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NCT Number: NCT07339657

Validity and Reliability of the PRAFAB

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Emel Taşvuran Horata

Afyonkarahisar, Merkez, 03030, Turkey (Türkiye)

Location status: Recruiting

Location contact

EMEL TAŞVURAN HORATA

CONTACT

[email protected]

05547759663

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Construct validity

Other

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

test-retest reliability

Other

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

EMEL TAŞVURAN HORATA

CONTACT

[email protected]

05547759663

Sponsors and collaborators

Lead sponsor

Afyonkarahisar Health Sciences University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

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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