Supra-sacral Spinal Cord InjuryPhase 2NCT06840899
CBD for Lower Urinary Tract Dysfunction in Spinal Cord Injury
A Phase 2 study testing CBD in people with Supra-sacral Spinal Cord Injury and Spinal Cord Injury, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supra-sacral Spinal Cord Injury, Spinal Cord Injury, Urinary Incontinence
- What is being tested?
- CBD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2026to May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin - Madison
Madison, Wisconsin, 53705
Maria Flory, 608-262-8652, flory@ortho.wisc.edu
About this study
Official title: Cannabinoid Modulation for Neurogenic Lower Urinary Tract Dysfunction in Spinal Cord Injury
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
Read the 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.
- Being tested
- CBD
- Medical subject headings
- Spinal Cord Injuries, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBDDrug
Also called Epidiolex
Twice daily 100mg cannabidiol (CBD)
| Study group | Role | What they receive |
|---|---|---|
| CBD for urinary incontinence | Experimental | Participants will take CBD for 90 days Receives: Drug: CBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to CBD (Epidiolex) regimen
Participants will complete a daily smartphone application-based drug diary recording when they take study drug.
Measured: 90 days
Completion of 72-hour voiding diary
This assessment involves electronic participant documentation of urinary episodes at home.
Measured: 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.
Measured: 120 days
Secondary outcomes (3)
Change in urinary incontinence (UI) episodes
Measured in the 72-hour voiding diary, participant documentation of urinary episodes at home.
Measured: Baseline to 90 days
Change in symptoms associated with UI
Measured on 72-hour voiding diary, participant documentation of urinary episodes at home.
Measured: Baseline to 90 days
Change in urinary symptoms associated with neurogenic bladder
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.
Measured: Baseline to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start13 Feb 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supra-sacral Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javi Santiago, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840899
- Sponsor's protocol ID
- 2025-0012
- Other IDs
- A539800, SMPH/UROLOGY/UROLOGY, Protocol Version 2/18/26
- Status last verified
- Sep 2026
- First submitted
- 17 Feb 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabinoid Modulation for Neurogenic Lower Urinary Tract Dysfunction in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06840899
- Acronym / sponsor ID
- 2025-0012
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBD for urinary incontinence | Experimental | Drug: CBDParticipants will take CBD for 90 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBDAlso: EpidiolexTwice daily 100mg cannabidiol (CBD) | Drug | CBD for urinary incontinence |
Primary outcome
Adherence to CBD (Epidiolex) regimen
Time frame: 90 days
Participants will complete a daily smartphone application-based drug diary recording when they take study drug.
Completion of 72-hour voiding diary
Time frame: 90 days
This assessment involves electronic participant documentation of urinary episodes at home.
Number of adverse events
Time frame: 120 days
Participants will be followed for adverse events for at least 30 days after the last dose of study drug.
3 secondary outcomes
Change in urinary incontinence (UI) episodes
Time frame: Baseline to 90 days
Change in symptoms associated with UI
Time frame: Baseline to 90 days
Change in urinary symptoms associated with neurogenic bladder
Time frame: Baseline to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Javi Santiago principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CBD in people with Supra-sacral Spinal Cord Injury and Spinal Cord Injury, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Flory (608-262-8652, flory@ortho.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to CBD (Epidiolex) regimen (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.