Sponsor study identifier
observational
200
1 country
2
Study Start
September 1, 2023
Actual (reported)Primary Completion
April 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2023
Actual (reported)February 12, 2024
Actual (reported)February 20, 2024
Actual (reported)April 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
women older than 18 years diagnosed with uncomplicated cystitis and treated accordingly
women older than 18 years presented for reasons unlikely to affect the lower urinary tract
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
Al-Elwiya Maternity Teaching Hospital
Baghdad, 10064, Iraq
Alkindy Teaching Hospital
Baghdad, 10064, Iraq
Harth Mohamed Kamber, FICMS (Uro.)
University of Baghdad / Alkindy College of Medicine
Zahraa Muhmmed Jameel Al-Sattam, FICMS (Gyn.)
University of Baghdad / Alkindy College of Medicine
Weqar Akram Hussein, FICMS (Gyn.)
University of Baghdad / Alkindy College of Medicine
Ahmed Abed Marzook, FICMS
Dijlah University College
First Submitted
February 12, 2024
First Posted
February 20, 2024
Study Start
September 1, 2023
Actual (reported)Primary Completion
April 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
April 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 16, 2024
Record last verified: 2024-01
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Source: ClinicalTrials.gov.
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