Clinical trial NCT01489709: Post Marketing Survey of Vesicare in Japan
Official title: Specified Drug Use Results Survey of Vesicare Tablets
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Keywords: overactive bladder
solifenacin
Overactive bladder questionnaire
Overactive Bladder Symptom Score
satisfaction score
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-12-12
Enrollment: 1160
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Changes in OAB-q (overactive bladder questionnaire)
timeFrame: Baseline and at 12 weeks (or last observation period)
Secondary outcomes:
measure: Changes in OABSS (overactive bladder symptom score)
timeFrame: Baseline and at 12 weeks (or last observation period)
measure: Changes in satisfaction score for urination
timeFrame: Baseline and at 12 weeks (or last observation period)
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
city: Shikoku
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References: