Cystitis AcuteNCT06267040
Linguistic and Clinical Validation of the Arabic Version of Acute Cystitis Symptom Score (ACCS)
An observational study of Cystitis Acute, run by Al-Kindy College of Medicine at 2 sites in Iraq.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cystitis Acute
- How many people
- 200 participants
- Where
- 2 sitesIraq
- Study dates
- 1 Sep 2023to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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
Who may be able to join
- women.
- presented to the urology or gynecology and obstetrics outpatient clinics.
- having the diagnosis of uncomplicated cystitis.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Iraq2 sites, 2 recruiting
- Recruiting
Al-Elwiya Maternity Teaching Hospital
Baghdad, 10064
Zahraa Muhmmed Jameel Al-Sattam, FICMS (Gyn.)
Weqar Akram Hussein, FICMS (Gyn.)
- Recruiting
Alkindy Teaching Hospital
Baghdad, 10064
Harth Mohamed Kamber, FICMS (Uro.), +9647706029071, harthkamber@kmc.uobaghdad.edu.iq
Harth Mohamed Kamber, FICMS (Uro.)
About this study
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:
Read more
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Sep 2023
- Primary completion15 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystitis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Kindy College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harth Mohamed Kamber, FICMS (Uro.), Study chair, University of Baghdad / Alkindy College of MedicineZahraa Muhmmed Jameel Al-Sattam, FICMS (Gyn.), Principal investigator, University of Baghdad / Alkindy College of MedicineWeqar Akram Hussein, FICMS (Gyn.), Principal investigator, University of Baghdad / Alkindy College of MedicineAhmed Abed Marzook, FICMS, Principal investigator, Dijlah University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267040
- Sponsor's protocol ID
- 17 Al-KindyCM
- Status last verified
- Jan 2024
- First submitted
- 12 Feb 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linguistic and Clinical Validation of the Arabic Version of Acute Cystitis Symptom Score (ACCS)
- ClinicalTrials.gov ID
- NCT06267040
- Acronym / sponsor ID
- 17 Al-KindyCM
- Conditions
- Cystitis Acute
- Keywords
- uncomplicated cystitis, linguistic validation, Acute Cystitis symptom score, ACSS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Al-Kindy College of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- women.
- presented to the urology or gynecology and obstetrics outpatient clinics.
- having the diagnosis of uncomplicated cystitis.
Key exclusion criteria (7 listed)
- pregnancy.
- urethral catheterization.
- anatomical abnormality of the urinary tract.
- Neurologic abnormality that affects bladder function.
- urinary tract stones.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Linguistic validity
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystitis Acute, run by Al-Kindy College of Medicine at 2 sites in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harth Mohamed Kamber, FICMS (Uro.) (+9647706029071, harthkamber@kmc.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linguistic validity (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.