UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038803 |
|---|---|
| Receipt number | R000044241 |
| Scientific Title | Study of silodosin and Vibegron combination therapy for overactive bladder patients with benign prostatic hyperplasia. |
| Date of disclosure of the study information | 2019/12/06 |
| Last modified on | 2019/12/05 20:13:44 |
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Basic information
Public title
Study of silodosin and Vibegron combination therapy for overactive bladder patients with benign prostatic hyperplasia.
Acronym
Study of silodosin and Vibegron combination therapy for overactive bladder patients with benign prostatic hyperplasia.
Scientific Title
Study of silodosin and Vibegron combination therapy for overactive bladder patients with benign prostatic hyperplasia.
Scientific Title:Acronym
Study of silodosin and Vibegron combination therapy for overactive bladder patients with benign prostatic hyperplasia.
Region
| Japan |
Condition
Condition
overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of combination therapy of Silodosin and Vibegron (50mg / day) for patients with overactive bladder with benign prostatic hyperplasia who cannot achieve symptom relief with single-dose silodosin (8mg / day) for 4 weeks consider.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in overactive bladder symptoms questionnaire (OABSS) total score.
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
Take Vibegron (50mg / day) for 4week.
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
| 90 | years-old | > |
Gender
Male
Key inclusion criteria
1.Male patient diagnosed with BPH.
2.Patients receiving silodosin for 4 weeks at the time of registration.
3.Patients whose OABSS total score exceeds 3 points and urinary urgency exceeds 1 / week
(OABSS urgency score of 2 points or more).
4.Patients who are over 50 years old and under 90 years old when obtaining consent.
5.Patients who have obtained written consent for participation in this study.
Key exclusion criteria
1.Patients with a history of hypersensitivity to silodosin or Vibegron.
2.Patients who have started taking anticholinergic drugs, cholinergic drugs, beta3 agonists, beta antagonists, alpha-receptor blockers and other frequent urinary/urinary incontinence drugs within 8 weeks (excluding silodosin). In addition, a 5alpha-reductase inhibitor or an antiandrogen is administered 6months or more in advance and can be incorporated if the patient's condition is stable.
3.Patients with urinary retention or severe urination difficulty or patients with a history of urination.
4.Patients with neoplasms in the lower urinary tract such as bladder cancer and prostate cancer, neurogenic bladder, urethral stricture, chronic bacterial prostatitis, active urinary tract infection, urinary calculus, interstitial cystitis.
5.Patients who have more than 100mL of residual urine at the time of consent and registration.
6.Patients who are judged to be inappropriate as the subject of researcher.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | HIROKI |
| Middle name | |
| Last name | ITO |
Organization
GIFU UNIVERSITY HOSPITAL
Division name
urology
Zip code
501-1194
Address
1-1 Yanagido, Gifu City
TEL
058-230-6341
rinri@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | HIROKI |
| Middle name | |
| Last name | ITO |
Organization
GIFU UNIVERSITY HOSPITAL
Division name
urology
Zip code
501-1194
Address
1-1 Yanagido, Gifu City
TEL
058-230-6341
Homepage URL
rinri@gifu-u.ac.jp
Sponsor or person
Institute
GIFU UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
GIFU UNIVERSITY
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
Gifu University graduate school of medicine / school of medicine
Address
1-1 Yanagido, Gifu City
Tel
058-230-6059
rinri@gifu-u.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 | 06 | 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
| 2019 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | 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 | 12 | Month | 05 | Day |
Last modified on
| 2019 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044241
| Research Plan | |
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| 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 |
