UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007832
Receipt No. R000009230
Scientific Title Optimum time for catheter removal after HoLEP
Date of disclosure of the study information 2012/04/27
Last modified on 2016/01/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Optimum time for catheter removal after HoLEP
Acronym Optimum time for catheter removal after HoLEP
Scientific Title Optimum time for catheter removal after HoLEP
Scientific Title:Acronym Optimum time for catheter removal after HoLEP
Region
Japan

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

Objectives
Narrative objectives1 To prospectively evaluate the optimum time for removal of the urethral catheter following the HoLEP in patients with benign prostatic hyperplasia (BPH)
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes To determine the optimum time for removal of the urethral catheter following the HoLEP
Key secondary outcomes Complications and dysuria after catheter removal

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Patients' catheters are removed on postoperative day 2.
Interventions/Control_2 Patients' catheters are removed on postoperative day 1.
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
40 years-old <
Age-upper limit
90 years-old >
Gender Male
Key inclusion criteria patients with benign prostatic hyperplasia (BPH) who undergo HoLEP
Key exclusion criteria no history of transurethral surgery of the prostate
no medication of anticoagulants
Target sample size 176

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takaharu Ichikawa
Organization Tottori Municipal Hospital
Division name Urology
Zip code
Address 1-1 Matoba Tottori City
TEL 0857-37-1522
Email takaharuichikawa@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takaharu Ichikawa
Organization Tottori Municipal Hospital
Division name Urology
Zip code
Address 1-1 Matoba Tottori City, Japan
TEL 0857-37-1522
Homepage URL
Email takaharuichikawa@yahoo.co.jp

Sponsor
Institute Department of Urology, Tottori Municipal Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 鳥取市立病院(鳥取県)

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 27 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
It it hard to keep the protocol strictly because the main proctor was out.
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 Terminated
Date of protocol fixation
2012 Year 04 Month 24 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 01 Day
Date trial data considered complete
2013 Year 04 Month 01 Day
Date analysis concluded
2013 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 04 Month 24 Day
Last modified on
2016 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009230

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.