UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the efficacy and safety of tadalafil and imidafenacin combination therapy for benign prostatic hyperplasia with overactive bladder
Title of the study (Brief title)	Study of the efficacy and safety of tadalafil and imidafenacin combination therapy for benign prostatic hyperplasia with overactive bladder
Region	Japan

Condition
Condition	Benign prostatic hyperplasia patients with overactive bladder despite tadalafil treatment
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to enhance the treatment options for benign prostatic hyperplasia patients with persisting overactive bladder even after treatment with tadalafil by investigating the efficacy and safety of adding imidafenacin
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The OABSS total score from baseline to 8 weeks
Key secondary outcomes	(1) OABSS subscore (2) IPSS total, storage, voiding, QOL score (3) BII (4) Residual urine volume (5) Maximum urinary flow rate (6) Adverse events and side effects

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intervention group: imidafenacin(0.1 mg twice a day) will be additionally prescribed for 8 weeks to patients currently taking tadalafil(5mg/day)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	50 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	Patients must satisfy the following conditions at the first visit: (1) 50 years old or above (at the time of obtaining consent) (2) Overactive bladder despite taking tadalafil 5 mg per day for 4 weeks or more (OAB definition: 2 points or more for question 3 of the OABSS and 3 points or more for the OABSS total score) (3) Prostate volume of at least 20 mL (4) Outpatient (5) Provided written consent for participation in this study
Key exclusion criteria	Patients who meet any of the following conditions at the first visit are excluded: (1) Residual urine volume of 100 mL or more (2) Suspicion of polyuria (3) Currently have, or have a past history of, urinary retention (4) Qmax of less than 5 mL/s (5) Neoplasm of the lower urinary tract such as prostate or bladder cancer, neurogenic bladder, urethral stricture, chronic bacterial prostatitis, urinary tract infection, urinary tract stone, or interstitial cystitis (6) Contraindication to the prescription of tadalafil or imidafenacin (7) Severe liver dysfunction, kidney dysfunction, or heart disease (8) Pyloric, duodenal, or other intestinal obstruction, decreased gastrointestinal motility or distention, paralytic ileus, closed angle glaucoma, or myasthenia gravis (9) Taking a prohibited concurrent medication within 4 weeks prior to starting the study (5&alpha-reductase inhibitor, sex hormone agent within 6 months) (10) Received a prohibited concurrent therapy within 8 weeks prior to starting the study (11) Change in dose or regimen within 8 weeks prior to starting the study of a concurrent restricted medication or therapy (12) Otherwise, determined to be inappropriate by the doctor
Target sample size	30

Research contact person
Name of lead principal investigator	Kazuya Kawahara
Organization	Kawahara Clinic
Division name	Department of urolog
Address	73-3,Nishimochida,Aira-city,Kagoshima 889-5431.Japan
TEL	099-564-5181
Email	kazi@kawahara.or.jp

Public contact
Name of contact person	Kazuya Kawahara
Organization	Kawahara Clinic
Division name	Department of urology
Address	73-3,Nishimochida,Aira-city,Kagoshima 889-5431.Japan
TEL	099-564-5181
Homepage URL
Email	kazi@kawahara.or.jp

Sponsor
Institute	Kawahara Clinic
Institute
Department

Funding Source
Organization	Kyorin Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 12 Day
Anticipated trial start date	2016 Year 04 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 18 Day
Last modified on	2017 Year 03 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025291