UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000037233
Receipt No. R000042453
Scientific Title Effectiveness and Safety of Vibegron in Patients with Overactive Bladder: A Retrospective Chart Review of Patient Outcomes
Date of disclosure of the study information 2019/07/02
Last modified on 2019/11/28 (Ver. 7)

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Basic information
Public title Effectiveness and Safety of Vibegron in Patients with Overactive Bladder:
A Retrospective Chart Review of Patient Outcomes
Acronym Effectiveness and Safety of Vibegron in Patients with Overactive Bladder:
A Retrospective Chart Review of Patient Outcomes
Scientific Title Effectiveness and Safety of Vibegron in Patients with Overactive Bladder:
A Retrospective Chart Review of Patient Outcomes
Scientific Title:Acronym Effectiveness and Safety of Vibegron in Patients with Overactive Bladder:
A Retrospective Chart Review of Patient Outcomes
Region
Japan

Condition
Condition overactive bladder
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness and safety of vibegron in patients with overactive bladder (OAB) under the real-world clinical setting.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change in Overactive Bladder Symptom Score (OABSS) total score from baseline to 4 weeks
Key secondary outcomes 1) Change in OABSS sub-scores (4 elements) from baseline
2) Change in International Prostate Symptom Score (IPSS) total score from baseline
3) Change in IPSS sub-scores (3 and 7 elements) from baseline
4) Change in IPSS-QOL score from baseline
5) Proportion of subjects with minimum changes in OABSS total score
6) Individual scores of King's Health Questionnaire (KHQ)
7) Subgroup analyses for OABSS, IPSS, IPSS-QOL, and KHQ

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients over 20 years who met the all following criteria;
1) Patients who treated with vibegron over 4 weeks for OAB during November, 2018 to June, 2019.
2) Patients who collected OABSS at the start of vibegron and 4 weeks later.
Key exclusion criteria Nothing
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yoshinori
Middle name
Last name Nishino
Organization Nishino Clinic, Koseikai Medical Corp.
Division name director
Zip code 504-0941
Address 1-55-2, Miicho, Kakamigahara-shi, Gifu-Ken, 504-0941, Japan
TEL 058-371-0500
Email nishinoclinic-gifu@peace.ocn.ne.jp

Public contact
Name of contact person
1st name Rirei
Middle name
Last name Araiya
Organization Mebix, Inc.
Division name Clinical Research Division
Zip code 107-0052
Address Akasaka Intercity, 1-11-44 Akasaka, Minato-ku, Tokyo, 107-0052, Japan
TEL 03-4362-4504
Homepage URL
Email vibegron-retro@mebix.co.jp

Sponsor
Institute Nishino Clinic, Koseikai Medical Corp.
Institute
Department

Funding Source
Organization KISSEI PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Adachi Kyosai Hospital Institutional Review Board
Address 1-36-8, Yanagihara, Adachi Ku, Tokyo, 120-0022, Japan
Tel 03-3881-6116
Email hashimoto.emiko@e-smo.co.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 医療法人好誠会西野クリニック

Other administrative information
Date of disclosure of the study information
2019 Year 07 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 100
Results 
We have evaluated the effects of vibegron on OAB. A total of 100 patients who had been administered vibegron once a day for at least 4 weeks between November 2018 and June 2019 were analyzed. The primary endpoint for effectiveness was the change in OABSS between baseline and four weeks. Four weeks after treatment, total OABSS score was significantly improved. No new safety concerns were identified.
Results date posted
2019 Year 11 Month 28 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 11 Month 26 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2019 Year 06 Month 17 Day
Date of IRB
2019 Year 06 Month 27 Day
Anticipated trial start date
2019 Year 07 Month 02 Day
Last follow-up date
2019 Year 07 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective Chart Review

Management information
Registered date
2019 Year 07 Month 02 Day
Last modified on
2019 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042453