Neurogenic Bladder, Spina Bifida
Conditions
Keywords
clean intermittent catheterization, spina bifida, neurogenic bladder, behavioral economics
Brief 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.
Detailed description
There are three study arms to which patients will be randomized in block randomization fashion with goal recruitment totaling 45 patients. Randomization will begin with Arm 1 and Arm 2 in a 1:1 ratio for the first 20 patients, 10 patients per arm. If accrual is reasonably brisk, we will expand our recruitment to Arm 3 which will then be conducted in a 1:1:3 block randomization for the remaining 25 patients with a total of 15 patients per arm. If accrual is slow and recruitment goal will not be met by expected date, we will continue accrual to Arm 1 and Arm 2 without including Arm 3. Randomization will be performed via NIH clinical trial randomization tool.
Interventions
BEHAVIORALPresent Bias without Loss Aversion
Small prize for each step completed; large prize for independent CIC
BEHAVIORALPresent Bias with Loss Aversion
Prizes only if fully independent CIC demonstrated
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of spina bifida, including meningocele and myelomeningocele, as defined by International Classification of Diseases, 10th revision (ICD10). ICD-10 codes will include Q05.0-Q05.9 * 4-12 years old * CIC performed fully by their caregiver * Demonstrate manual dexterity to perform CIC (determined by the patient's caregiver and the pediatric urologist in clinic) * Communication in English language
Exclusion criteria
* non-English speaking patients * less than 4 years old; older than 12 years of age * non-spina bifida patients * already perform independent or semi-independent CIC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with independent CIC (Clean Intermittent Catheterization) | 3 months | 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 defined as less than 20% of the age-appropriate bladder volume. |
Countries
United States
Outcome results
None listed