Post Marketing Survey of Vesicare in Japan (SET-Q)

Astellas

Status: Completed

Conditions: Overactive Bladder

Treatments: Drug: Vesicare

Study type: Observational

Funder types: Industry

Identifiers

NCT01489709

905-JC-VC0004

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,160 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

1,160 participants in 1 patient group

Vesicare group

Description:

Who receive vesicare

Treatment:

Drug: Vesicare