Qol Following Management for Pediatric UI

• Sponsor: University of South Dakota (Other)
• Overall Status: Completed
• CT.gov ID: NCT04867876
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Actual Duration (Months): 21.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Quality of Life; Incontinence	Behavioral: Physical Therapy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Quality of Life Following Conservative Management for Pediatric Daytime Urinary Incontinence
• Actual Study Start Date: May 1, 2014
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Dysfunctional Voiding Symptom Scale [3-6 months]

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

2. Kid KINDL Questionnaire [3-6 months]

   Quality of Life

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 18 Years
• Sexes Eligible for Study: 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 included children who only had nocturnal enuresis or children with neurogenic bladders.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Dakota	Vermillion	South Dakota	United States	57069

Sponsors and Collaborators

• University of South Dakota

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Patti Berg-Poppe, Associate Professor, University of South Dakota
• ClinicalTrials.gov Identifier: NCT04867876
• Other Study ID Numbers: QOL after UI treatment
• First Posted: Apr 30, 2021
• Last Update Posted: May 5, 2021
• Last Verified: Apr 1, 2021

• Keywords provided by Patti Berg-Poppe, Associate Professor, University of South Dakota: Quality of Life; Pediatric; Incontinence

Study Results

No Results Posted as of May 5, 2021