Urinary IncontinenceNCT07339657
Validity and Reliability of the PRAFAB
An observational study of Urinary Incontinence, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Construct validity and Test-retest reliability
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 15 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- Being 18 years of age or older
- Have been diagnosed with urinary incontinence by a urologist
- Be female
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Emel Taşvuran Horata
Afyonkarahisar, Merkez, 03030
EMEL TAŞVURAN HORATA, 05547759663, ethorata@gmail.com
About this study
Official title: 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.
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.
- Conditions
- Urinary Incontinence
- Being tested
- Construct validity, Test-retest reliability
- Keywords
- urinary incontinence, validity, reliability
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Construct validityOther
Also called Exploratory Factor Analysis
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.
Test-retest reliabilityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Urinary Incontinence | All subtypes of urinary incontinence (stress urinary incontinence, urge incontinence, etc.) were included in our study. Receives: Other: Construct validity; Other: Test-retest reliability |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRAFAB
It is a 5-item questionnaire. Developed to assess the severity of urinary incontinence and its impact on the individual.
Measured: This questionnaire, which takes approximately 2-3 minutes to complete, will be administered to participants twice at two-week intervals.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start15 Oct 2024
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Taşvuran Horata, Afyonkarahisar Health Sciences University
- Investigators
- EMEL TAŞVURAN HORATA, Principal investigator, Afyonkarahisar Sağlık Bİlimleri ÜniversitesiŞeyma Betül İNCE, Study chair, No AffiliationHarun TAŞKIN, PhD, Study chair, Afyonkarahisar Health Sciences UniversityOsman GERÇEK, MD, Study chair, Afyonkarahisar Health Sciences UniversityMustafa Esat İNCE, MD, Study chair, Afyonkarahisar Health Sciences UniversityBary Berghmans, Assoc. Prof., Study chair, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339657
- Sponsor's protocol ID
- 291
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tasvuran Horata E, Ince SB, Taskin H, Gercek O, Ince ME, Berghmans B. Validity and reliability of the Turkish version of the PRAFAB questionnaire in individuals with urinary incontinence. Disabil Rehabil. 2026 Sep 8:1-13. doi: 10.1080/09638288.2026.2729417. Online ahead of print.
PubMed 42708641
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Validity and Reliability of the Protection, Amount, Frequency, Compliance, Body Image (PRAFAB) Questionnaire in Women With Urinary Incontinence
- ClinicalTrials.gov ID
- NCT07339657
- Acronym / sponsor ID
- 291
- Conditions
- Urinary Incontinence
- Keywords
- urinary incontinence, validity, reliability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urinary Incontinence | – | Other: Construct validity, Other: Test-retest reliabilityAll subtypes of urinary incontinence (stress urinary incontinence, urge incontinence, etc.) were included in our study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- Being 18 years of age or older
- Have been diagnosed with urinary incontinence by a urologist
- Be female
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Construct validityAlso: Exploratory Factor AnalysisThis 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 | Urinary Incontinence |
| Test-retest reliabilityThis 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. | Other | Urinary Incontinence |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Derived from this study: PubMed 42708641Tasvuran Horata E, Ince SB, Taskin H, Gercek O, Ince ME, Berghmans B. Validity and reliability of the Turkish version of the PRAFAB questionnaire in individuals with urinary incontinence. Disabil Rehabil. 2026 Sep 8:1-13. doi: 10.1080/09638288.2026.2729417. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EMEL TAŞVURAN HORATA (05547759663, ethorata@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07339657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.