Specified Drug Use-results Survey of Betanis Tablets

Specified Drug Use-results Survey of Betanis Tablets in OAB Patients With Coexisting Glaucoma

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01898624

Enrollment

300

Registered

2013-07-12

Start date

2012-12-04

Completion date

2018-01-10

Last updated

2018-02-05

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

Conditions

Overactive Bladder

Keywords

mirabegron, Overactive Bladder, Betanis®, glaucoma

Brief summary

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

Interventions

DRUGmirabegron

oral

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Japan

Outcome results

None listed

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