- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05221034
Urdu Version of Questionnaire for Female Urinary Incontinence Diagnosis: Reliability and Validity Study
July 4, 2022 updated by: Riphah International University
Cross-Cultural Adaptation, Reliability, Validity, and Responsiveness of the Urdu Version of Questionnaire for Female Urinary Incontinence Diagnosis
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Punjab
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Faisalabad, Punjab, Pakistan, 38000
- Ripah International University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Pakistani women suffering from urinary incontinence.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionnaire for Urinary Incontinence Diagnosis
Time Frame: 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
|
1st day
|
Pelvic Floor Distress Inventory
Time Frame: 1st day
|
Pelvic Floor Distress Inventory consists of twenty questions which are divided into three subscales (Pelvic organ prolapse, intestine, and bladder portion)
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1st day
|
Pelvic Floor Impact Questionnaire
Time Frame: 1st day
|
Pelvic Floor Impact Questionnaire contains 7 questions with 3 domains (urinary, pelvic organ prolapse, and colon-rectal anal).
|
1st day
|
International Consultation on Incontinence Questionnaire-Short Form
Time Frame: 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
|
1st day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 30, 2021
Primary Completion (ACTUAL)
February 20, 2022
Study Completion (ACTUAL)
February 28, 2022
Study Registration Dates
First Submitted
February 1, 2022
First Submitted That Met QC Criteria
February 1, 2022
First Posted (ACTUAL)
February 2, 2022
Study Record Updates
Last Update Posted (ACTUAL)
July 6, 2022
Last Update Submitted That Met QC Criteria
July 4, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC-FSD-00283
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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