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
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: 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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 15, 2014