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NCT05562713 · ClinicalTrials.gov registry record · NA

CIC Behavioral Economics in Children With Spina Bifida

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
22
Enrollment target

NCT05562713: Completed NA study, sponsored by Duke University.

NCT05562713 is a NA study that has completed, run by Duke University. The registered enrollment target is 22 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05562713, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
22 participants
Enrollment target

Study Summary

The purpose of the study is to develop a comprehensive program to increase early initiation of self-catheterization in children with Spina Bifida. This will be a prospective open label randomized control trial. Patients and caregivers/guardians in the intervention arm will be enrolled in a comprehensive program that utilizes behavioral economic theory to incentivize initiation of independent CIC. The study population will be patients aged 4 to 12 years old with diagnosis of spina bifida, including meningocele and myelomeningocele, as defined by International Classification of Diseases, 10th revision (ICD10). This study will look at behavioral interventions. There are no additional physical risks to participation in the study. Patient demographics will be reported using descriptive statistics. Study team will use Kaplan-Meier curves to demonstrate and compare the probability of achieving independent CIC over time between the study arms.

Primary Outcome

Upon notification from the caregiver that a child is ready to demonstrate self-CIC, they will come to the Duke Pediatric Urology or Duke Spina Bifida Clinic and meet with study personnel. Participating children will be given supplies and asked to perform CIC in private. Prior to CIC, they will have a bladder scan to measure the pre-CIC bladder volume. After they perform CIC, another bladder scan will be performed to evaluate the post-CIC bladder volume. An adequate post-CIC volume will be define

Interventions

  • BEHAVIORAL Present Bias without Loss Aversion
  • BEHAVIORAL Present Bias with Loss Aversion

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2023-08-01
Est. Completion 2024-04-18
Phase NA
Duke University

1,725 total trials

What the finished NCT05562713 record still lists

NCT05562713 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Present Bias without Loss Aversion is the first listed.

NCT05562713 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05562713 about?

NCT05562713 is a clinical study titled "CIC Behavioral Economics in Children With Spina Bifida". The purpose of the study is to develop a comprehensive program to increase early initiation of self-catheterization in children with Spina Bifida. This will be a prospective open label randomized control trial. Patients and caregivers/guardians in the intervention arm will be enrolled in a comprehe...

What is the current status of trial NCT05562713?

This trial is currently completed. It is a NA study. The enrollment target is 22 participants. The study started on 2023-08-01. Estimated completion is 2024-04-18.

What interventions are being tested in trial NCT05562713?

The interventions under investigation include: Present Bias without Loss Aversion (BEHAVIORAL), Present Bias with Loss Aversion (BEHAVIORAL).

Who is sponsoring clinical trial NCT05562713?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05562713's enrollment target sits among peer trials

22 1756th of 2000 higher than 239 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05562713, the US trial registry maintained by the National Library of Medicine. NCT05562713 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.