Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder.
- Conditions
- Detrusor UnderactivityOveractive Bladder
- Interventions
- Drug: Placebo
- Registration Number
- NCT03175029
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of TAC-302 in detrusor underactivity patients with overactive bladder.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 195
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - TAC-302 TAC-302 -
- Primary Outcome Measures
Name Time Method Changes in the Mean BCI for Male From Baseline to Week 12 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.
Changes in the Mean PIP1 for Female From Baseline to Week 12 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.
- Secondary Outcome Measures
Name Time Method Changes in the Mean BVE From Baseline to Week 12 (Overall) Baseline to Week 12 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.
Changes in the Mean BVE From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 50 mL at Baseline) Baseline to Week 12 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.
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) Baseline to Week 12 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.
Number of Micturitions Per 24 Hours at Baseline and Week 12 Baseline to 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.
Number of Urinary Urgency Episodes Per 24 Hours at Baseline and Week 12 Baseline to 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.
Overactive Bladder Symptom Score (OABSS) Total Score at Baseline and Week 12 Baseline to 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.
Number of Participants With Adverse Events Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period) 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.
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 Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period) 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.
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 Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period) 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.
Trial Locations
- Locations (1)
Taiho Pharmaceutical Co., Ltd selected site
🇯🇵Kumamoto, Japan