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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Afyonkarahisar Health Sciences University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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