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

NCT ID: NCT05221034

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-30
• Study Completion Date: 2022-02-28

Brief 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

Urinary Incontinence

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Women age 18 years or above.
• Women who answered 'yes' to one or both of the following questions: "In the last month have your urine leaked involuntarily when you lifted weights, exercised, sneezed or coughed?" and "In the last month, have you sensed very strong urge to urinate, leaking urine before getting into the bathroom?"

Exclusion Criteria

• Current pregnancy or 3 months postpartum
• Any neurological disease
• Urinary tract infection, urogenital cancer, interstitial cystitis
• Taking treatment for PFD in the last 3 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad Kashif

Role: STUDY_CHAIR

Riphah International University

Locations

Ripah International University

Faisalabad, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

REC-FSD-00283

Identifier Type: -

Identifier Source: org_study_id