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

March 13, 2011 updated by: Astellas Pharma Inc

Reproducibility Study of OABSS and Its Response to Treatment - Part 1: Reproducibility -

The purpose of this study is to evaluate the reproducibility of over active bladder symptom score (OABSS) in Asian countries.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
      • Chongqing, China
      • Shanghai, China
      • Shenyang, China
      • Wuhan, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Symptomatic OAB patients having urgency episodes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
OABSS
Time Frame: Weeks of 0 and 2
Weeks of 0 and 2

Secondary Outcome Measures

Outcome Measure
Time Frame
3-day micturition diary
Time Frame: 2 times in 2-week interval
2 times in 2-week interval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma China, Inc.

Investigators

  • Study Chair: Use Central Contact, Astellas Pharma China, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

May 11, 2009

First Submitted That Met QC Criteria

May 12, 2009

First Posted (Estimate)

May 13, 2009

Study Record Updates

Last Update Posted (Estimate)

March 15, 2011

Last Update Submitted That Met QC Criteria

March 13, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VESOABCN02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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