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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05562713
Other study ID # Pro00111134
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date April 18, 2024

Study information

Verified date June 2024
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
Present Bias without Loss Aversion
Small prize for each step completed; large prize for independent CIC
Present Bias with Loss Aversion
Prizes only if fully independent CIC demonstrated

Locations

Country Name City State
United States Duke University Hospital Durham North Carolina
United States Lenox Baker Children's Hopsital Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

Outcome

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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