UMIN-CTR Clinical Trial

Basic information
Public title	Add-on effects of tadalafil for tamsulosin treated patients with benign prostatic hyperplasia suffering from residual lower urinary tract symptoms: a randomized, placebo-controlled, double-blind, crossover study
Acronym	Add-on effects of tadalafil for tamsulosin treated patients with residual LUTS: a randomized, placebo-controlled, double-blind, crossover study
Scientific Title	Add-on effects of tadalafil for tamsulosin treated patients with benign prostatic hyperplasia suffering from residual lower urinary tract symptoms: a randomized, placebo-controlled, double-blind, crossover study
Scientific Title:Acronym	Add-on effects of tadalafil for tamsulosin treated patients with residual LUTS: a randomized, placebo-controlled, double-blind, crossover study
Region	Japan

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

Objectives
Narrative objectives1	To investigate the add-on effects of tadalafil for tamsulosin treated patients with benign prostatic hyperplasia suffering from residual lower urinary tract symptoms by a randomized, placebo-controlled, double-blind, crossover study
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Differences of total IPSS score from baseline to cross over treatment of tadalafil and placebo for 6 weeks each
Key secondary outcomes	1) Changes in questionnaire parameters (IPSS-QOL, IIEF) 2) Changes in uroflowmetry parameters (voided volume, Qmax, residual urine) 3) Changes in voiding diary (frequency per day, frequency at daytime, frequency at night, urine volume per day and average voided volume) 4) Safety, adverse events and side effects

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	tadalafil for 6 weeks followed by placebo 6 weeks
Interventions/Control_2	tadalafil for 6 weeks following to placebo 6 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	1) Patients who agree with this study 2) 50 years old men and elder 3) Diagnosed as benign prostatic hyperplasia using a standard method 4) Prostatic volume is between 20ml and 40ml 5) Patients who have IPSS total score no less than 8 and QOL no less than 3 under treatment of tamsulosin 0.2mg for at least 4 weeks.
Key exclusion criteria	1) Patients with prostate cancer, neurogenic bladder, urethral stricture, chronic prostatitis, urinary tract infections, urinary tract stones or interstitial cystitis. 2) Patients with a contraindication for tadarafil 3) Patients taking silodosin or naftopidil, or in 2 weeks after stopping those two. 4) Patients taking dutasteride, or in 3 months after stopping dutasteride. 5) Patients taking anticholinergics, or in 2 weeks after stopping them. 6) Patients who are diagnosed as not applicable to this study by an attending doctor.
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hiromitsu Negoro
Organization	Kyoto University, Graduate School of Medicine
Division name	Urology
Zip code
Address	Shogoin kawahara-cho 54, Kyoto Sakyo-ku,
TEL	075-751-3337
Email	hnegoro@kuhp.kyoto-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Hiromitsu Negoro
Organization	Kyoto University, Graduate School of Medicine
Division name	Urology
Zip code
Address	Shogoin kawahara-cho 54, Kyoto Sakyo-ku,
TEL	075-751-3337
Homepage URL
Email	hnegoro@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Urology, Kyoto University, Graduate School of Medicine
Institute
Department

Funding Source
Organization	donation money for research
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
Address
Tel
Email

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	京都大学医学部附属病院（京都府）

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 01 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	Completed
Date of protocol fixation	2014 Year 07 Month 15 Day
Date of IRB	2014 Year 09 Month 19 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date	2018 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 08 Month 05 Day
Last modified on	2019 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017176