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

NCT ID: NCT07242898

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-09-01

Study Completion Date

2026-12-01

Brief Summary

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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

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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.

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard urotherapy (SU)

Children with UI will receive SU as previously recommended.

Group Type EXPERIMENTAL

Standard Urotherapy (SU)

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Artvin Coruh University

OTHER

Sponsor Role lead

Responsible Party

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Zeynep Yıldız Kızkın

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zeynep Yıldız Kızkın

Role: PRINCIPAL_INVESTIGATOR

Artvin Coruh University

Central Contacts

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Zeynep Yıldız Kızkın

Role: CONTACT

+905346945085

References

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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.

Reference Type BACKGROUND
PMID: 39648965 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33510509 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30583907 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33478902 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32472266 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33148456 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36123285 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22236468 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10812317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31060913 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15711352 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33844342 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20044494 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20638823 (View on PubMed)

Other Identifiers

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MCID-3

Identifier Type: -

Identifier Source: org_study_id

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