation		Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Number of Participants With Adverse Events Leading to Dose Interruption	In tabulation of adverse events, the diagnoses entered on eCRFs were coded using the medical dictionary for regulatory activities (MedDRA) ver.22.1, and were presented as MedDRA preferred terms.	Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)

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): September 9, 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): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Lower Urinary Tract Symptoms
• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Dyskinesias; Urinary Bladder, Underactive; Urinary Bladder, Overactive; Hypokinesia
• 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