UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the effect of tadalafil on bladder blood flow in patients with lower urinary tract symptoms due to benign prostatic hyperplasia
Title of the study (Brief title)	Effect of tadalafil on bladder blood flow in benign prostatic hyperplasia
Region	Japan

Condition
Condition	Patients with lower urinary tract symptoms due to benign prostatic hyperplasia
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effect of tadalafil on bladder blood flow
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in resistive index of vesical artery on doppler ultrasound at 8 weeks after tadalafil administration
Key secondary outcomes

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	Administration of tadalafil 5mg once per day for 8 weeks
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	75 years-old >
Gender	Male
Key inclusion criteria	I-PSS 13 or more, prostate volume 20ml or more, Qmax on uroflowmetry between 4 ml/sec and 15 ml/sec
Key exclusion criteria	postvoid residual urine 150 ml or more, uncontrolled diabetes mellitus, patients taking medication for lower urinary tract symptoms, patients who underwent surgery or radiation to the prostate
Target sample size	22

Research contact person
Name of lead principal investigator	Hidehiro Kakizaki
Organization	Asahikawa Medical University
Division name	Department of Renal and Urologic Surgery
Address	2-1-1-1 Midorigaoka-Higashi, Asahikawa, Japan
TEL	0166-68-2533
Email	kaki@asahikawa-med.ac.jp

Public contact
Name of contact person	Hidehiro Kakizaki
Organization	Asahikawa Medical University
Division name	Department of Renal and Urologic Surgery
Address	2-1-1-1 Midorigaoka-Higashi, Asahikawa, Japan
TEL	0166-68-2533
Homepage URL
Email	kaki@asahikawa-med.ac.jp

Sponsor
Institute	Hidehiro Kakizaki
Institute
Department

Funding Source
Organization	Asahikawa Medical University, Department of Renal and Urologic Surgery
Organization
Division
Category of Funding Organization	Self funding
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	旭川医科大学病院

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 01 Month 20 Day
Anticipated trial start date	2016 Year 02 Month 01 Day
Last follow-up date	2019 Year 01 Month 20 Day
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 01 Month 20 Day
Last modified on	2019 Year 01 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023845