Qol Following Management for Pediatric UI

Not Applicable

Completed

• Conditions: Quality of Life; Incontinence
• Interventions: Behavioral: Physical Therapy

• Registration Number: NCT04867876
• Lead Sponsor: University of South Dakota

Brief Summary

A comparison of changes between symptoms of incontinence and pediatric quality of life will be used to draw conclusions about whether differences in quality of life are noted with changes in symptoms of incontinence.

Detailed Description

Although positive physiological results are associated with successful treatment for bowel and bladder dysfunction and daytime incontinence (BD-UI), there are few studies examining the effects of treatment on quality of life (QoL) for children. The purpose of our study is to determine whether successful physical therapy treatment improves QoL for children with BD-UI.

Consent will be obtained from parents and assent from children. Children will be asked to complete a global, age appropriate quality of life assessment and a quality of life instrument specific to incontinence. Information will be provided by the parent through completion of a parent report instrument matched to the child's global quality of life tool as well as completion of an instrument depicting child symptoms. Clinicians will report general information about related physiological changes and progress with established outcomes individualized to the child. A repeated measures MANOVA will be used to analyze the results.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2015-01-06
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-29
• Last Update Submitted: 2021-04-29
• Study First Posted: 2021-04-30
• Last Update Posted: 2021-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Children between ages 5-18 who were currently receiving conservative treatment for daytime UI with or without constipation or encopresis met inclusion criteria.

Exclusion Criteria

• Exclusion criteria included children who only had nocturnal enuresis or children with neurogenic bladders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Cohort	Physical Therapy	Physical Therapy

Primary Outcome Measures

Name	Time	Method
Dysfunctional Voiding Symptom Scale	3-6 months	Voiding dysfunction evaluation; scale 0-3; score of 8.5 or more is symptomology threshold
Kid KINDL Questionnaire	3-6 months	Quality of Life

Trial Locations

Locations (1)

University of South Dakota; 🇺🇸 Vermillion, South Dakota, United States