Post Marketing Survey of Vesicare in Japan

Astellas Pharma Inc1,160 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

1,160

Conditions

Overactive Bladder

Interventions

VesicareDRUG

oral

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (8)

Unnamed facility

Chugoku, Japan

Unnamed facility

Chūbu, Japan

Unnamed facility

Hokkaido, Japan

Unnamed facility

Kansai, Japan

Unnamed facility

Kantou, Japan

Outcomes

Primary Outcomes

Changes in OAB-q (overactive bladder questionnaire)

Time frame: Baseline and at 12 weeks (or last observation period)

Secondary Outcomes

Changes in OABSS (overactive bladder symptom score)

Time frame: Baseline and at 12 weeks (or last observation period)

Changes in satisfaction score for urination

Time frame: Baseline and at 12 weeks (or last observation period)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.