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

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: Betanis

• Registration Number: NCT01901120
• Lead Sponsor: Astellas Pharma Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2013-07-15
• Study First Posted: 2013-07-17
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-30
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1263

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Betanis	Betanis	the usual adult dosage of mirabegron once daily after a meal

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events	Up to 36 months after treatment

Secondary Outcome Measures

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