Validity and Reliability of the PRAFAB

January 5, 2026 updated by: Emel Taşvuran Horata, Afyonkarahisar Health Sciences University

Evaluation of the Validity and Reliability of the Protection, Amount, Frequency, Compliance, Body Image (PRAFAB) Questionnaire in Women With Urinary Incontinence

PRAFAB assesses both the objective and subjective aspects of urinary incontinence. While differing from other questionnaires in this respect, it consists of only five questions. Today, there is a need for multidimensional and easy-to-use scales that can assess the effects of incontinence on quality of life. Therefore, the aim of this study is to conduct a Turkish validity and reliability study of the PRAFAB questionnaire in women with urinary incontinence.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRAFAB assesses both the objective and subjective aspects of urinary incontinence. While differing from other questionnaires in this respect, it consists of only five questions. Today, there is a need for multidimensional and easy-to-use scales that can assess the effects of incontinence on quality of life. Therefore, the aim of this study is to conduct a Turkish validity and reliability study of the PRAFAB questionnaire in women with urinary incontinence.

In this context, the study consists of two phases. In the first phase, the PRAFAB questionnaire was translated into Turkish and culturally adapted; in the second phase, the validity and reliability analyses of the Turkish version of the PRAFAB questionnaire (PRAFAB-Turkish) were conducted.

The study will be conducted by Afyonkarahisar University of Health Sciences. Participants consisted of women who presented as outpatients at the AFSU Health Application and Research Center Urology Clinic and were diagnosed with urinary incontinence by a urologist.

Study Type

Observational

Enrollment (Estimated)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Merkez
      • Afyonkarahisar, Merkez, Turkey (Türkiye), 03030
        • Recruiting
        • Emel Taşvuran Horata
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants aged 18 years and older with female urinary incontinence will be included in the study. Participants will consist of women who visit the AFSU Health Application and Research Center Urology Outpatient Clinic and are diagnosed with urinary incontinence by a urologist.

Description

Inclusion Criteria:

  • Being 18 years of age or older
  • Have been diagnosed with urinary incontinence by a urologist
  • Be female

Exclusion Criteria:

  • Being pregnant,
  • Being in the early postpartum period,
  • Have been diagnosed with bladder cancer, diabetic nephropathy, a history of central nervous system damage, congenital urological disorders, urinary tract infection, neurogenic bladder, severe cognitive impairment, and severe psychiatric illness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Urinary Incontinence
All subtypes of urinary incontinence (stress urinary incontinence, urge incontinence, etc.) were included in our study.
Other: Construct validity
This is not an intervention. This is an analysis conducted to examine the factor structure of this questionnaire. The analysis will be performed using the SPSS 26.0 software package program.
Other Names:
  • Exploratory Factor Analysis
Other: Test-retest reliability
This is not an intervention. This is an analysis conducted to examine the repeatability of this questionnaire. The analysis will be performed using the SPSS 26.0 software package program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PRAFAB
Time Frame: This questionnaire, which takes approximately 2-3 minutes to complete, will be administered to participants twice at two-week intervals.
It is a 5-item questionnaire. Developed to assess the severity of urinary incontinence and its impact on the individual.
This questionnaire, which takes approximately 2-3 minutes to complete, will be administered to participants twice at two-week intervals.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Afyonkarahisar Health Sciences University

Investigators

  • Principal Investigator: EMEL TAŞVURAN HORATA, Afyonkarahisar Sağlık Bİlimleri Üniversitesi
  • Study Chair: Şeyma Betül İNCE, No Affiliation
  • Study Chair: Harun TAŞKIN, PhD, Afyonkarahisar Health Sciences University
  • Study Chair: Osman GERÇEK, MD, Afyonkarahisar Health Sciences University
  • Study Chair: Mustafa Esat İNCE, MD, Afyonkarahisar Health Sciences University
  • Study Chair: Bary Berghmans, Assoc. Prof., Maastricht University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2024

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

August 15, 2026

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 291

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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