UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001089 |
|---|---|
| Receipt number | R000001320 |
| Scientific Title | Effect of tiotropium on urinary retention in chronic obstructive pulmonary disease with micturition disorder |
| Date of disclosure of the study information | 2008/03/19 |
| Last modified on | 2008/12/08 22:14:49 |
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Basic information
Public title
Effect of tiotropium on urinary retention in chronic obstructive pulmonary disease with micturition disorder
Acronym
Effect of tiotropium on urinary retention in COPD with micturition disorder
Scientific Title
Effect of tiotropium on urinary retention in chronic obstructive pulmonary disease with micturition disorder
Scientific Title:Acronym
Effect of tiotropium on urinary retention in COPD with micturition disorder
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether or not inhaled tiotropium increases the urinary retention in COPD patients with micturition disorder
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IPSS (International Prostate Symptom Score)
QOL index
Uroflowmetry
Key secondary outcomes
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
At the initial visit before the treatment and the visit after 4-week tiotropium administration, lower urinary symptoms and QOL were assessed.
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
COPD patients who had been clinically diagnosed with benign prostatic hyperplasia at our institution were enrolled.
Key exclusion criteria
Patients with glaucoma, previous bladder or prostate surgery, bladder or prostate cancer, a history of urinary tract infections and serum prostate-specific antigen over 4 ng/ml were excluded.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kingo Chida |
Organization
Hamamatsu university school of medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
1-20-1, Handayama, Higashiku, Hamamatsu, Shizuoka 431-3192, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hamamatsu university school of medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
TEL
053-435-2263
Homepage URL
Sponsor or person
Institute
Second Division, Department of Internal Medicine, Hamamatsu university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Second Division, Department of Internal Medicine, Hamamatsu university school of medicine
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
| 2008 | Year | 03 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 03 | Month | 19 | Day |
Last modified on
| 2008 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001320
