Specified Drug Use-results Survey of Betanis Tablets

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: mirabegron

• Registration Number: NCT01898624
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

To investigate the effects of mirabegron on the symptoms of glaucoma in overactive bladder (OAB) patients with coexisting glaucoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-04
• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2013-07-10
• Study First Posted: 2013-07-12
• Primary Completion: 2018-01-10
• Study Completion: 2018-01-10
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-01
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• diagnosed as OAB and treated with mirabegron
• diagnosed as glaucoma (including normal tension glaucoma)
• having intraocular pressure measurement conducted more than twice within six months before the start of the mirabegron treatment

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Betanis group	mirabegron	mirabegron treated group

Primary Outcome Measures

Name	Time	Method
The occurrence of ocular adverse events such as increased intraocular pressure and worsening of glaucoma	12 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in OABSS (Over Active Bladder Symptoms Score)	Baseline and 12 weeks of treatment	OABSS is judged by investigator