UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026394 |
|---|---|
| Receipt number | R000030328 |
| Scientific Title | Comparison in the efficacy of the two add on therapies with an anticholinergic agent versus a beta3-adrenoceptor agonist for patients with benign prostatic enlargement complicated by overactive bladder after alpha1-blocker administration, A randomized, prospective trial using a urodynamic study |
| Date of disclosure of the study information | 2017/03/10 |
| Last modified on | 2020/12/24 16:15:51 |
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Basic information
Public title
Comparison in the efficacy of the two add on therapies with an anticholinergic agent versus a beta3-adrenoceptor agonist for patients with benign prostatic enlargement complicated by overactive bladder after alpha1-blocker administration, A randomized, prospective trial using a urodynamic study
Acronym
Comparison in the efficacy of the two add on therapies with an anticholinergic agent versus a beta3-adrenoceptor agonist for BPH/OAB
Scientific Title
Comparison in the efficacy of the two add on therapies with an anticholinergic agent versus a beta3-adrenoceptor agonist for patients with benign prostatic enlargement complicated by overactive bladder after alpha1-blocker administration, A randomized, prospective trial using a urodynamic study
Scientific Title:Acronym
Comparison in the efficacy of the two add on therapies with an anticholinergic agent versus a beta3-adrenoceptor agonist for BPH/OAB
Region
| Japan |
Condition
Condition
benign prostatic enlargement complicated by overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate in the efficacy of the two add on therapies with fesoterodine versus a mirabegron for patients with benign prostatic enlargement complicated by overactive bladder after alpah1-blocker administration using a urodynamic study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
the change of storage and voiding function between the two add on therapies after 12 weeks' treatment
Key secondary outcomes
the change of subjective symptoms regarding lower urinary tract symptoms between the two add on therapies after 12 weeks' treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The administration of fesoterodine
Interventions/Control_2
The administration of mirabegron
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
| 90 | years-old | >= |
Gender
Male
Key inclusion criteria
1) patinets who have taken alpha-1 blocker for more than 12 weeks
2) total OAB symptom scores (OABSS) more than 2 and urinary urgency episodes more than 1 per week
3) outpatinets more than 50 years old
Key exclusion criteria
Patients were excluded if they received oral treatment with propafenone hydrochloride, flecainide acetate, anticholinergic agents, antidepressants, anti-anxiety agents, or sex hormonal agents; had neurogenic bladder dysfunction, bladder calculi, or active urinary tract infection; and had severe cardiac disease, renal dysfunction (serum creatinine level more than 2 mg/dL), and hepatic dysfunction (aspartate and alanine aminotransferase concentrations more than twice the normal values).
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Matsukawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
65 tsurumai, showa-ku, Nagoya, JAPAN
TEL
052-744-2985
yoshi44@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Matsukawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Urology
Zip code
Address
65 tsurumai, showa-ku, Nagoya, JAPAN
TEL
052-744-2985
Homepage URL
yoshi44@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
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
| 2017 | Year | 03 | Month | 10 | 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
| 2017 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 20 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 04 | Day |
Last modified on
| 2020 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030328
