UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039150
Receipt number 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 19:33:46

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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 or person

Institute

Koto Hospital, Dept. of Urology

Institute

Department

Personal name



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

Value
https://center6.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