UMIN-CTR Clinical Trial

Basic information
Public title	A prospective study of preventive effect of tadalafil on urethral stricture after transurethral surgery
Acronym	Preventive effect of tadalafil on urethral stricture after transurethral surgery
Scientific Title	A prospective study of preventive effect of tadalafil on urethral stricture after transurethral surgery
Scientific Title:Acronym	Preventive effect of tadalafil on urethral stricture after transurethral surgery
Region	Japan

Condition
Condition	urethral stricture
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine preventive effect of tadalafil on urethral stricture after transurethral surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Frequency of urethral stricture
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	tadarafil 5mg per day orally
Interventions/Control_2	no medication
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	Not applicable
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	Male patients receiving transurethral surgery
Key exclusion criteria	NO user, allergy to tadalafil and ischemic heart disease
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hisashi Middle name Last name Matsushima
Organization	Tokyo Metropolitan Police Hospital
Division name	Department of Urology
Zip code	164-0001
Address	4-22-1, Nakano, Nakano-ku, Tokyo, Japan
TEL	03-5343-5611
Email	hmatsu53@me.com

Public contact
Name of contact person	1st name Hisashi Middle name Last name Matsushima
Organization	Tokyo Metropolitan Police Hospital
Division name	Department of Urology
Zip code	164-0001
Address	4-22-1, Nakano, Nakano-ku, Tokyo, Japan
TEL	03-5343-5611
Homepage URL	http://www.keisatsubyoin.or.jp/research.html
Email	yakuzai@keisatsubyoin.or.jp

Sponsor
Institute	Hisashi Matsushima Tokyo Metropolitan Police Hospital Department of Urology
Institute
Department

Funding Source
Organization	Hisashi Matsushima Tokyo Metropolitan Police Hospital Department of Urology
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	An Institutional Review Board in TMPH
Address	4-22-1, Nakano, Nakano-ku, Tokyo, Japan
Tel	03-5343-5611
Email	yakuzai@keisatsubyoin.or.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

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 05 Day

Related information
URL releasing protocol	http://www.keisatsubyoin.or.jp/research.html
Publication of results	Unpublished

Result
URL related to results and publications	http://www.keisatsubyoin.or.jp/research.html
Number of participants that the trial has enrolled	60
Results	Under investigation
Results date posted	2021 Year 06 Month 06 Day
Results Delayed	Delay expected
Results Delay Reason	Preparing to submit
Date of the first journal publication of results
Baseline Characteristics	Patients receiving transurethral surgery for BPH
Participant flow	Finished
Adverse events	Nothing
Outcome measures	Risk factor of urethral stricture
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 08 Day
Date of IRB	2017 Year 02 Month 01 Day
Anticipated trial start date	2017 Year 02 Month 09 Day
Last follow-up date	2019 Year 02 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 06 Month 02 Day
Last modified on	2021 Year 06 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031642