Specified Drug Use-results Survey of Betanis Tablets

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

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Key information

Conditions

Overactive Bladder Eye Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glaucoma Lower Urinary Tract Symptoms Male Urogenital Diseases Ocular Hypertension Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Sex eligibility

All sexes

Study type

Observational

Primary location

Chugoku, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mirabegron

Drug

oral

Other names: Betanis, YM178

Primary outcomes

The occurrence of ocular adverse events such as increased intraocular pressure and worsening of glaucoma

Time frame: 12 weeks

Secondary outcomes

Changes in OABSS (Over Active Bladder Symptoms Score)

Time frame: Baseline and 12 weeks of treatment

OABSS is judged by investigator

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2018
Study completion: 2018
First posted: Jul 12, 2013
Registry last updated: Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed