NCT04867876

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable quality-of-life

Timeline
Completed

Started May 2014

Typical duration for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
5.2 years until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
Last Updated

May 5, 2021

Status Verified

April 1, 2021

Enrollment Period

1.8 years

First QC Date

January 6, 2015

Last Update Submit

April 29, 2021

Conditions

Quality of LifeIncontinence

Keywords

Quality of LifePediatricIncontinence

Outcome Measures

Primary Outcomes (2)

  • Dysfunctional Voiding Symptom Scale

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

    3-6 months

  • Kid KINDL Questionnaire

    Quality of Life

    3-6 months

Study Arms (1)

Intervention Cohort

EXPERIMENTAL

Physical Therapy

Behavioral: Physical Therapy

Interventions

Physical TherapyBEHAVIORAL

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 Cohort

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Dakota

Vermillion, South Dakota, 57069, United States

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Patti J. Berg-Poppe, PhD

    University of South Dakota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 6, 2015

First Posted

April 30, 2021

Study Start

May 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

May 5, 2021

Record last verified: 2021-04

Locations

US(1)