UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021414 |
|---|---|
| Receipt number | R000024703 |
| Scientific Title | Study on the effect of combination therapy of alpha-1 blocker and transdermal oxybutynin hydrochloride in patients with overactive bladder due to benign prostatic hyperplasia |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2021/03/14 10:37:37 |
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Basic information
Public title
Study on the effect of combination therapy of alpha-1 blocker and transdermal oxybutynin hydrochloride in patients with overactive bladder due to benign prostatic hyperplasia
Acronym
Study on the combination therapy of alpha-1 blocker and transdermal oxybutynin in patients with overactive bladder due to benign prostatic hyperplasia
Scientific Title
Study on the effect of combination therapy of alpha-1 blocker and transdermal oxybutynin hydrochloride in patients with overactive bladder due to benign prostatic hyperplasia
Scientific Title:Acronym
Study on the combination therapy of alpha-1 blocker and transdermal oxybutynin in patients with overactive bladder due to benign prostatic hyperplasia
Region
| Japan |
Condition
Condition
Patients with overactive bladder due to benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy of combination therapy of alpha-1 blocker and transdermal oxybutynin hydrochloride
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in total score of overactive bladder symptoms score(OABSS) 4weeks after the intervention
Key secondary outcomes
Change in each item of OABSS 4weeks after the intervention
Change in International Prostate Symptoms Score 4weeks after the intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Addition of transdermal oxybutynin hydrochloride 73.5mg once per day for 4weeks
Interventions/Control_2
Monotherapy of alpha-1 blocker
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
Patients with LUTS/BPH who have urgency score of OABSS 2 or more, and total score of OABSS 3 or more after taking alpha-1 blocker for 4 weeks or more
Key exclusion criteria
Qmax on uroflowmetry 5ml/sec or less, postvoid residual urine 100ml or more, patients who underwent radiation to the prostate
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Wada |
Organization
Asahikawa Medical University
Division name
Department of Renal and Urologic Surgery
Zip code
Address
2-1-1-1 Midorigaoka-Higashi, Asahikawa, Japan
TEL
0166-68-2533
nwada@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Wada |
Organization
Asahikawa Medical University
Division name
Department of Renal and Urologic Surgery
Zip code
Address
2-1-1-1 Midorigaoka-Higashi, Asahikawa, Japan
TEL
0166-68-2533
Homepage URL
nwada@asahikawa-med.ac.jp
Sponsor or person
Institute
Department of Renal and Urologic Surgery, Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Renal and Urologic Surgery, Asahikawa Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Inada urology clinic
Fukagawa City Hospital
Furano Hospital
Asahikawa-Kosei Hospital
Jinyukai urology clinic
Kitasaito Hospital
Ashibetsu City Hospital
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
| 2016 | Year | 04 | 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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 12 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 12 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 09 | Day |
Last modified on
| 2021 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024703
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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