Incontinence and Quality of Life in Children With Spina Bifida

NCT03410667 | Active Not Recruiting DMC

• 2 other identifiers: 17072070635K23DK119368
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• SB-specific HRQOL

  The primary outcome, SB-specific HRQOL, will be evaluated using the validated 10-item QUAlity of Life ASsessment in Children/Teenagers (QUALAS-C/T) questionnaire. Scores range from 0 to 100, with higher scores signifying better HRQOL.

  2 years

Secondary Outcomes (3)

• Shared decision making

  2 years

• Patient-provider communication

  2 years

• UI Goal selection and attainement

  2 years

Study Arms (2)

Standard Care

OTHER

Standard of care arm

Behavioral: Phase One: Exploration; Behavioral: Phase Two: Creation; Behavioral: Phase Three: Reflection

Intervention Arm

EXPERIMENTAL

Intervention arm

Behavioral: Aim 3

Interventions

Phase One: Exploration BEHAVIORAL

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.

Standard Care

Phase Two: Creation BEHAVIORAL

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.

Standard Care

Phase Three: Reflection BEHAVIORAL

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.

Standard Care

Aim 3 BEHAVIORAL

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

Also known as: Prospective Assessment of Patient-Centered Goals and HRQOL

Intervention Arm

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Spina bifida
• years old
• Followed at Riley Hospital Pediatric Urology Outpatient Clinic
• Primary caregiver is patient's legal guardian
• Urinary incontinence in the past 4 weeks
• Fecal incontinence in the past 4 weeks
• Normal to mildly impaired cognitive development
• English language literacy
• Intent to receive care at the Riley Pediatric Urology Clinic for th extent of the study
• The physician panel will be composed of pediatric urologists.

You may not qualify if:

• Children with significant cognitive impairment, as they will not be able to express their urinary and fecal incontinence goals.
• Patients who underwent a genitourinary procedure or a bowel procedure in the past 4 weeks, since these patients are often temporarily catheterized and therefore not experiencing their typical level of urinary and fecal incontinence.

Sponsors & Collaborators

• Indiana University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

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Related Links

• Hasso Plattner Institute of Design. bootcamp bootleg Accessed March 24, 2015.

MeSH Terms

Conditions

Spinal Dysraphism; Meningomyelocele

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Urology

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: January 25, 2018
• Study Start: December 1, 2019
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)