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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-13
SponsorArtvin Coruh University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Standard Urotherapy (SU)

    Other intervention

    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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Standard urotherapy (SU)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
At Week 8, immediately after completion of the 8-week intervention

Secondary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
At Week 8, immediately after completion of the 8-week intervention

Other outcomes

1

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.

Time frame
At Week 8, immediately after completion of the 8-week intervention

Locations

This trial has no locations.

Sponsors and contacts

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