UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036799 |
|---|---|
| Receipt number | R000041913 |
| Scientific Title | Research for predictors of the efficacy of add-on therapy for overactive bladder symptoms in men treated for lower urinary tract symptoms |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2019/05/17 12:23:23 |
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Basic information
Public title
Research for predictors of the efficacy of add-on therapy for overactive bladder symptoms in men treated for lower urinary tract symptoms
Acronym
Research for predictors of the efficacy of add-on therapy for overactive bladder symptoms in men treated for lower urinary tract symptoms
Scientific Title
Research for predictors of the efficacy of add-on therapy for overactive bladder symptoms in men treated for lower urinary tract symptoms
Scientific Title:Acronym
Research for predictors of the efficacy of add-on therapy for overactive bladder symptoms in men treated for lower urinary tract symptoms
Region
| Japan |
Condition
Condition
Benign Prostatic Hyperplasia
Overactive Bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate useful predictors of add-on therapy for overactive bladder symptoms in male lower urinary tract symptoms
Basic objectives2
Others
Basic objectives -Others
Uroflowmetry, ultrasonography, the 24-h frequency-volume charts are used to study predictors of add-on therapy for overactive bladder symptoms in male lower urinary tract symptoms
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The factors associated with residual overactive bladder symptoms eight weeks after the start of add-on therapy in male lower urinary tract symptoms patient
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | > |
Gender
Male
Key inclusion criteria
The patient with lower urinary tract symptoms and benigh prostatic hyperplasia (Prostate volume is over 20mL.)
Key exclusion criteria
We excluded the patient had urinary tract infection, suspected urinary tract malignancy, treatment history of urinary tract malignancy and urinary tract surgery history.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Kojima |
Organization
Fukushima Medical University School of Medicine
Division name
Department of Urology
Zip code
960-1295
Address
1-Hikarigaoka, Fukushima
TEL
024-547-1316
urol@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Matsuoka |
Organization
Fukushima Medical University School of Medicine
Division name
Department of Urology
Zip code
960-1295
Address
1-Hikarigaoka, Fukushima
TEL
024-547-1316
Homepage URL
kanaco@fmu.ac.jp
Sponsor or person
Institute
Department of Urology, Fukushima Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University School of Medicine
Address
1-Hikarigaoka, Fukushima
Tel
024-547-1316
kanaco@fmu.ac.jp
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
| 2019 | Year | 07 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Design:Cohort Study
Recruitment:All patients who visited our facility or collaborative research facility, and met our selection criteria in April-2022 March 2019.
Management information
Registered date
| 2019 | Year | 05 | Month | 20 | Day |
Last modified on
| 2019 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041913
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
