DEVELOPMENT AND VALIDATION OF THE URINARY INCONTINENCE KINESIOPHOBIA SEVERITY SCALE

ConditionIncontinence
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAhi Evran University Education and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 1 trial group
Group A: Incontinance

Trial outcomes

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.

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

Secondary outcomes

1

Internal Consistency of the KSS-UI

The internal consistency of the KSS-UI will be evaluated using Cronbach's alpha coefficient and corrected item-total correlations. The contribution of individual items to scale reliability will also be examined.

Time frame
Baseline (single assessment session; approximately 15-20 minutes).
2

Item Discrimination and Item Performance of the KSS-UI

Item performance will be evaluated by examining item distributions, floor and ceiling effects, and corrected item-total correlations. Item discrimination will be assessed by comparing item scores between the upper and lower 27% of participants based on total scale scores.

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

Other outcomes

Sponsors and contacts

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