Validity and Reliability of the PRAFAB | NCT07339657

Studies
Validity and Reliability of the PRAFAB

NCT07339657

Sponsor

Afyonkarahisar Health Sciences University

Status

Recruiting

Last Update Posted

Jan 14, 2026Actual

Enrollment

63Estimated

Phase

Not provided

Conditions

Urinary Incontinence

Interventions

Construct validity
Test-retest reliability

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2024Actual

Primary Completion Date

Aug 15, 2026Estimated

Completion Date

Aug 15, 2026Estimated

First Submitted Date

Jan 5, 2026

First Submission Date that Met QC Criteria

Jan 5, 2026

First Posted Date

Jan 14, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2026

Last Update Posted Date

Jan 14, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Emel Taşvuran Horata, PhD; Associate Professor, Afyonkarahisar Health Sciences UniversityPrincipal Investigator

Lead Sponsor

Afyonkarahisar Health Sciences UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

63Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
EMEL TAŞVURAN HORATA	Contact	05547759663		ethorata@gmail.com

Overall Officials

Name	Affiliation	Role
EMEL TAŞVURAN HORATA	Afyonkarahisar Sağlık Bİlimleri Üniversitesi	Principal Investigator
Şeyma Betül İNCE	No Affiliation	Study Chair
Harun TAŞKIN, PhD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emel Taşvuran Horata	Recruiting	Afyonkarahisar	Merkez	03030	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D014549	Urinary Incontinence

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015203	Reproducibility of Results

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D005069	Evaluation Studies as Topic

Browse Leaves

Not provided

Browse Branches

Not provided