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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma China, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00901251
First received: May 11, 2009
Last updated: March 13, 2011
Last verified: March 2011
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 3-day micturition diary [ Time Frame: 2 times in 2-week interval ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Disclosure Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00901251     History of Changes
Other Study ID Numbers: VESOABCN02
Study First Received: May 11, 2009
Last Updated: March 13, 2011
Health Authority: China: Ministry of Health

Keywords provided by Astellas Pharma Inc:
OABSS

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

ClinicalTrials.gov processed this record on April 17, 2014