Reproducibility Study of Overactive Bladder Symptom Score [OABSS] (RESORT-1)

August 23, 2010 updated by: Astellas Pharma Inc

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

The purpose of this study is to evaluate its reproducibility of overactive bladder symptom score (OABSS) and to evaluate its correlation to other measures of OAB symptoms.

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

      • Bandung, Indonesia
      • Jakarta, Indonesia
      • Surabaya, Indonesia

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 3-day micturition diary prior to Visit 1, defined by:

    • Number of micturition per day ≥8
    • Number of urgency episodes in 3 days ≥1

Exclusion Criteria:

  • Significant stress incontinence or mixed stress/urge incontinence
  • Subjects with indwelling catheters or practicing intermittent self-catheterization
  • Symptomatic urinary tract infection, chronic inflammation
  • Diabetic neuropathy
  • Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks
  • Participation in any clinical trial in 30 days

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
International Prostate Symptom Score (IPSS)
Time Frame: Weeks 0 and 2
Weeks 0 and 2
Quality of Life (QOL) score
Time Frame: Weeks 0 and 2
Weeks 0 and 2
Patient Perception of Bladder Condition (PPBC)
Time Frame: Weeks 0 and 2
Weeks 0 and 2

Collaborators and Investigators

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

Investigators

  • Study Chair: Use Central Contact, Astellas Pharma Indonesia

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

September 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

May 11, 2010

First Submitted That Met QC Criteria

May 11, 2010

First Posted (Estimate)

May 13, 2010

Study Record Updates

Last Update Posted (Estimate)

August 24, 2010

Last Update Submitted That Met QC Criteria

August 23, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

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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