Clinical trial NCT06840899: CBD for Lower Urinary Tract Dysfunction in Spinal Cord Injury
Official title: Cannabinoid Modulation for Neurogenic Lower Urinary Tract Dysfunction in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Supra-sacral Spinal Cord Injury
Spinal Cord Injury
Urinary Incontinence
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to CBD (Epidiolex) regimen
timeFrame: 90 days
measure: Completion of 72-hour voiding diary
timeFrame: 90 days
measure: Number of adverse events
timeFrame: 120 days
Secondary outcomes:
measure: Change in urinary incontinence (UI) episodes
timeFrame: Baseline to 90 days
measure: Change in symptoms associated with UI
timeFrame: Baseline to 90 days
measure: Change in urinary symptoms associated with neurogenic bladder
timeFrame: Baseline to 90 days
Other outcomes:
measure: Change in Urodynamics - bladder capacity
timeFrame: Baseline to 3 months
measure: Change in Urodynamics - maximum detrusor pressure
timeFrame: Baseline to 3 months
measure: Change in Urodynamics - bladder compliance
timeFrame: Baseline to 3 months
measure: Change in Urodynamics - neurogenic detrusor overactivity (NDO) episodes
timeFrame: Baseline to 3 months
measure: Change in Urodynamics - urine leaks
timeFrame: Baseline to 3 months
measure: Change in Urodynamics - vesicoureteral reflux
timeFrame: Baseline to 3 months
measure: Change in Urodynamics - bladder neck appearance
timeFrame: Baseline to 3 months
measure: Change in Urodynamics - bladder shape
timeFrame: Baseline to 3 months
measure: Change in Urodynamics - presence of detrusor sphincter dyssynergia
timeFrame: Baseline to 3 months
measure: Change in Brief Pain Inventory (BPI)
timeFrame: Baseline to 3 months
measure: Change in Neurogenic Bowel Dysfunction Score (NBD)
timeFrame: Baseline to 3 months
measure: Change in Pittsburgh Sleep Quality Index (PSQI) Questionnaire
timeFrame: Baseline to 3 months
measure: Patient Global Impression Scale (PGI-C)
timeFrame: 3 months
measure: Change in International Spinal Cord Injury Quality of Life Basic Data Set (SCI QOL)
timeFrame: Baseline, 3 months, and 4 months
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Javi Santiago
role: PRINCIPAL_INVESTIGATOR
References: