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

No phase Interventional Urinary Incontinence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard Urotherapy (SU).
Who it may be relevant to
Registry conditions: Urinary Incontinence. Basic parameters: 5 years — 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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

Primary outcome measures

  • Dysfunctional Voiding and Incontinence Symptom Score (DVISS) [Time frame: Baseline]
  • Dysfunctional Voiding and Incontinence Symptom Score (DVISS) [Time frame: At Week 8, immediately after completion of the 8-week intervention]
Secondary outcome measures (2)
  • Pediatric Urinary Incontinence Quality of Life Questionnaire (PIN-Q) [Time frame: Baseline]
  • Pediatric Urinary Incontinence Quality of Life Questionnaire (PIN-Q) [Time frame: At Week 8, immediately after completion of the 8-week intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Watanabe Y, Ikeda H, Ono T, Oyake C, Endo S, Onuki Y, Fuyama M, Watanabe T. Prevalence of Urinary Incontinence and Its Association With Neurodevelopmental Disorders Among Children in Japan. Neurourol Urodyn. 2025 Feb;44(2):458-463. doi: 10.1002/nau.25637. Epub 2024 Dec 9. PMID 39648965
  • Shrestha N, Sahukhala S, K C D, Sandalcidi D, Adhikari SP. Prevalence of Urinary Incontinence in School Going Children: A Cross-sectional Study. J Nepal Health Res Counc. 2021 Jan 21;18(4):676-680. doi: 10.33314/jnhrc.v18i4.2506. PMID 33510509
  • Linde JM, Nijman RJM, Trzpis M, Broens PMA. Prevalence of urinary incontinence and other lower urinary tract symptoms in children in the Netherlands. J Pediatr Urol. 2019 Apr;15(2):164.e1-164.e7. doi: 10.1016/j.jpurol.2018.10.027. Epub 2018 Nov 8. PMID 30583907
  • Nieuwhof-Leppink AJ, Hussong J, Chase J, Larsson J, Renson C, Hoebeke P, Yang S, von Gontard A. Definitions, indications and practice of urotherapy in children and adolescents: - A standardization document of the International Children's Continence Society (ICCS). J Pediatr Urol. 2021 Apr;17(2):172-181. doi: 10.1016/j.jpurol.2020.11.006. Epub 2020 Nov 5. PMID 33478902
  • Tekgul S, Stein R, Bogaert G, Undre S, Nijman RJM, Quaedackers J, 't Hoen L, Kocvara R, Silay MS, Radmayr C, Dogan HS. EAU-ESPU guidelines recommendations for daytime lower urinary tract conditions in children. Eur J Pediatr. 2020 Jul;179(7):1069-1077. doi: 10.1007/s00431-020-03681-w. PMID 32472266
  • Malhotra NR, Kuhlthau KA, Rosoklija I, Migliozzi M, Nelson CP, Schaeffer AJ. Children's experience with daytime and nighttime urinary incontinence - A qualitative exploration. J Pediatr Urol. 2020 Oct;16(5):535.e1-535.e8. doi: 10.1016/j.jpurol.2020.10.002. Epub 2020 Oct 18. PMID 33148456
  • Nacif A, de Abreu GE, Bessa Junior J, Veiga ML, Barroso U. Agreement between the visual analogue scale (VAS) and the dysfunctional voiding scoring system (DVSS) in the post-treatment evaluation of electrical nerve stimulation in children and adolescents with overactive bladder. J Pediatr Urol. 2022 Dec;18(6):740.e1-740.e8. doi: 10.1016/j.jpurol.2022.07.032. Epub 2022 Aug 3. PMID 36123285
  • Thibodeau BA, Metcalfe P, Koop P, Moore K. Urinary incontinence and quality of life in children. J Pediatr Urol. 2013 Feb;9(1):78-83. doi: 10.1016/j.jpurol.2011.12.005. Epub 2012 Jan 10. PMID 22236468

Identifiers

NCT: NCT07242898 · MCID-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗