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

NCT06267040 — Unknown, 200 participants, Al-Kindy College of Medicine

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Registry	NCT06267040
Status	Unknown
Study type	Observational
Enrollment	200 (Estimated)
Sponsor	Al-Kindy College of Medicine (Other)
Conditions	Cystitis Acute
Dates	start 2023-09-01, primary completion 2024-04-15 (estimated), completion 2024-04-30 (estimated), first posted 2024-02-20, last updated 2024-04-16
Locations	2 sites in Iraq

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
women diagnosed with uncomplicated cystitis			women older than 18 years diagnosed with uncomplicated cystitis and treated accordingly
control group			women older than 18 years presented for reasons unlikely to affect the lower urinary tract

+Outcome measures

Primary outcomes

Linguistic validity [14 days]: Each 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 reliability [7 months]: The 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.

+Eligibility

Sex: Female, ages: 18 Years to any

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.

+Locations (2)

Facility	City	Country	Status
Al-Elwiya Maternity Teaching Hospital	Baghdad	Iraq	Recruiting
Alkindy Teaching Hospital	Baghdad	Iraq	Recruiting

+Investigators

Harth Mohamed Kamber, FICMS (Uro.), Study chair, University of Baghdad / Alkindy College of Medicine
Zahraa Muhmmed Jameel Al-Sattam, FICMS (Gyn.), Principal investigator, University of Baghdad / Alkindy College of Medicine
Weqar Akram Hussein, FICMS (Gyn.), Principal investigator, University of Baghdad / Alkindy College of Medicine
Ahmed Abed Marzook, FICMS, Principal investigator, Dijlah University College