NCT Number: NCT07242898
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).
Trial opening soon.
Get Notified5 year–13 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SU 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
Time frame: Baseline
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.
Time frame: At Week 8, immediately after completion of the 8-week intervention
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.
Time frame: Baseline
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.
Time frame: At Week 8, immediately after completion of the 8-week intervention
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.
Time frame: At Week 8, immediately after completion of the 8-week intervention
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.
Contact information is provided by the study sponsor or research team.
Artvin Coruh University
Other
Clinically Important or Just Statistically Significant? Minimal Clinically Important Difference for DVISS and PIN-Q in Children With Urinary Incontinence
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