Qol Following Management for Pediatric UI

April 29, 2021 updated by: Patti Berg-Poppe, University of South Dakota

Quality of Life Following Conservative Management for Pediatric Daytime Urinary Incontinence

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Dakota
      • Vermillion, South Dakota, United States, 57069
        • University of South Dakota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Cohort
Physical Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dysfunctional Voiding Symptom Scale
Time Frame: 3-6 months
Voiding dysfunction evaluation; scale 0-3; score of 8.5 or more is symptomology threshold
3-6 months
Kid KINDL Questionnaire
Time Frame: 3-6 months
Quality of Life
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Dakota

Investigators

  • Principal Investigator: Patti J. Berg-Poppe, PhD, University of South Dakota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

January 6, 2015

First Submitted That Met QC Criteria

April 29, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

May 5, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • QOL after UI treatment

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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