About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
congenital anomalies of the uro-genital system,
only neurogenic bladder dysfunction.
Trial design
Single group
Treatments tested in this trial
Standard Urotherapy (SU)
Other interventionSU will be included appropriate provision of information and demystification, lifestyle advice, instructions, behavioral modifications to achieve optimal bladder and bowel habits, registration of symptoms and voiding habits, support, and encouragement
Treatment groups
Trial outcomes
Primary outcomes
Dysfunctional Voiding and Incontinence Symptom Score (DVISS)
DVISS includes 14 items: 13 assess lower urinary tract symptoms (LUTS), voiding and defecation habits day and night, and one evaluates impact on severity and daily life activities (DLA). A score of 8.5+ indicates abnormal voiding; higher scores mean more severe disease.
Dysfunctional Voiding and Incontinence Symptom Score (DVISS)
DVISS includes 14 items: 13 assess lower urinary tract symptoms (LUTS), voiding and defecation habits day and night, and one evaluates impact on severity and daily life activities (DLA). A score of 8.5+ indicates abnormal voiding; higher scores mean more severe disease.
Secondary outcomes
Pediatric Urinary Incontinence Quality of Life Questionnaire (PIN-Q)
This 4-point Likert scale assesses the emotional impact of UI on a child, with 20 questions and a maximum score of 80. Higher scores mean a greater impact on QoL: 0-20 is mild, 21-50 moderate, and 51+ severe.
Pediatric Urinary Incontinence Quality of Life Questionnaire (PIN-Q)
This 4-point Likert scale assesses the emotional impact of UI on a child, with 20 questions and a maximum score of 80. Higher scores mean a greater impact on QoL: 0-20 is mild, 21-50 moderate, and 51+ severe.
Other outcomes
Global Rating Change (GRC)
The GRC comprised seven responses, ranging from 1 to 5, indicating "very much better," "slightly better," "no change," "slightly worse," and "very much worse," respectively.
Locations
Sponsors and contacts
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