Spinal Cord Injury, Supra-sacral Spinal Cord Injury, Urinary Incontinence
Conditions
Brief summary
The goal of this feasibility study is to learn whether Cannabidiol (CBD) can improve urinary incontinence and other symptoms in people with recent spinal cord injury (SCI). Participants will take Epidiolex (purified CBD) for 90 days
Detailed description
This pilot study assesses the feasibility of using 100mg of twice daily cannabidiol (Epidiolex) in adult spinal cord injury with neurogenic lower urinary tract dysfunction following resolution of spinal shock.
Interventions
DRUGCBD
Twice daily 100mg cannabidiol (CBD)
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>18 years of age * History of supra-sacral spinal cord injury of any mechanism * Urinary incontinence with ≥2 episodes of urinary incontinence per day (outside of spinal shock) * Willingness to participate in drug intervention trial * English-speaking (able to provide consent and complete questionnaires)
Exclusion criteria
* History of intravesical Botox * Actively taking \>15 mg of Oxybutynin single dose or equivalent dose of alternative anticholinergic medication for bladder symptoms * Use of Cannabis (any form) outside of study as determined by urine drug screen after washout period of 1 month if prior Cannabis use reported * Thought or mood disorder aside from depression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to CBD (Epidiolex) regimen | 90 days | Participants will complete a daily smartphone application-based drug diary recording when they take study drug. |
| Completion of 72-hour voiding diary | 90 days | This assessment involves electronic participant documentation of urinary episodes at home. |
| Number of adverse events | 120 days | Participants will be followed for adverse events for at least 30 days after the last dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in urinary incontinence (UI) episodes | Baseline to 90 days | Measured in the 72-hour voiding diary, participant documentation of urinary episodes at home. |
| Change in symptoms associated with UI | Baseline to 90 days | Measured on 72-hour voiding diary, participant documentation of urinary episodes at home. |
| Change in urinary symptoms associated with neurogenic bladder | Baseline to 90 days | Measured using Neurogenic Bladder Symptom Score - Short Form (NGBSS-SF). NGBSS-SF is a 10 question survey assessing the following domains: bladder management strategy, incontinence, storage \& voiding, consequences, and quality of life. The total score ranges from 0 (no symptoms) to 28 (most severe symptoms). A higher total score indicates greater severity of neurogenic bladder symptoms. |
Countries
United States
Contacts
CONTACTMaria Flory
PRINCIPAL_INVESTIGATORJavi Santiago
University of Wisconsin, Madison
Outcome results
None listed