UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004843 |
|---|---|
| Receipt number | 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 10:13:16 |
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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
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
Sponsor or person
Institute
Keio University Shool of Medicine
Department of Urology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005698
