NCT01489709

Post Marketing Survey of Vesicare in Japan

Specified Drug Use Results Survey of Vesicare Tablets

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,160 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the effect of Vesicare on quality of life (QOL) in female patients.

Detailed description

Overactive bladder (OAB) represents a constellation of symptoms that must include urinary urgency as an essential symptom for the diagnosis. It is usually accompanied by daytime frequency and nighttime frequency (urgency incontinence is not an essential symptom) and impairs the patient's activities of daily living and quality of life (QOL). The objective of this survey is to confirm QOL improvement in patients treated with Vesicare (Generic Name: solifenacin succinate), with the use of OAB-q (Overactive bladder questionnaire), a questionnaire for assessment of OAB symptoms and QOL. The effect of improvement of OAB symptoms by solifenacin on QOL will also be confirmed. This survey will not include male OAB patients since many of them have benign prostatic hyperplasia as a coexisting disease and their QOL is supposed to be affected by α1-blocker treatment. To define patient's response to solifenacin in terms of QOL more clearly, this survey will include only female OAB patients.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	Vesicare	oral

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2011-12-12
• Last updated: 2014-09-05

Locations

8 sites across 1 country: Japan