Overactive BladderNCT04309890
Arabic Translation and Validation of the (Overactive Bladder Symptom Score) OABSS
An observational study of Overactive Bladder, run by Mutah University at 1 site in Jordan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Arabic version of the Overactive Bladder Symptom Score Questionnaire
- How many people
- 235 participants
- Where
- 1 siteJordan
- Study dates
- 1 Feb 2019to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study has included 235 patients, 152 (62.9%) females and 83 (37.1%) males.
Who may be able to join
- More than 20 years
- Had three months history of overactive bladder symptoms (urgency with or without incontinence and associated with frequency and nocturia).
Who cannot join
- Active urinary tract infection.
- Predominant symptoms of urinary stress incontinence;
- Diabetes mellitus;
- Previous abdominal and pelvic (urological or gynecological gastrointestinal) surgery;
- Previous neurological disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Overactive Bladder
- Being tested
- Arabic version of the Overactive Bladder Symptom Score Questionnaire
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arabic version of the Overactive Bladder Symptom Score QuestionnaireOther
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
| Study group | Role | What they receive |
|---|---|---|
| Study group | Not described Receives: Other: Arabic version of the Overactive Bladder Symptom Score Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
development and validation of Arabic version of the Overactive Bladder Symptom Score (OABSS) questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start1 Feb 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mutah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fadi Sawaqed, Mutah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309890
- Sponsor's protocol ID
- Arabic OABSS- 7 items
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 16 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sawaqed F, Suoub M. Validating 7-items Overactive Bladder Symptom Score (OABSS) through Arabic linguistic version. Sci Rep. 2021 Jan 12;11(1):661. doi: 10.1038/s41598-020-79974-9.
PubMed 33436744
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating 7-items Overactive Bladder Symptom Score (OABSS) Through Arabic Linguistic Version
- ClinicalTrials.gov ID
- NCT04309890
- Acronym / sponsor ID
- Arabic OABSS- 7 items
- Conditions
- Overactive Bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Mutah UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Arabic version of the Overactive Bladder Symptom Score Questionnaire |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study has included 235 patients, 152 (62.9%) females and 83 (37.1%) males.
Key inclusion criteria (2 listed)
- More than 20 years
- Had three months history of overactive bladder symptoms (urgency with or without incontinence and associated with frequency and nocturia).
Key exclusion criteria (5 listed)
- Active urinary tract infection.
- Predominant symptoms of urinary stress incontinence;
- Diabetes mellitus;
- Previous abdominal and pelvic (urological or gynecological gastrointestinal) surgery;
- Previous neurological disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arabic version of the Overactive Bladder Symptom Score QuestionnaireAll 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 | Other | Study group |
Primary outcome
development and validation of Arabic version of the Overactive Bladder Symptom Score (OABSS) questionnaire
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Derived from this study: PubMed 33436744Sawaqed F, Suoub M. Validating 7-items Overactive Bladder Symptom Score (OABSS) through Arabic linguistic version. Sci Rep. 2021 Jan 12;11(1):661. doi: 10.1038/s41598-020-79974-9.
- Individual participant dataSharing planned: Undecided
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Overactive Bladder (OAB)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder, run by Mutah University at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
development and validation of Arabic version of the Overactive Bladder Symptom Score (OABSS) questionnaire (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04309890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.