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

Completed

• Conditions: Urinary Incontinence

• Registration Number: NCT05221034
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Study Start: 2021-05-30
• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-02
• Primary Completion: 2022-02-20
• Study Completion: 2022-02-28
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-04
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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?"

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pelvic Floor Distress Inventory	1st day	Pelvic Floor Distress Inventory consists of twenty questions which are divided into three subscales (Pelvic organ prolapse, intestine, and bladder portion)
Questionnaire for Urinary Incontinence Diagnosis	1st day	Questionnaire for Urinary Incontinence Diagnosis is a 6-item tool and its main purpose is to diagnose the two major kinds of urinary incontinence which are stress urinary incontinence and urge urinary incontinence. The first three questions of questions for Urinary Incontinence Diagnosis are related to stress and the next three are related to urge type. By totaling the response of each item the score of each domain is calculated and separated for both Stress Urinary Incontinence and Urgency Urinary Incontinence with the score of each ranging from 0 to 15. The cutoff value for Stress Urinary Incontinence is equal to or greater than 4 and the cutoff value for Urgency Urinary Incontinence is equal to or greater than 6
Pelvic Floor Impact Questionnaire	1st day	Pelvic Floor Impact Questionnaire contains 7 questions with 3 domains (urinary, pelvic organ prolapse, and colon-rectal anal).
International Consultation on Incontinence Questionnaire-Short Form	1st day	International Consultation on Incontinence Questionnaire-Short Form is a valid tool to assess the severity and impact of urine incontinence on the quality of life in females. The International Consultation on Incontinence Questionnaire-Short Form is a six-item tool out of which four major items are asked for the symptoms of urinary incontinence that happen in the previous four weeks. Item 1 and 2 are the demographics whereas items 3,4,5 are asked for the actual score of urinary incontinence. item 6 is a self-analytical question for urinary incontinence type

Trial Locations

Locations (1)

Ripah International University; 🇵🇰 Faisalabad, Punjab, Pakistan