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

NCT06267040 | Unknown

• 1 other identifier: 17 Al-KindyCM
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Cystitis Acute

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Linguistic validity

  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.

  14 days

• Clinical reliability

  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.

  7 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Kindy College of Medicine: lead

Study Sites (2)

Al-Elwiya Maternity Teaching Hospital

Baghdad, 10064, Iraq

RECRUITING

Alkindy Teaching Hospital

Baghdad, 10064, Iraq

RECRUITING

Study Officials

• Harth Mohamed Kamber, FICMS (Uro.)

  University of Baghdad / Alkindy College of Medicine

  STUDY CHAIR

• Zahraa Muhmmed Jameel Al-Sattam, FICMS (Gyn.)

  University of Baghdad / Alkindy College of Medicine

  PRINCIPAL INVESTIGATOR

• Weqar Akram Hussein, FICMS (Gyn.)

  University of Baghdad / Alkindy College of Medicine

  PRINCIPAL INVESTIGATOR

• Ahmed Abed Marzook, FICMS

  Dijlah University College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harth Mohamed Kamber, FICMS (Uro.)

CONTACT

+9647706029071; harthkamber@kmc.uobaghdad.edu.iq

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: September 1, 2023
• Primary Completion: April 15, 2024
• Study Completion: April 30, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-01

Locations

IR (2)