An observational study in Overactive Bladder, sponsored by Astellas Pharma Inc. Completed at 8 sites in Japan. Open to female participants. Per ClinicalTrials.gov, last updated 2014-09-05.
Sponsored by Astellas Pharma Inc · Observational
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.
855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 1,160 is above the median of 109 across 166 observational studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
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)
Inclusion Criteria:
Who receive vesicare
Drug: Vesicare
oral
Also known as: solifenacin
Changes in OAB-q (overactive bladder questionnaire)
Time frame: Baseline and at 12 weeks (or last observation period)
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)
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Inc