Clinical trial NCT06267040: Linguistic and Clinical Validation of the Arabic Version of Acute Cystitis Symptom Score (ACCS)
Official title: Linguistic and Clinical Validation of the Arabic Version of Acute Cystitis Symptom Score (ACCS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cystitis Acute
Keywords: uncomplicated cystitis
linguistic validation
Acute Cystitis symptom score
ACSS
Lead sponsor: Al-Kindy College of Medicine
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women presented to the urology or gynecology and obstetrics outpatient clinics at Alkindy Teaching Hospital and Al-Elwiya Maternity Teaching Hospital having the diagnosis of uncomplicated cystitis will serve as the case group.

In addition, a control group of women attending the same clinics who are complaining of conditions unlikely to affect the symptoms of the lower urinary tract will be recruited as a control group

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Linguistic validity
timeFrame: 14 days
measure: Clinical reliability
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Al-Elwiya Maternity Teaching Hospital
city: Baghdad
country: Iraq
facility: Alkindy Teaching Hospital
Study officials:
affiliation: University of Baghdad / Alkindy College of Medicine
name: Harth Mohamed Kamber, FICMS (Uro.)
role: STUDY_CHAIR
affiliation: University of Baghdad / Alkindy College of Medicine
name: Zahraa Muhmmed Jameel Al-Sattam, FICMS (Gyn.)
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Baghdad / Alkindy College of Medicine
name: Weqar Akram Hussein, FICMS (Gyn.)
role: PRINCIPAL_INVESTIGATOR
affiliation: Dijlah University College
name: Ahmed Abed Marzook, FICMS
role: PRINCIPAL_INVESTIGATOR
References: