Clinically Important or Just Statistically Significant? MCID for DVISS and PIN-Q in Children With UI

Artvin Coruh University

Status: Begins enrollment in 6 months

Conditions: Urinary Incontinence

Treatments: Other: Standard Urotherapy (SU)

Study type: Interventional

Funder types: Other

Identifiers

NCT07242898

MCID-3

Details and patient eligibility

About

The goal of this study was to determine the Minimal Clinically Important Difference (MCID) for the Dysfunctional Voiding and Incontinence Symptom Score (DVISS) and the Pediatric Incontinence Questionnaire (PIN-Q) in children with urinary incontinence (UI).

Full description

100 children with UI will receive standard urotherapy (SU) for 8 weeks. UI-related symptoms and quality of life (QoL) will be assessed with the DVISS and PIN-Q baseline and after treatment. The receiver operating characteristic (ROC) analysis and the Gamma coefficient will be employed to assess responsiveness.

Enrollment: 100 estimated patients

Sex: All

Ages: 5 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of UI according to the International Children's Continence Society (ICCS) Guideline,
• children aged 5-13 years (when UI becomes more prevalent in children).

Exclusion criteria

• congenital anomalies of the uro-genital system,
• only neurogenic bladder dysfunction.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Standard urotherapy (SU)

Experimental group

Description:

Children with UI will receive SU as previously recommended.

Treatment:

Other: Standard Urotherapy (SU)