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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038803
Receipt No. 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

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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
Email 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
Email rinri@gifu-u.ac.jp

Sponsor
Institute GIFU UNIVERSITY
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044241

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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