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Reproducibility Study of Over Active Bladder Symptom Score [OABSS] (RESORT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00901251
First Posted: May 13, 2009
Last Update Posted: March 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma China, Inc.
Information provided by:
Astellas Pharma Inc
  Purpose
The purpose of this study is to evaluate the reproducibility of over active bladder symptom score (OABSS) in Asian countries.

Condition
Overactive Bladder

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Reproducibility Study of OABSS and Its Response to Treatment - Part 1: Reproducibility -

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • OABSS [ Time Frame: Weeks of 0 and 2 ]

Secondary Outcome Measures:
  • 3-day micturition diary [ Time Frame: 2 times in 2-week interval ]

Enrollment: 50
Study Start Date: January 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Symptomatic OAB patients having urgency episodes
Criteria

Inclusion Criteria:

  • Symptoms OAB for 3 months or longer
  • At least 1 urgency episode in last 3 days
  • Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:

    • Number of micturition ≥8 times/day
    • Number of urgency episode in 3 days ≥1

Exclusion Criteria:

  • Indwelling catheters or practicing intermittent self-catheterization
  • Symptomatic urinary tract infection, chronic inflammation
  • Diabetic neuropathy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901251


Locations
China
Beijing, China
Chongqing, China
Shanghai, China
Shenyang, China
Wuhan, China
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma China, Inc.
Investigators
Study Chair: Use Central Contact Astellas Pharma China, Inc.
  More Information

Responsible Party: Disclosure Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00901251     History of Changes
Other Study ID Numbers: VESOABCN02
First Submitted: May 11, 2009
First Posted: May 13, 2009
Last Update Posted: March 15, 2011
Last Verified: March 2011

Keywords provided by Astellas Pharma Inc:
OABSS

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms