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

November 19, 2025 updated by: Zeynep Yıldız Kızkın, Artvin Coruh University

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard urotherapy (SU)
Children with UI will receive SU as previously recommended.
Other: Standard Urotherapy (SU)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dysfunctional Voiding and Incontinence Symptom Score (DVISS)
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.
Baseline
Dysfunctional Voiding and Incontinence Symptom Score (DVISS)
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.
At Week 8, immediately after completion of the 8-week intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Urinary Incontinence Quality of Life Questionnaire (PIN-Q)
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.
Baseline
Pediatric Urinary Incontinence Quality of Life Questionnaire (PIN-Q)
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.
At Week 8, immediately after completion of the 8-week intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Rating Change (GRC)
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.
At Week 8, immediately after completion of the 8-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Artvin Coruh University

Investigators

  • Principal Investigator: Zeynep Yıldız Kızkın, Artvin Çoruh University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 15, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCID-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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