Long-Term Specified Drug Use-results Survey of Betanis Tablets

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01901120

Enrollment

1263

Registered

2013-07-17

Start date

2012-10-31

Completion date

2016-09-30

Last updated

2016-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Keywords

Betanis®, mirabegron, Overactive Bladder

Brief summary

This study is to evaluate the safety and efficacy of long-term use of Betanis (generic name: mirabegron), and to determine the adherence to treatment with mirabegron.

Interventions

DRUGBetanis

oral

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients who administer mirabegron for treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder and also who have no treatment history of mirabegron.

Design outcomes

Primary

Measure	Time frame
Occurrence of adverse events	Up to 36 months after treatment

Secondary

Measure	Time frame
Overactive Bladder Symptom Score (OABSS)	At the start of treatment and 3, 6, 12, 18, 24, 30, and 36 months after treatment

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026