UMIN-CTR Clinical Trial

Basic information
Public title	Prospective randomized study of the evaluation of the efficacy and the invasiveness in the treatment of benign prostatic hyperplasia with transurethral thulium laser surgery and transurethral resection of the prostate
Acronym	Prospective randomized study of the evaluation of the efficacy and the invasiveness in the treatment of benign prostatic hyperplasia with transurethral thulium laser surgery and transurethral resection of the prostate
Scientific Title	Prospective randomized study of the evaluation of the efficacy and the invasiveness in the treatment of benign prostatic hyperplasia with transurethral thulium laser surgery and transurethral resection of the prostate
Scientific Title:Acronym	Prospective randomized study of the evaluation of the efficacy and the invasiveness in the treatment of benign prostatic hyperplasia with ThuLEP and TUR-P
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 the invasiveness in the treatment of benign prostatic hyperplasia with transurethral thulium laser surgery and transurethral resection of the prostate in prospective randomized study
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Influence to the urinary function 2. Ocurrence of complications
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
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	Device,equipment Maneuver
Interventions/Control_1	Transurethral thulium laser surgery, about 2 hours
Interventions/Control_2	Transurethral resection of the prostate, about 2 hours
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	90 years-old >
Gender	Male
Key inclusion criteria	1. Age with and larget than 50 years old, less than 90 years old 2. Patient who were diagnosed with benign prostatic hyperplasia 3. Patient who has blodder outlet obstruction due to benign prostatic hyperplasia 4. Patient who who underwent this procedure provided informed consent
Key exclusion criteria	1. Patient who has other disease which has effect to the urinary function 2. Patient who has influence due to pre-operative treatment 3. Patients who was regarded as inadequacy for the present study
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Shoji Middle name Last name Sunao
Organization	Tokai University School of Medicine
Division name	Department of Urology
Zip code	259-1193
Address	Shimokasuya 143, Isehara, Kanagawa
TEL	0463-93-1121
Email	sunashoj@mail.goo.ne.jp

Public contact
Name of contact person	1st name Sunao Middle name Last name Shoji
Organization	Tokai University School of Medicine
Division name	Department of Urology
Zip code	259-1193
Address	Shimokasuya 143, Isehara, Kanagawa
TEL	0463-93-1121
Homepage URL
Email	sunashoj@mail.goo.ne.jp

Sponsor
Institute	Tokai University school of medicine
Institute
Department

Funding Source
Organization	Tokai University school of medicine
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	Institutional Review Board for Clinical Research, Tokai University
Address	143 Shimokasuya, Isehara, Kanagawa
Tel	0463-93-1121
Email	tokai-rinsho@ml.tokai-u.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	東海大学医学部

Other administrative information
Date of disclosure of the study information	2020 Year 03 Month 09 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	2017 Year 03 Month 07 Day
Date of IRB	2017 Year 03 Month 07 Day
Anticipated trial start date	2017 Year 03 Month 07 Day
Last follow-up date	2021 Year 03 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	2020 Year 03 Month 07 Day
Last modified on	2020 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045313