- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04309890
Arabic Translation and Validation of the (Overactive Bladder Symptom Score) OABSS
March 13, 2020 updated by: Fadi Sawaqed, Mutah University
Validating 7-items Overactive Bladder Symptom Score (OABSS) Through Arabic Linguistic Version
The English version of the Overactive Bladder Symptom Score (OABSS) questionnaire was translated to Arabic language.
The questionnaire was validated by comparing the response to the questionnaire in a patient with Overactive Bladder (OAB) before and after providing treatment with antimuscarinics.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
235
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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Karak, Jordan
- Mu'tah University
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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
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study has included 235 patients, 152 (62.9%) females and 83 (37.1%) males.
Description
Inclusion Criteria:
- More than 20 years
- Had three months history of overactive bladder symptoms (urgency with or without incontinence and associated with frequency and nocturia).
Exclusion Criteria:
- Active urinary tract infection.
- Predominant symptoms of urinary stress incontinence;
- Diabetes mellitus;
- Previous abdominal and pelvic (urological or gynecological gastrointestinal) surgery;
- Previous neurological disease.
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 |
Intervention / Treatment |
|---|---|
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Study group
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All enrolled patients were asked to complete the Arabic OABSS questionnaire in its final edition before and three months after treatment with Solfinasin 5 mg once daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
development and validation of Arabic version of the Overactive Bladder Symptom Score (OABSS) questionnaire
Time Frame: 3 months
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3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (ACTUAL)
February 1, 2019
Primary Completion (ACTUAL)
June 30, 2019
Study Completion (ACTUAL)
June 30, 2019
Study Registration Dates
First Submitted
March 13, 2020
First Submitted That Met QC Criteria
March 13, 2020
First Posted (ACTUAL)
March 16, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 16, 2020
Last Update Submitted That Met QC Criteria
March 13, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Arabic OABSS- 7 items
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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