Post Marketing Survey of Vesicare in Japan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-04-30

Brief Summary

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

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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.

Conditions

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Overactive Bladder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vesicare group

Who receive vesicare

Vesicare

Intervention Type DRUG

oral

Interventions

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Vesicare

oral

Intervention Type DRUG

Other Intervention Names

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solifenacin

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No