Qol Following Management for Pediatric UI

NCT ID: NCT04867876

Last Updated: 2021-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Quality of Life Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention Cohort

Physical Therapy

Group Type EXPERIMENTAL

Physical Therapy

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of South Dakota

OTHER

Sponsor Role lead

Responsible Party

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Patti Berg-Poppe

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patti J. Berg-Poppe, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Dakota

Locations

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University of South Dakota

Vermillion, South Dakota, United States

Site Status

Countries

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United States

Other Identifiers

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QOL after UI treatment

Identifier Type: -

Identifier Source: org_study_id

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