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New tool lets kids with spina bifida choose their own incontinence goals

NCT ID NCT03410667

Knowledge-focused Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is creating a new tool for children with spina bifida and their doctors to work together on setting personal goals for managing bladder and bowel leakage. The goal is to improve the child's quality of life by focusing on what matters most to them, rather than just medical targets. About 67 children aged 8-17 will use the tool during their clinic visits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

67 people

The number who actually took part.

Started

Dec 2019

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

8 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Spina bifida * 8-17 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

myelomeningocele spina bifida

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myelomeningocele Spina bifida

Contacts and locations

Locations

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.