Clinical Trials Directory

Trials / Completed

CompletedNCT05221034

Urdu Version of Questionnaire for Female Urinary Incontinence Diagnosis: Reliability and Validity Study

Cross-Cultural Adaptation, Reliability, Validity, and Responsiveness of the Urdu Version of Questionnaire for Female Urinary Incontinence Diagnosis

Status
Completed
Phase
Study type
Observational
Enrollment
200 (actual)
Sponsor
Riphah International University · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

The main objective of this study will be to translate and culturally adapt Questionnaire for Female Urinary Incontinence Diagnosis into the Urdu language and to evaluate its reliability and validity in the Pakistani urinary incontinence population. Also assess its correlation with Pelvic Floor Impact Questionnaire, Pelvic Floor Distress Inventory, International Consultation on Incontinence Questionnaire-short form for severity and also check the quality of life.

Detailed description

According to the previous recommendation, Questionnaire for Female Urinary Incontinence Diagnosis will be translated into the Urdu language from its original English version and adapted culturally in Pakistan. Amongst the urinary incontinence population, Questionnaire for Female Urinary Incontinence Diagnosis will be distributed in 200 patients who would be recruited by a convenience sampling technique under the pre-defined inclusion and exclusion criteria after signing the informed consent forms. To test the inter-observer reliability and intra-observer reliability of the Pelvic Floor Impact Questionnaire, Pelvic Floor Distress Inventory, International Consultation on Incontinence Questionnaire-short form questionnaires will be completed by two observers, on the same day, with a time interval of 2 hours between first and second distribution. For the 3rd assessment, questionnaires will be completed after 7 days by the first observer, for intra-observer assessment. Statistical Package of Social Sciences software version 24 will be used for the purpose of data entry and analysis. Internal consistency will be analyzed by Cronbach alpha value. Test-retest reliability will be assessed by using an intra-class correlation coefficient. The Questionnaire for Female Urinary Incontinence Diagnosis will be evaluated for content validity, construct validity, criterion validity, and responsiveness.

Conditions

Timeline

Start date
2021-05-30
Primary completion
2022-02-20
Completion
2022-02-28
First posted
2022-02-02
Last updated
2022-07-06

Locations

1 site across 1 country: Pakistan

Source: ClinicalTrials.gov record NCT05221034. Inclusion in this directory is not an endorsement.