Post Marketing Survey of Vesicare in Japan (SET-Q)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01489709
First received: December 8, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
  Purpose

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


Condition Intervention
Overactive Bladder
Drug: Vesicare

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specified Drug Use Results Survey of Vesicare Tablets

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Changes in OAB-q (overactive bladder questionnaire) [ Time Frame: Baseline and at 12 weeks (or last observation period) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1160
Study Start Date: June 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Vesicare group
Who receive vesicare
Drug: Vesicare
oral
Other Name: solifenacin

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489709

Locations
Japan
Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyushu, Japan
Shikoku, Japan
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01489709     History of Changes
Other Study ID Numbers: VC0004
Study First Received: December 8, 2011
Last Updated: December 8, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:
overactive bladder
solifenacin
Overactive bladder questionnaire
Overactive Bladder Symptom Score
satisfaction score

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014