Clinical trial NCT03175029: Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder.
Official title: Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Detrusor Underactivity
Overactive Bladder
Keywords: Lower Urinary Tract Symptoms
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-05
Enrollment: 195
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: Changes in the Mean BCI for Male From Baseline to Week 12
timeFrame: Baseline to Week 12
measure: Changes in the Mean PIP1 for Female From Baseline to Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Changes in the Mean BVE From Baseline to Week 12 (Overall)
timeFrame: Baseline to Week 12
measure: Changes in the Mean BVE From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 50 mL at Baseline)
timeFrame: Baseline to Week 12
measure: 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)
timeFrame: Baseline to Week 12
measure: Number of Micturitions Per 24 Hours at Baseline and Week 12
timeFrame: Baseline to Week 12
measure: Number of Urinary Urgency Episodes Per 24 Hours at Baseline and Week 12
timeFrame: Baseline to Week 12
measure: Overactive Bladder Symptom Score (OABSS) Total Score at Baseline and Week 12
timeFrame: Baseline to Week 12
measure: Number of Participants With Adverse Events
timeFrame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
measure: Number of Participants With Adverse Drug Reactions
timeFrame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
measure: Number of Participants With Serious Adverse Events
timeFrame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
measure: Number of Participants With Adverse Events Leading to Death
timeFrame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
measure: Number of Participants With Adverse Events Leading to Dose Discontinuation
timeFrame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
measure: Number of Participants With Adverse Events Leading to Dose Interruption
timeFrame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
Other outcomes:
Locations:
city: Kumamoto
country: Japan
facility: Taiho Pharmaceutical Co., Ltd selected site
Study officials:
affiliation: Taiho Pharmaceutical Co., Ltd.
name: Taiho Pharmaceutical Co., Ltd
role: STUDY_DIRECTOR
References:
citation: 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.