Post Marketing Survey of Vesicare in Japan

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: Vesicare

• Registration Number: NCT01489709
• Lead Sponsor: Astellas Pharma Inc

Brief 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.

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2011-12-08
• Study First Submitted QC: 2011-12-08
• Study First Posted: 2011-12-12
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-04
• Last Update Posted: 2014-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1160

Inclusion Criteria

• Previously untreated OAB patients
• Patients who meet the diagnostic criteria for OAB provided in the clinical guidelines for overactive bladder (patients who have urinary urgency at least once weekly as an essential symptom and at least one of the other OAB symptoms including daytime frequency, nighttime frequency, and urgency incontinence)
• Patients who can understand and answer OAB-q (Japanese version)
• Patients from whom data on all items concerning OABSS, OAB-q, and satisfaction score for urination can be obtained at baseline
• Patients who are expected to be treated for at least 12 weeks

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vesicare group	Vesicare	Who receive vesicare

Primary Outcome Measures

Name	Time	Method
Changes in OAB-q (overactive bladder questionnaire)	Baseline and at 12 weeks (or last observation period)

Secondary Outcome Measures

Name	Time	Method
Changes in OABSS (overactive bladder symptom score)	Baseline and at 12 weeks (or last observation period)
Changes in satisfaction score for urination	Baseline and at 12 weeks (or last observation period)