Post Marketing Survey of Vesicare in Japan

Overactive Bladder Clinical Trial

— SET-Q  

Official title:

Specified Drug Use Results Survey of Vesicare Tablets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01489709
• Other study ID #: 905-JC-VC0004
• Status: Completed
• Phase: N/A
• First received: December 8, 2011
• Last updated: September 4, 2014
• Start date: June 2010
• Est. completion date: April 2011

Study information

• Verified date: September 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1160
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Vesicare
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in OAB-q (overactive bladder questionnaire)		Baseline and at 12 weeks (or last observation period)	No
Secondary	Changes in OABSS (overactive bladder symptom score)		Baseline and at 12 weeks (or last observation period)	No
Secondary	Changes in satisfaction score for urination		Baseline and at 12 weeks (or last observation period)	No

External Links

•   Link to Results on JAPIC - enter 140558 in the JapicCTI-RNo. field