- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04867876
Qol Following Management for Pediatric UI
Quality of Life Following Conservative Management for Pediatric Daytime Urinary Incontinence
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Dakota
-
Vermillion, South Dakota, United States, 57069
- University of South Dakota
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
Sponsor
Investigators
- Principal Investigator: Patti J. Berg-Poppe, PhD, University of South Dakota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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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