CBD for Lower Urinary Tract Dysfunction in Spinal Cord Injury
Cannabinoid Modulation for Neurogenic Lower Urinary Tract Dysfunction in Spinal Cord Injury
4 other identifiers
interventional
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2026
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2025
CompletedFirst Posted
Study publicly available on registry
February 21, 2025
CompletedStudy Start
First participant enrolled
February 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
March 4, 2026
March 1, 2026
1.2 years
February 17, 2025
March 2, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Adherence to CBD (Epidiolex) regimen
Participants will complete a daily smartphone application-based drug diary recording when they take study drug.
90 days
Completion of 72-hour voiding diary
This assessment involves electronic participant documentation of urinary episodes at home.
90 days
Number of adverse events
Participants will be followed for adverse events for at least 30 days after the last dose of study drug.
120 days
Secondary Outcomes (3)
Change in urinary incontinence (UI) episodes
Baseline to 90 days
Change in symptoms associated with UI
Baseline to 90 days
Change in urinary symptoms associated with neurogenic bladder
Baseline to 90 days
Other Outcomes (14)
Change in Urodynamics - bladder capacity
Baseline to 3 months
Change in Urodynamics - maximum detrusor pressure
Baseline to 3 months
Change in Urodynamics - bladder compliance
Baseline to 3 months
- +11 more other outcomes
Study Arms (1)
CBD for urinary incontinence
EXPERIMENTALParticipants will take CBD for 90 days
Interventions
Eligibility Criteria
You may qualify if:
- \>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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin - Madison
Madison, Wisconsin, 53705, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Javi Santiago
University of Wisconsin, Madison
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2025
First Posted
February 21, 2025
Study Start
February 13, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
March 4, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share