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Incontinence Management Tool for Spina Bifida

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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I have experienced urinary incontinence in the last month.

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I have experienced loss of bowel control in the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

SB-specific HRQOL

Secondary outcome measures

Patient-provider communication

Shared decision making

UI Goal selection and attainement

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard CareExperimental Treatment3 Interventions

Standard of care arm

Group II: Intervention ArmExperimental Treatment1 Intervention

Intervention arm

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

981,401 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,192 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate size of participants in this experiment?

"Affirmative. The clinical trial is actively searching for participants, according to the data on clinicaltrials.gov. This medical study was posted in December 2019 and edited lastly in October 2022. 400 patients are needed from 1 research facility."

Answered by AI

Are there presently any openings to participate in this experiment?

"Affirmative. Clinical trials data on the government website suggests that this research is currently in need of participants, with an initial posting date of December 1st 2019 and a most recent update issued October 25th 2022. The study requires 400 individuals from one location to complete it."

Answered by AI