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

Clinically Important or Just Statistically Significant? Minimal Clinically Important Difference for DVISS and PIN-Q in Children With Urinary Incontinence

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07242898
Enrollment
100
Registered
2025-11-21
Start date
2026-09-01
Completion date
2026-12-01
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Keywords

minimal clinically important difference, urinary incontinence, quality of life, ROC curve

Brief summary

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).

Detailed 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.

Interventions

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

Sponsors

Artvin Coruh University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

In this prospective study, one treatment group was formed to receive SU.

Eligibility

Sex/Gender
ALL
Age
5 Years to 13 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Dysfunctional Voiding and Incontinence Symptom Score (DVISS)BaselineDVISS 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

MeasureTime frameDescription
Pediatric Urinary Incontinence Quality of Life Questionnaire (PIN-Q)BaselineThis 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

MeasureTime frameDescription
Global Rating Change (GRC)At Week 8, immediately after completion of the 8-week interventionThe GRC comprised seven responses, ranging from 1 to 5, indicating very much better, slightly better, no change, slightly worse, and very much worse, respectively.

Contacts

Primary ContactZeynep Yıldız Kızkın
pt.zeynepyildiz@gmail.com+905346945085

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026