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OpenTrials
Completed

NCT Number: NCT01489709

Post Marketing Survey of Vesicare in Japan

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vesicare

Drug

oral

Other names: solifenacin

Primary outcomes

  1. Changes in OAB-q (overactive bladder questionnaire)

    Time frame: Baseline and at 12 weeks (or last observation period)

Secondary outcomes

  1. Changes in OABSS (overactive bladder symptom score)

    Time frame: Baseline and at 12 weeks (or last observation period)

  2. Changes in satisfaction score for urination

    Time frame: Baseline and at 12 weeks (or last observation period)

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Specified Drug Use Results Survey of Vesicare Tablets

Acronym: SET-Q

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 12, 2011
Registry last updated
Sep 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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