An observational study in Cystitis Acute, sponsored by Al-Kindy College of Medicine. Recruiting at 2 sites in Iraq. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by Al-Kindy College of Medicine · Observational
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:
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.
69 studies on the registry are indexed under Cystitis; 17 are open to participants now.
This study's planned enrollment of 200 is close to the median of 216 across 15 observational studies indexed under Cystitis.
Browse Cystitis studies →Al-Kindy College of Medicine is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
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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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: 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.
Time frame: 7 months
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Al-Kindy College of Medicine