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CompletedNCT04867876Updated May 5, 2021

Qol Following Management for Pediatric UI

An interventional study of Physical Therapy in Quality of Life and Incontinence, sponsored by University of South Dakota. Completed at 1 site in United States. Open to participants aged 5 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-05.

Sponsored by University of South Dakota · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled May 2014, registered Jan 2015).
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
5 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Quality of Life
  • Incontinence

Keywords

  • Quality of Life
  • Pediatric
  • Incontinence
03

In context

Lead sponsor

University of South Dakota is the lead sponsor of 14 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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:

  • Exclusion criteria included children who only had nocturnal enuresis or children with neurogenic bladders.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Intervention Cohort

    Physical Therapy

    Behavioral: Physical Therapy

Interventions

  • BehavioralPhysical 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.

06

What researchers measure

Primary outcomes

  1. Dysfunctional Voiding Symptom Scale

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

    Time frame: 3-6 months

  2. Kid KINDL Questionnaire

    Quality of Life

    Time frame: 3-6 months

07

Study locations

1 site
  • University of South Dakota
    Vermillion, South Dakota 57069, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04867876
Lead sponsor
University of South Dakota
Responsible party
Patti Berg-Poppe (Associate Professor, University of South Dakota) — Principal investigator
First posted
Apr 30, 2021
Start date
May 2014
Primary completion
Feb 2016
Completion
Feb 2016
Last update
May 5, 2021

Study contacts

Patti J. Berg-Poppe, PhD
principal investigator · University of South Dakota

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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