NCT04981873

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

July 19, 2021

Last Update Submit

April 21, 2022

Conditions

Keywords

pelvic floor distress inventorypelvic floor disorderspostmenupausal women

Outcome Measures

Primary Outcomes (1)

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

    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.

    6 months

Secondary Outcomes (1)

  • reliability

    6 months

Other Outcomes (1)

  • validity

    6 months

Eligibility Criteria

Age45 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspelvic floor disorders are most common in females
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Menopausal women aged 45 years and over

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Margalla general hospital

Rawalpindi, Punjab Province, 46350, Pakistan

Location

Related Publications (3)

  • 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.

    PMID: 18799443BACKGROUND
  • 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.

    PMID: 28464936BACKGROUND
  • 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.

    PMID: 22480412BACKGROUND

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Study Officials

  • Sarah Ehsan

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2021

First Posted

July 29, 2021

Study Start

August 15, 2020

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

April 22, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations