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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010801
Receipt No. R000012628
Scientific Title Multicentre randomised cotrolled trial comparing bipolar with monopolar transurethral resection of the prostate
Date of disclosure of the study information 2013/05/25
Last modified on 2014/04/13

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Basic information
Public title Multicentre randomised cotrolled trial comparing bipolar with monopolar transurethral resection of the prostate
Acronym Multicentre randomised cotrolled trial comparing bipolar with monopolar transurethral resection of the prostate
Scientific Title Multicentre randomised cotrolled trial comparing bipolar with monopolar transurethral resection of the prostate
Scientific Title:Acronym Multicentre randomised cotrolled trial comparing bipolar with monopolar transurethral resection of the prostate
Region
Japan

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

Objectives
Narrative objectives1 To assess whether bipolar transurethral resection of the prostate using TURis system demonstrate comparable efficacy and safety, considering operation time as primary endpoint and reporting 36 months follow-up findings.
Basic objectives2 Others
Basic objectives -Others To assess if bipolar system has more development of urethral stricture during 36months follow up.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes The primary end point in this study was safety, with a focus on perioperative findings such as operation time, decline of sodium level, clot retention, transfusion, and any other symptom relating to the procedures.
Key secondary outcomes Secondary endpoints were efficacy findings for patients after 36 months of follow-ups including development of urethral stricture.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 monopolar TURP
Interventions/Control_2 bipolar TURP
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 Inclusion criteria were age >50 yr, ECOG performance status less than 3, acute urinary retention if catheter removal failed after therapy with a-blockers or chronic urinary retention unresponsive to medical treatment, International Prostate Symptom Score (IPSS) more than 15.
Key exclusion criteria Exclusion criteria were patients with documented or suspected prostate cancer, bladder calculus, neurogenic bladder, previous prostate surgery, renal impairment, associated hydronephrosis, and urethral stricture.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name komura kazumasa
Organization osaka medical college
Division name urology
Zip code
Address 2-7 Daigaku-machi, Takatsuki, Osaka, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization osaka medical college
Division name urology
Zip code
Address
TEL
Homepage URL
Email uro051@poh.osaka-med.ac.jp

Sponsor
Institute osaka medical college
Institute
Department

Funding Source
Organization osaka medical college
Organization
Division
Category of Funding Organization Self funding
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 大阪医科大学付属病院
市立枚方市民病院
済生会中津病院

Other administrative information
Date of disclosure of the study information
2013 Year 05 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 Completed
Date of protocol fixation
2007 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 25 Day
Last modified on
2014 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012628

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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