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

NCT05221034 | Completed DMC

• 1 other identifier: REC-FSD-00283
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

Urinary Incontinence; Questionnaire for female Urinary Incontinence Diagnosis; Cultural adaptation; Validity; Urdu Version; Reliability; Pelvic Floor Distress Inventory

Outcome Measures

Primary Outcomes (4)

• 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

  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)

  1st day

• Pelvic Floor Impact Questionnaire

  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

  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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: * 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 weight, exercised, sneezed or coughed?" and "In the last month, have you sensed very strong urge to urinate, leaking urine before getting to bathroom?"
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pakistani women suffering from urinary incontinence.

You may qualify if:

• 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?"

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Ripah International University

Faisalabad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Muhammad Kashif

  Riphah International University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 2, 2022
• Study Start: May 30, 2021
• Primary Completion: February 20, 2022
• Study Completion: February 28, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)