Neurogenic Bladder Clinical Trial
Official title:
Leveraging Behavioral Economics to Promote Independent Clean Intermittent Catheterization in Children With Spina Bifida
Verified date | June 2024 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | April 18, 2024 |
Est. primary completion date | April 18, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 12 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Hospital | Durham | North Carolina |
United States | Lenox Baker Children's Hopsital | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Atchley TJ, Dangle PP, Hopson BD, Graham A, Arynchyna AA, Rocque BG, Joseph DB, Wilson TS. Age and factors associated with self-clean intermittent catheterization in patients with spina bifida. J Pediatr Rehabil Med. 2018;11(4):283-291. doi: 10.3233/PRM-170518. — View Citation
Edwards AB, Jacobs M. Early Vs. Expectant Management of Spina Bifida Patients-Are We All Talking About a Risk Stratified Approach? Curr Urol Rep. 2019 Nov 16;20(11):76. doi: 10.1007/s11934-019-0943-z. — View Citation
Hobbs KT, Krischak M, Tejwani R, Purves JT, Wiener JS, Routh JC. The Importance of Early Diagnosis and Management of Pediatric Neurogenic Bladder Dysfunction. Res Rep Urol. 2021 Sep 2;13:647-657. doi: 10.2147/RRU.S259307. eCollection 2021. — View Citation
Lapides J, Diokno AC, Silber SJ, Lowe BS. Clean, Intermittent Self-Catheterization in the Treatment of Urinary Tract Disease. J Urol. 2017 Feb;197(2S):S122-S124. doi: 10.1016/j.juro.2016.10.097. Epub 2016 Dec 21. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with independent CIC (Clean Intermittent Catheterization) | 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. | 3 months |
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