Qol Following Management for Pediatric UI

Quality of Life Clinical Trial

Official title:

Quality of Life Following Conservative Management for Pediatric Daytime Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04867876
• Other study ID #: QOL after UI treatment
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: February 2016

Study information

• Verified date: April 2021
• Source: University of South Dakota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Incontinence
• Quality of Life

Intervention

Behavioral:
• Physical Therapy
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.

Locations

Country	Name	City	State
United States	University of South Dakota	Vermillion	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
University of South Dakota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysfunctional Voiding Symptom Scale	Voiding dysfunction evaluation; scale 0-3; score of 8.5 or more is symptomology threshold	3-6 months
Primary	Kid KINDL Questionnaire	Quality of Life	3-6 months