Post Marketing Survey of Vesicare in Japan

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

Detailed Description
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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.

Official Title
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Specified Drug Use Results Survey of Vesicare Tablets

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Vesicare


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vesicare group<br>Who receive vesicare | Drug: Vesicare<br>* oral<br>* Other names: solifenacin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in OAB-q (overactive bladder questionnaire) |  | Baseline and at 12 weeks (or last observation period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overactive bladder, solifenacin, Overactive bladder questionnaire, Overactive Bladder Symptom Score, satisfaction score