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Linguistic and Clinical Validation of the Arabic Version of Acute Cystitis Symptom Score (ACCS)

Linguistic and Clinical Validation of the Arabic Version of Acute Cystitis Symptom Score (ACCS)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06267040
Enrollment
200
Registered
2024-02-20
Start date
2023-09-01
Completion date
2024-04-30
Last updated
2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystitis Acute

Keywords

uncomplicated cystitis, linguistic validation, Acute Cystitis symptom score, ACSS

Brief summary

The goal of this prospective observational study is to provide an Arabic translation of the Acute Cystitis Symptom Score (ACSS) and to test the linguistic validity and clinical reliability of the translated Arabic version of ACCS (Arabic-ACCS) in Arabic-speaking women older than 18 years of age diagnosed with uncomplicated cystitis. The main questions it aims to answer are: * Do the questions of the Arabic-ACSS have sufficient clarity? * Can the Arabic-ACCS serve its purpose in identifying the presence of uncomplicated cystitis in Arabic-speaking women? The participant will be asked to fill out the Arabic-ACCS questionnaire at the time of diagnosis. The participants will be asked to fill out the second part of the Arabic-ACCS questionnaire 5-10 days later after receiving the appropriate treatment according to the local health policy as prescribed by the treating physician. Researchers will compare the results from the patients who filled out the first part of the questionnaire with the results of a comparable group of women who were presented with complaints unrelated to the lower urinary tract.

Interventions

None listed

Sponsors

Al-Kindy College of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

Inclusion criteria

* women. * presented to the urology or gynecology and obstetrics outpatient clinics. * having the diagnosis of uncomplicated cystitis.

Exclusion criteria

* pregnancy. * urethral catheterization. * anatomical abnormality of the urinary tract. * Neurologic abnormality that affects bladder function. * urinary tract stones. * recent antibiotic usage (within 1 month). * immunosuppression.

Design outcomes

Primary

MeasureTime frameDescription
Linguistic validity14 daysEach question in the translated Arabic version of the Acute Cystitis Symptom Score questionnaire should be clear, and the answer to the question should provide the desired piece of information. The acute cystitis symptom score questionnaire consists of four domains at the first visit. These domains ask about typical symptoms (6 questions), differential symptoms (4 questions), quality of life (3 questions), and additional information (5 questions). In addition to the aforementioned items, there is a dynamic domain (one question) that is only asked on the second visit.
Clinical reliability7 monthsThe linguistically validated, translated Arabic version of the Acute Cystitis Symptom Score questionnaire should be able to recognize patients with acceptable specificity and sensitivity. The sum of the typical symptoms, deferential symptoms, and quality of life domain scores can range from 0 to 18, 0 to 12, and 0 to 9, respectively. The lower score signifies less severity; the top score is the most severe grade for each domain. The additional domain consists of five yes or no questions designed to discover if there are any criteria that may exclude the diagnosis of uncomplicated cystitis or produce similar symptoms. The sum of the typical symptoms domain alone will be tested for its diagnostic reliability. In addition, the sum of both typical symptoms and quality of life domains is also to be tested for its diagnostic reliability.

Countries

Iraq

Contacts

Primary ContactHarth Mohamed Kamber, FICMS (Uro.)
harthkamber@kmc.uobaghdad.edu.iq+9647706029071

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026