UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010801 |
|---|---|
| Receipt number | 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 00:55:14 |
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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
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
uro051@poh.osaka-med.ac.jp
Sponsor or person
Institute
osaka medical college
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012628
