DEVELOPMENT AND VALIDATION OF THE URINARY INCONTINENCE KINESIOPHOBIA SEVERITY SCALE

NCT07842575 | Recruiting

• 1 other identifier: KAEU-EBAYRAMOGLUD-010
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop and validate a novel Turkish-language self-report instrument, the Kinesiophobia Severity Scale in Urinary Incontinence (KSS-UI), to assess movement avoidance and fear of movement associated with concerns about urinary leakage in individuals with urinary incontinence. Following scale development, its validity and reliability will be evaluated through psychometric analyses in accordance with the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) recommendations.

Conditions

Incontinence

Keywords

Incontinence; Kinesiofobia

Outcome Measures

Primary Outcomes (1)

• Content Validity of the Kinesiophobia Severity Scale in Urinary Incontinence (KSS-UI)

  The content validity of the newly developed scale will be evaluated by a multidisciplinary panel of at least 10 experts. Item relevance, clarity, simplicity, and necessity will be assessed using the Content Validity Ratio (CVR), Item-level Content Validity Index (I-CVI), Scale-level Content Validity Index (S-CVI), and modified kappa statistics.

  During the initial expert evaluation, before participant recruitment for the main validation study.

Secondary Outcomes (2)

• Internal Consistency of the KSS-UI

  Baseline (single assessment session; approximately 15-20 minutes).

• Item Discrimination and Item Performance of the KSS-UI

  Baseline (single assessment session; approximately 15-20 minutes).

Study Arms (1)

Incontinance

This group will consist of individuals with urinary incontinence, including stress, urgency, and mixed urinary incontinence, who are recruited from among relatives of patients attending the Physical Therapy and Rehabilitation Center. Eligible participants who voluntarily agree to participate will complete the newly developed Kinesiophobia Severity Scale in Urinary Incontinence (KSS-UI) to assess fear of movement and movement avoidance associated with concerns about urinary leakage. The scale will undergo psychometric evaluation to assess its validity and reliability. No therapeutic intervention will be administered as part of the study.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adults aged 18 years or older who report urinary incontinence, including stress, urgency, and mixed urinary incontinence. Participants will be recruited from among relatives of patients attending the Physical Therapy and Rehabilitation Center. Eligible individuals who report urinary leakage at least once per week during the past three months, are able to read and understand Turkish, and voluntarily agree to participate will be included in the study. Individuals with active lower urinary tract infections or conditions that prevent independent completion of the questionnaires will be excluded.

You may qualify if:

• Being 18 years of age or older
• Reporting symptoms of incontinence at least once a week for the past 3 months (ICIQ-SF score ≥ 1)
• Having the ability to read and comprehend Turkish
• Having been informed about the study and provided written informed consent

You may not qualify if:

• Having an active lower urinary tract infection
• Inability to complete the scales independently due to cognitive impairment, advanced dementia, or limited literacy
• Individuals who refuse to participate in the study or do not sign the informed consent form

Sponsors & Collaborators

• Ahi Evran University Education and Research Hospital: lead

Study Sites (1)

Kırşehir Ahi Evran Üniversitesi

Kırşehir, Kırşehir, 40100, Turkey (Türkiye)

RECRUITING

Study Officials

• Esra BAYRAMOĞLU DEMİRDÖĞEN

  Kırşehir Eğitim ve Araştırma Hastanesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esra BAYRAMOĞLU DEMİRDÖĞEN

CONTACT

05426961169; esra.bayramoglu@ahievran.edu.tr

Esra BAYRAMOĞLU DEMİRDÖĞEN

CONTACT

5426961169; esra.bayramoglu@ahievran.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 25, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)