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OpenTrials
Completed

NCT Number: NCT04867876

Qol Following Management for Pediatric UI

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.

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Key information

Conditions

Quality of Life Incontinence

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Dakota

Vermillion, South Dakota, 57069, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical Therapy

Behavioral

Management of urinary incontinence by a physical therapist will include but is not limited to biofeedback, dietary management, alleviation of constipation, and neuromuscular re-education.

Primary outcomes

  1. Dysfunctional Voiding Symptom Scale

    Time frame: 3-6 months

    Voiding dysfunction evaluation; scale 0-3; score of 8.5 or more is symptomology threshold

  2. Kid KINDL Questionnaire

    Time frame: 3-6 months

    Quality of Life

Sponsors and collaborators

Lead sponsor

University of South Dakota

Other

Registry information

Official study title

Quality of Life Following Conservative Management for Pediatric Daytime Urinary Incontinence

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 30, 2021
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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