- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01122550
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
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Bandung, Indonesia
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Jakarta, Indonesia
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Surabaya, Indonesia
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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
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Weeks 0 and 2
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
International Prostate Symptom Score (IPSS)
Time Frame: Weeks 0 and 2
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Weeks 0 and 2
|
Quality of Life (QOL) score
Time Frame: Weeks 0 and 2
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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.
Sponsor
Collaborators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EQL-CRU.004-2009
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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