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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013063
Receipt No. R000015239
Scientific Title Therapeutic effect of the drug of Parkinson`s disease on voiding dysfunction
Date of disclosure of the study information 2014/02/07
Last modified on 2015/11/06

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Basic information
Public title Therapeutic effect of the drug of Parkinson`s disease on voiding dysfunction
Acronym Therapeutic effect of the drug of Parkinson`s disease on voiding dysfunction
Scientific Title Therapeutic effect of the drug of Parkinson`s disease on voiding dysfunction
Scientific Title:Acronym Therapeutic effect of the drug of Parkinson`s disease on voiding dysfunction
Region
Japan

Condition
Condition patients with voiding dysfunction such as benign prostatic hyperplasia
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 the efficacy of the drug of Parkinson`s disease on voiding dysfunction
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes voiding efficacy (Qmax)
Key secondary outcomes urinary frequency
questionaires for urinary symptom

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 observation period: 4week
the drug of Parkinson`s disease is administered for 12 weeks
The outcomes is evaluated every 4 weeks

Interventions/Control_2
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 # international prostate symptom score (IPSS): >8
# QOL score: >4
# voided volume >100ml, Qmax: <15ml
# residual volume: <100ml
# eligible for coming to the outpatient clinic
# stable condition
Key exclusion criteria # neurogenic bladder, bladder neck contracture, urethral stricture, urinary tract infection or other complication

# clear intermittent self catheterization
# allergic to the drug
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Teruyuki Ogawa
Organization Shinshu University School of Medicine
Division name Department of urology
Zip code
Address 3-1-1 Asahi Matsumoto Nagano, Japan
TEL 0263-37-2661
Email ogawat@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Teruyuki Ogawa
Organization Shinshu University School of Medicine
Division name Department of urology
Zip code
Address 3-1-1 Asahi Matsumoto Nagano, Japan
TEL 0263-37-2661
Homepage URL
Email ogawat@shinshu-u.ac.jp

Sponsor
Institute Shinshu University School of Medicine
Institute
Department

Funding Source
Organization Department of drug discovery science, Shinshu University School of Medicine
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 07 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 Terminated
Date of protocol fixation
2014 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 07 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
2014 Year 02 Month 03 Day
Last modified on
2015 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015239

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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