An observational study in Urinary Incontinence, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-06.
Sponsored by Riphah International University · Observational
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.
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 200 is above the median of 120 across 305 observational studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.
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Pakistani women suffering from urinary incontinence.
Exclusion Criteria:
Questionnaire for Urinary Incontinence Diagnosis
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
Time frame: 1st day
Pelvic Floor Distress Inventory
Pelvic Floor Distress Inventory consists of twenty questions which are divided into three subscales (Pelvic organ prolapse, intestine, and bladder portion)
Time frame: 1st day
Pelvic Floor Impact Questionnaire
Pelvic Floor Impact Questionnaire contains 7 questions with 3 domains (urinary, pelvic organ prolapse, and colon-rectal anal).
Time frame: 1st day
International Consultation on Incontinence Questionnaire-Short Form
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
Time frame: 1st day
Plan to share: No
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Riphah International University