Clinical trial NCT05221034: Urdu Version of Questionnaire for Female Urinary Incontinence Diagnosis: Reliability and Validity Study
Official title: Cross-Cultural Adaptation, Reliability, Validity, and Responsiveness of the Urdu Version of Questionnaire for Female Urinary Incontinence Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Keywords: Urinary Incontinence
Questionnaire for female Urinary Incontinence Diagnosis
Cultural adaptation
Validity
Urdu Version
Reliability
Pelvic Floor Distress Inventory
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pakistani women suffering from urinary incontinence.

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.

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

Primary outcomes:
measure: Questionnaire for Urinary Incontinence Diagnosis
timeFrame: 1st day
measure: Pelvic Floor Distress Inventory
timeFrame: 1st day
measure: Pelvic Floor Impact Questionnaire
timeFrame: 1st day
measure: International Consultation on Incontinence Questionnaire-Short Form
timeFrame: 1st day
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References: