NCT07339657

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress85%
Oct 2024Aug 2026

Study Start

First participant enrolled

October 15, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

January 5, 2026

Last Update Submit

January 5, 2026

Conditions

Keywords

urinary incontinencevalidityreliability

Outcome Measures

Primary Outcomes (1)

  • PRAFAB

    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.

Study Arms (1)

Urinary Incontinence

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

Other: Construct validityOther: Test-retest reliability

Interventions

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
Urinary Incontinence

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.

Urinary Incontinence

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emel Taşvuran Horata

Afyonkarahisar, Merkez, 03030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Reproducibility of Results

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesEvaluation Studies as TopicHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • EMEL TAŞVURAN HORATA

    Afyonkarahisar Sağlık Bİlimleri Üniversitesi

    PRINCIPAL INVESTIGATOR
  • 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 CHAIR

Central Study Contacts

EMEL TAŞVURAN HORATA

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD; Associate Professor

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 14, 2026

Study Start

October 15, 2024

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations