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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004843
Receipt No. R000005698
Scientific Title Evaluate of Tolterodine for lower urinary tract syndrome after prostate Brachytherapy
Date of disclosure of the study information 2011/01/20
Last modified on 2011/01/08

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Basic information
Public title Evaluate of Tolterodine for lower urinary tract syndrome after prostate Brachytherapy
Acronym Evaluate and safety of Tolterodine for lower urinary tract syndrome after prostate Brachytherapy
Scientific Title Evaluate of Tolterodine for lower urinary tract syndrome after prostate Brachytherapy
Scientific Title:Acronym Evaluate and safety of Tolterodine for lower urinary tract syndrome after prostate Brachytherapy
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and the safety of combination therapy with Tolerodine for the patient who remained storage symptom treated by alfa-1 blocker after treatment of prostate Brachytherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To verify change rate of Overactive Bladder symptom score(OABSS) after 8week
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Urief tab(4mg b.i.d) 12week
Interventions/Control_2 Detrusitol cap(4mg, daily) 8week
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
80 years-old >
Gender Male
Key inclusion criteria -40<or=age80
-Patient to whom alfa-1-blocker is administered after treatment for prostate brachytherapy
-OABSS(Q3)>or=2, OABSS(total)>or=3
Key exclusion criteria 1. PVR>or=100cc
2. Patient with urinary tract infection
3. Patient of anti-cholinergic medicine administration taboo
a. Patient with urinary retention
b. Patient whose pylorus or duodenum or ileum are obstructed, or who has paralytic ileus
c. Patient whose digestive organ movement or tention are decreased
d. Patient with narrow-angle glaucoma
e. Patient with myasthenia gravis
f. Patient with severe heart disease
g. Patient with sevre hepatic dysfunction (Child-Pugh classification C)
h. Patient with hypersentivity for anti-cholinergic medicine
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirohiko Nagata
Organization Keio University School of Medicine
Division name Department of Urology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hirohiko Nagata
Organization Keio University School of Medicine
Division name Department of Urology
Zip code
Address
TEL 03-3353-1211
Homepage URL
Email

Sponsor
Institute Keio University Shool of Medicine
Department of Urology
Institute
Department

Funding Source
Organization None
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

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 20 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 Enrolling by invitation
Date of protocol fixation
2011 Year 01 Month 06 Day
Date of IRB
Anticipated trial start date
2011 Year 02 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
2011 Year 01 Month 08 Day
Last modified on
2011 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005698

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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