Incontinence and Quality of Life in Children With Spina Bifida

Summary

This study aims to develop an innovative, interactive tool for joint use by spina bifida patients and their urologists to identify patients interested in addressing their urinary and fecal incontinence and establish continence goal(s) they would like to achieve. To date, no such tool exists for use by spina bifida patients or urologists. This represents a major paradigm shift in the urologic care of pediatric SB patients. It will give children and families a voice in setting their personal goals for urinary and fecal incontinence, rather than relying on physicians' traditional clinical targets (e.g., absence of urinary incontinence, 4-hour dry interval). These traditional views fail to reflect the full patient experience of their ailment by underestimating symptoms and prioritizing only the most severe. This study represents the first time that such a process will be formalized before initiating urological therapy in children with SB (Aim 2). Additionally, this tool may help rule out interventions with a low chance of achieving desired goals and allow for a recalibration of unrealistic goals. The app will be useful for any child, regardless of urinary and fecal incontinence treatment history or underlying bladder pathology, as it will help describe personalized clinical treatment goals based on urinary incontinence, a characteristic all these patients share. This study will also capture the health-related quality of life (HRQOL) impact of urinary and fecal incontinence improvement regardless of the treatment, whether behavioral, medical or surgical, many of which are available to patients regardless of age. A systematic therapeutic goal-setting tool will help in bringing precision medicine to the SB population.

Conditions

• Spina Bifida
• Myelomeningocele

Interventions

BEHAVIORAL

Phase One: Exploration

Spina Bifida patients from the pediatric urology clinic at Riley Hospital and their caregivers will participate in discussions of UI goals. These patients will self report their experiences and perspectives using a "Day in the Life" diary tool-kit.

BEHAVIORAL

Phase Two: Creation

Patients, caregivers and providers will work to create a goal setting tool to help patients and physicians appropriately address the issue of UI in patients with spina bifida.

BEHAVIORAL

Phase Three: Reflection

This is a validation step to test whether the goal-setting tool is widely applicable and functional in a clinic setting. There will be cognitive interviews after the tool is completed to gather patient impressions.

BEHAVIORAL

Aim 3

This will be a large scale validation of the app, with assignment to standard care for the first year of enrollment.

Sponsors & Collaborators

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

  collaborator NIH

• Indiana University

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-01

Primary Completion

2026-03-15

Completion

2026-03-15

Countries

• United States

Study Locations