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

April 13, 2024 updated by: Al-Kindy College of Medicine

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iraq
      • Baghdad, Iraq, 10064
        • Recruiting
        • Al-Elwiya Maternity Teaching Hospital
        • Principal Investigator:
          • Zahraa Muhmmed Jameel Al-Sattam, FICMS (Gyn.)
        • Sub-Investigator:
          • Weqar Akram Hussein, FICMS (Gyn.)
      • Baghdad, Iraq, 10064
        • Recruiting
        • Alkindy Teaching Hospital
        • Contact:
        • Principal Investigator:
          • Harth Mohamed Kamber, FICMS (Uro.)
        • Sub-Investigator:
          • Ahmed Abed Marzook, FICMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days
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.
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Kindy College of Medicine

Investigators

  • Study Chair: Harth Mohamed Kamber, FICMS (Uro.), University of Baghdad / Alkindy College of Medicine
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

April 15, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 13, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17 Al-KindyCM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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