Post Marketing Survey of Vesicare in Japan (SET-Q)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Specified Drug Use Results Survey of Vesicare Tablets|
- Changes in OAB-q (overactive bladder questionnaire) [ Time Frame: Baseline and at 12 weeks (or last observation period) ] [ Designated as safety issue: No ]
- Changes in OABSS (overactive bladder symptom score) [ Time Frame: Baseline and at 12 weeks (or last observation period) ] [ Designated as safety issue: No ]
- Changes in satisfaction score for urination [ Time Frame: Baseline and at 12 weeks (or last observation period) ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Who receive vesicare
Other Name: solifenacin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489709
|Study Chair:||Use Central Contact||Astellas Pharma Inc|