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RecruitingNCT07339657Updated Jan 14, 2026

Validity and Reliability of the PRAFAB

An observational study in Urinary Incontinence, sponsored by Afyonkarahisar Health Sciences University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-14.

Sponsored by Afyonkarahisar Health Sciences University · Observational

From the registry’s dates

  • Started Oct 2024; still recruiting 1 year 11 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
63
Ages
18 Years and older
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Urinary Incontinence

Keywords

  • urinary incontinence
  • validity
  • reliability
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's planned enrollment of 63 is below the median of 120 across 305 observational studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Afyonkarahisar Health Sciences University is the lead sponsor of 107 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
63 participants (estimated)
Patient registry
No

Groups and cohorts

  • Urinary Incontinence

    All subtypes of urinary incontinence (stress urinary incontinence, urge incontinence, etc.) were included in our study.

    Other: Construct validity · Other: Test-retest reliability

Interventions

  • OtherConstruct 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.

    Also known as: Exploratory Factor Analysis

  • OtherTest-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.

06

What researchers measure

Primary outcomes

  1. PRAFAB

    It is a 5-item questionnaire. Developed to assess the severity of urinary incontinence and its impact on the individual.

    Time frame: This questionnaire, which takes approximately 2-3 minutes to complete, will be administered to participants twice at two-week intervals.

07

Study locations

1 of 1 sites recruiting
  • Emel Taşvuran Horata
    Afyonkarahisar, Merkez 03030, Turkey (Türkiye)
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07339657
Lead sponsor
Afyonkarahisar Health Sciences University
Responsible party
Emel Taşvuran Horata (PhD; Associate Professor, Afyonkarahisar Health Sciences University) — Principal investigator
First posted
Jan 14, 2026
Start date
Oct 15, 2024
Primary completion
Aug 15, 2026 (estimated)
Completion
Aug 15, 2026 (estimated)
Last update
Jan 14, 2026

Study contacts

EMEL TAŞVURAN HORATA
Contact
ethorata@gmail.com
05547759663
EMEL TAŞVURAN HORATA
principal investigator · Afyonkarahisar Sağlık Bİlimleri Üniversitesi
Şeyma Betül İNCE
study chair · No Affiliation
Harun TAŞKIN, PhD
study chair · Afyonkarahisar Health Sciences University
Osman GERÇEK, MD
study chair · Afyonkarahisar Health Sciences University
Mustafa Esat İNCE, MD
study chair · Afyonkarahisar Health Sciences University
Bary Berghmans, Assoc. Prof.
study chair · Maastricht University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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