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

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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases 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

Chūbu, Chubu, Japan

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Betanis

Drug

oral

Other names: YM178, mirabegron

Primary outcomes

Occurrence of adverse events

Time frame: Up to 36 months after treatment

Secondary outcomes

Overactive Bladder Symptom Score (OABSS)

Time frame: At the start of treatment and 3, 6, 12, 18, 24, 30, and 36 months after treatment

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Jul 17, 2013
Registry last updated: Nov 1, 2016

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