~8 spots leftby Jan 2026

Incontinence Management Tool for Spina Bifida

Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Indiana University
No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Patients with spina bifida
English language literacy
Intent to receive care at the Riley Pediatric Urology Clinic for the extent of the study
See 6 more

Exclusion Criteria

I had a surgery related to my urinary or bowel system in the last 4 weeks.
My child does not have significant cognitive issues affecting communication.

Treatment Details

Interventions

  • Aim 2 (Behavioural Intervention)
  • Phase One: Exploration (Behavioural Intervention)
  • Phase Three: Reflection (Behavioural Intervention)
  • Phase Two: Creation (Behavioural Intervention)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Standard CareExperimental Treatment3 Interventions
Standard of care arm
Group II: Intervention ArmExperimental Treatment1 Intervention
Intervention arm

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Riley Hospital for ChildrenIndianapolis, IN
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Who Is Running the Clinical Trial?

Indiana UniversityLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator

References