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Incontinence Management Tool for Spina Bifida

N/A
Waitlist Available
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 8-17 years old
Urinary incontinence in the past 4 weeks
Must not have
Children with significant cognitive impairment, as they will not be able to express their urinary and fecal incontinence goals
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new tool to help spina bifida patients and their urologists work together to identify goals for treating urinary and fecal incontinence. The tool will help patients communicate their symptoms and what they hope to achieve, so that the most appropriate treatment can be determined.

Who is the study for?
This trial is for children aged 8-17 with spina bifida who experience urinary and fecal incontinence, are followed at Riley Hospital Pediatric Urology Clinic, have a legal guardian as their primary caregiver, possess normal to mildly impaired cognitive development, can read English, and plan to receive care at the clinic throughout the study. It excludes those with significant cognitive impairment or recent genitourinary/bowel procedures.
What is being tested?
The trial is developing an interactive tool that helps children with spina bifida and their urologists set personal goals for managing urinary and fecal incontinence. This tool aims to shift focus from traditional clinical targets to personalized patient experiences and quality of life improvements.
What are the potential side effects?
Since this trial involves the use of an interactive goal-setting tool rather than medication or invasive treatments, there are no direct medical side effects associated with its use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 8 and 17 years old.
Select...
I have experienced urinary incontinence in the last month.
Select...
I have experienced loss of bowel control in the last month.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My child does not have significant cognitive issues affecting communication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
SB-specific HRQOL
Secondary study objectives
Patient-provider communication
Shared decision making
UI Goal selection and attainement

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard CareExperimental Treatment3 Interventions
Standard of care arm
Group II: Intervention ArmExperimental Treatment1 Intervention
Intervention arm

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,039 Previous Clinical Trials
1,218,991 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,446 Previous Clinical Trials
4,331,765 Total Patients Enrolled
2 Trials studying Spina Bifida
465 Patients Enrolled for Spina Bifida

Media Library

Aim 2 Clinical Trial Eligibility Overview. Trial Name: NCT03410667 — N/A
Spina Bifida Research Study Groups: Intervention Arm, Standard Care
Spina Bifida Clinical Trial 2023: Aim 2 Highlights & Side Effects. Trial Name: NCT03410667 — N/A
Aim 2 2023 Treatment Timeline for Medical Study. Trial Name: NCT03410667 — N/A
~1 spots leftby Dec 2024
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