Clinical trial NCT04981873: UrduTranslation And Validation Of The Pelvic Floor Distress Inventory Short Form (PFDI-20)
Official title: Translation And Validation Of The Pelvic Floor Distress Inventory Short Form (PFDI-20) To Urdu Language
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Floor Disorders
Keywords: pelvic floor distress inventory
pelvic floor disorders
postmenupausal women
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 80
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Menopausal women aged 45 years and over

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Translatin and validation of Pelvic floor distress inventory short form(PFDI-20)
timeFrame: 6 months
Secondary outcomes:
measure: reliability
timeFrame: 6 months
Other outcomes:
measure: validity
timeFrame: 6 months
Locations:
city: Rawalpindi
country: Pakistan
facility: Margalla general hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sarah Ehsan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spino C, Whitehead WE, Wu J, Brody DJ; Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008 Sep 17;300(11):1311-6. doi: 10.1001/jama.300.11.1311.
citation: Mattsson NK, Nieminen K, Heikkinen AM, Jalkanen J, Koivurova S, Eloranta ML, Suvitie P, Tolppanen AM. Validation of the short forms of the Pelvic Floor Distress Inventory (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) in Finnish. Health Qual Life Outcomes. 2017 May 2;15(1):88. doi: 10.1186/s12955-017-0648-2.
citation: Kaplan PB, Sut N, Sut HK. Validation, cultural adaptation and responsiveness of two pelvic-floor-specific quality-of-life questionnaires, PFDI-20 and PFIQ-7, in a Turkish population. Eur J Obstet Gynecol Reprod Biol. 2012 Jun;162(2):229-33. doi: 10.1016/j.ejogrb.2012.03.004. Epub 2012 Apr 4.