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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039150
Receipt No. R000044653
Scientific Title Clinical investigation of combination therapy with a1 blocker and vibegron for treating overactive bladder in patients with benign prostatic hyperplasia
Date of disclosure of the study information 2020/01/27
Last modified on 2020/01/30

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Basic information
Public title Clinical investigation of combination therapy with a1 blocker and vibegron for treating overactive bladder in patients with benign prostatic hyperplasia
Acronym Efficacy of combination therapy with a1 blocker and vibegron for treating overactive bladder in patients with benign prostatic hyperplasia
Scientific Title Clinical investigation of combination therapy with a1 blocker and vibegron for treating overactive bladder in patients with benign prostatic hyperplasia
Scientific Title:Acronym Efficacy of combination therapy with a1 blocker and vibegron for treating overactive bladder in 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 To evaluate the effect of combination therapy with a1 blocker and vibegron on overactive bladder and sexual function in patients with benign prostatic hyperplasia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of OABSS score after 8 weeks
Key secondary outcomes 1) The change of IIEF15 score after 8 weeks
2) The change of EHS score after 8 weeks
3) The change of IPSS score after 8 weeks
4) The level of serum free testosterone and CRP

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 vibegron 50mg daily in 8 weeks
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

Not applicable
Gender Male
Key inclusion criteria 1) Overactive bladder after treatment with a1 blocker in BPH patients
2) Total OABSS scores of 3 or more, urinary urgency episodes of 2 per week or more
3) Patients who have provided consent for participation.
Key exclusion criteria 1) Suspect of malignancy
2) Patient with allergy to beta 3 agonists
3) Patient using a1 blocker within 4 weeks
4) Patients whom investigators consider to be ineligible.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Akemi
Middle name
Last name Yamashita
Organization Koto Hospital
Division name Department of Urology
Zip code 1360072
Address 6-8-5, Ojima, Koto-ku, Tokyo, Japan
TEL 0336852166
Email akeyamasit@yahoo.co.jp

Public contact
Name of contact person
1st name Akemi
Middle name
Last name Yamashita
Organization Koto Hospital
Division name Department of Urology
Zip code 1360072
Address 6-8-5, Ojima, Koto-ku, Tokyo, Japan
TEL 0336852166
Homepage URL
Email akeyamasit@yahoo.co.jp

Sponsor
Institute Koto Hospital, Dept. of Urology
Institute
Department

Funding Source
Organization Koto Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Department of general affairs, Koto Hospital
Address 6-8-5, Ojima, Koto-ku, Tokyo, Japan
Tel 0336852166
Email soumu-s@koto-hospital.or.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
2020 Year 01 Month 27 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 Enrolling by invitation
Date of protocol fixation
2019 Year 12 Month 24 Day
Date of IRB
2019 Year 12 Month 26 Day
Anticipated trial start date
2019 Year 12 Month 26 Day
Last follow-up date
2020 Year 08 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 14 Day
Last modified on
2020 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044653

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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