UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038483 |
|---|---|
| Receipt number | R000043851 |
| Scientific Title | Add on Effect of Fesoterodine and Vibegron for Male Overactive Bladder Treated with Tadalafil Multicenter Randomized Comparative Study |
| Date of disclosure of the study information | 2019/12/31 |
| Last modified on | 2019/11/03 10:41:04 |
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Basic information
Public title
Add on Effect of Fesoterodine and Vibegron for Male Overactive Bladder Treated with Tadalafil Multicenter Randomized Comparative Study
Acronym
FAVORITE Study
Scientific Title
Add on Effect of Fesoterodine and Vibegron for Male Overactive Bladder Treated with Tadalafil Multicenter Randomized Comparative Study
Scientific Title:Acronym
FAVORITE Study
Region
| Japan |
Condition
Condition
overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of add-on therapy of anticholinergic or beta 3 adrenoceptor agonist with tadalafil for male OAB patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overactive bladder symptom score
Key secondary outcomes
IPSS and frequency volume chart
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Bivegron 50mg 12weeks
Interventions/Control_2
Fesoterodin 4mg 12weeks
Interventions/Control_3
No add-on treatment
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
Male OAB patients with over 8 weeks of tadalafil treatment
Key exclusion criteria
Over 100ml of postvoid residual
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Wada |
Organization
Asahikawa Medical University
Division name
Renal and Urologic Surgery
Zip code
0788510
Address
2-1Higashi Midorigaoka Asahikawa
TEL
0166-68-2533
nwada@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Wada |
Organization
Asahikawa Medical University
Division name
Renal and Urologic Surgery
Zip code
0788510
Address
2-1 Higashi Midorigaoka Asahikawa
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
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
Asahikawa Medical University
Address
2-1Higashi Midorigaoka Asahikawa
Tel
0166-66-1300
rs-kk.g@asahikawa-med.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 | 12 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 09 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 03 | Day |
Last modified on
| 2019 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043851
