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Completed

NCT Number: NCT04981873

UrduTranslation And Validation Of The Pelvic Floor Distress Inventory Short Form (PFDI-20)

To translate and culturally adapt PELVIC FLOOR DISTRESS INVENTORY SHORT FORM (PFDI-20) into Urdu and To evaluate the reliability and validity of Urdu version of Pelvic floor distress inventory (short form).Urdu is the national language of Pakistan. The PFDI-20 has not been translated into Urdu so far. In order to use in Urdu speaking people, it is necessary to translate and culturally adapt PFDI-20 into Urdu language, so that it can be better understood by this population.

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Key information

Conditions

Pelvic Floor Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pregnancy Complications Urogenital Diseases

Age range

45 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Margalla general hospital

Rawalpindi, Punjab Province, 46350, Pakistan

About this study

Pelvic floor disorders, which include urinary incontinence, fecal incontinence, and pelvic organ prolapse, are highly prevalent conditions in women, affecting overall, almost 25% of women in the United States Because there are different types of pelvic floor disorders (PFDs), symptoms of different PFDs can vary or overlap. For example, women with PFDs may feel: heaviness, fullness, pulling, or aching in the vagina that gets worse by the end of the day or is related to a bowel movement; See or feel a "bulge" or "something coming out" of the vagina, have difficulty starting to urinate or emptying the bladder completely, leak urine when coughing, laughing, or exercising, feel an urgent or frequent need to urinate, feel pain while urinating, leak stool or have difficulty controlling gas, have constipation and have difficulty making it to the bathroom in time PFDI-20 has been translated into many languages across the globe to check the validity, reliability and responsiveness of the scale, in their native languages.

A study was conducted to assess validity of PFDI-20 in Finnish by using Multistep translation method with sample size of 63, they found it a valid tool.

In Turkish language validity and reliability of this tool was addressed on larger number of women and was recommended as valid and reliable tool

Who can participate

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

Inclusion criteria

  • Menopausal women aged 45 years and older, those who can read and understand Urdu language

Exclusion criteria

  • Previous pelvic surgery, Malignant tumor, Cognitive impairment and Dementia

Treatment and study plan

Primary outcomes

  1. Translatin and validation of Pelvic floor distress inventory short form(PFDI-20)

    Time frame: 6 months

    The Pelvic Floor Distress Inventory-20 is to measure health related quality of life of females suffering from pelvic floor disorders. it contains 3 scales and total 20 questions.3 scales are Urinary distress inventory,Pelvic organ prolapse distress inventory and Colorectal-anal distress inventory.Each question indicate presence of symptom by marking YES/NO and further describes the degree of discomfort by 4 variables,NOT AT ALL,SOMEWHAT,MODERATELY and QUITE A BIT.

Secondary outcomes

  1. reliability

    Time frame: 6 months

    To determine reliability of Pelvic floor distress inventory short form(PFDI-20) in (URDU) language. reliability refers to ability of a measure to produce same results administered at two or more intervals. Thus this will be test through test retest reliability

Other outcomes

  1. validity

    Time frame: 6 months

    to determine the validity of translation of PFDI-20 in (URDU) language. Validity is defined as how accurate the results are. Thus this will be measured through various parameters

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Translation And Validation Of The Pelvic Floor Distress Inventory Short Form (PFDI-20) To Urdu Language

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 29, 2021
Registry last updated
Apr 22, 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.

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