UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of tadalafil monotherapy and its combination with mirabegron for efficacy in the treatment of storage symptoms with benign prostatic hyperplasia
Acronym	Comparison of tadalafil monotherapy and its combination with mirabegron for efficacy in the treatment of storage symptoms with benign prostatic hyperplasia
Scientific Title	Comparison of tadalafil monotherapy and its combination with mirabegron for efficacy in the treatment of storage symptoms with benign prostatic hyperplasia
Scientific Title:Acronym	Comparison of tadalafil monotherapy and its combination with mirabegron for efficacy in the treatment of storage symptoms with benign prostatic hyperplasia
Region	Japan

Condition
Condition	Benign prostatic hyperplasia
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of tadalafil monotherapy and its combination with mirabegron for storage symptoms with benign prostatic hyperplasia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overactive bladder symptom score (OABSS)
Key secondary outcomes	Number of night urination International prostate symptom score Overactive bladder-questionnaire (OAB-q) Nocturia-quality of life (N-QOL)

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A monotherapy group, which continuously received 5 mg tadalafil daily for 8 weeks.
Interventions/Control_2	An add-on group, which received 5mg tadalafil daily and 50 mg mirabegron daily for 4 weeks after 5 mg tadalafil daily for 4 weeks.
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	The study included men with benign prostatic hyperplasia. Inclusion criteria are total OABSS 3 or greater with urinary urgency at least once per week, IPSS question 7 score 2 or greater and age 50 years or greater.
Key exclusion criteria	Study exclusion criteria are post-void residual urine volume greater than 100 ml, acute urinary retention, neurogenic bladder dysfunction, severe bladder diverticulum or urethral stricture, urinary tract malignant disease, previous intrapelvic irradiation, renal or hepatic impairment, severe cardiac disease, or considered unsuitable for the trial by doctors.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Masashi Middle name Last name Honda
Organization	Department of Surgery, Tottori University Faculty of Medicine
Division name	Dvision of Urology
Zip code	6838504
Address	36-1 Nishicho, Yonago, Tottori, Japan
TEL	0859-38-6607
Email	honda@tottori-u.ac.jp

Public contact
Name of contact person	1st name Masashi Middle name Last name Honda
Organization	Department of Surgery, Tottori University Faculty of Medicine
Division name	Dvision of Urology
Zip code	6838504
Address	36-1 Nishicho, Yonago, Tottori, Japan
TEL	0859-38-6607
Homepage URL
Email	honda@tottori-u.ac.jp

Sponsor
Institute	Division of Urology, Department of Surgery, Tottori University Faculty of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tottori University Faculty of Medicine Ethics Committee
Address	36-1 Nishicho, Yonago, Tottori, Japan
Tel	0859-33-1111
Email	me-rinshoukenkyu@ml.adm.tottori-u.ac.jp

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	鳥取大学医学部附属病院（鳥取県）、鳥取赤十字病院（鳥取県）、鳥取県立中央病院（鳥取県）、山陰労災病院（鳥取県）、米子医療センター（鳥取県）、済生会境港病院（鳥取県）、松江市立病院（島根県）、松江赤十字病院（島根県）、松江生協病院（島根県）、浜田医療センター（島根県）、津山第一病院（岡山県）、吉野三宅ステーションクリニック（鳥取県）、わたなべクリニック（鳥取県）、みはらクリニック（鳥取県）、山本泌尿器クリニック（鳥取県）

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 08 Month 04 Day
Date of IRB	2016 Year 08 Month 04 Day
Anticipated trial start date	2016 Year 08 Month 22 Day
Last follow-up date	2019 Year 07 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 12 Month 25 Day
Last modified on	2020 Year 01 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034891