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

NCT07242898 | Not Yet Recruiting

• 1 other identifier: MCID-3
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Urinary Incontinence

Keywords

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

Outcome Measures

Primary Outcomes (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.

  Baseline

• 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.

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

Secondary Outcomes (2)

• Pediatric Urinary Incontinence Quality of Life Questionnaire (PIN-Q)

  Baseline

• Pediatric Urinary Incontinence Quality of Life Questionnaire (PIN-Q)

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

Other Outcomes (1)

• Global Rating Change (GRC)

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

Study Arms (1)

Standard urotherapy (SU)

EXPERIMENTAL

Children with UI will receive SU as previously recommended.

Other: Standard Urotherapy (SU)

Interventions

Standard Urotherapy (SU) OTHER

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

Standard urotherapy (SU)

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• congenital anomalies of the uro-genital system,
• only neurogenic bladder dysfunction.

Sponsors & Collaborators

• Artvin Coruh University: lead

Related Publications (14)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Husted JA, Cook RJ, Farewell VT, Gladman DD. Methods for assessing responsiveness: a critical review and recommendations. J Clin Epidemiol. 2000 May;53(5):459-68. doi: 10.1016/s0895-4356(99)00206-1.

  PMID: 10812317 BACKGROUND

• Nieuwhof-Leppink AJ, Schroeder RPJ, van de Putte EM, de Jong TPVM, Schappin R. Daytime urinary incontinence in children and adolescents. Lancet Child Adolesc Health. 2019 Jul;3(7):492-501. doi: 10.1016/S2352-4642(19)30113-0. Epub 2019 May 4.

  PMID: 31060913 BACKGROUND

• Akbal C, Genc Y, Burgu B, Ozden E, Tekgul S. Dysfunctional voiding and incontinence scoring system: quantitative evaluation of incontinence symptoms in pediatric population. J Urol. 2005 Mar;173(3):969-73. doi: 10.1097/01.ju.0000152183.91888.f6.

  PMID: 15711352 BACKGROUND

• Frawley H, Shelly B, Morin M, Bernard S, Bo K, Digesu GA, Dickinson T, Goonewardene S, McClurg D, Rahnama'i MS, Schizas A, Slieker-Ten Hove M, Takahashi S, Voelkl Guevara J. An International Continence Society (ICS) report on the terminology for pelvic floor muscle assessment. Neurourol Urodyn. 2021 Jun;40(5):1217-1260. doi: 10.1002/nau.24658. Epub 2021 Apr 12.

  PMID: 33844342 BACKGROUND

• Greco NJ, Anderson AF, Mann BJ, Cole BJ, Farr J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010 May;38(5):891-902. doi: 10.1177/0363546509354163. Epub 2009 Dec 31.

  PMID: 20044494 BACKGROUND

• Lehman LA, Velozo CA. Ability to detect change in patient function: responsiveness designs and methods of calculation. J Hand Ther. 2010 Oct-Dec;23(4):361-70; quiz 371. doi: 10.1016/j.jht.2010.05.003. Epub 2010 Jul 17.

  PMID: 20638823 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zeynep Yıldız Kızkın

  Artvin Coruh University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeynep Yıldız Kızkın

CONTACT

+905346945085; pt.zeynepyildiz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

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

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 21, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share