The purpose of this study is to evaluate the efficacy and safety of TAC-302 in detrusor underactivity patients with overactive bladder.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
195
Taiho Pharmaceutical Co., Ltd selected site
Kumamoto, Japan
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.
Time frame: 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.
Time frame: Baseline to Week 12
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.
Time frame: 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.
Time frame: 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)
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Number of Participants With Adverse Drug Reactions
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)