Skip to main content
OpenTrials
Completed

NCT Number: NCT05221034

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Ripah International University

Faisalabad, Punjab Province, 38000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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)

  3. 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).

  4. 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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Cross-Cultural Adaptation, Reliability, Validity, and Responsiveness of the Urdu Version of Questionnaire for Female Urinary Incontinence Diagnosis

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 2, 2022
Registry last updated
Jul 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.