A Phase 2 interventional study of CBD in Supra-sacral Spinal Cord Injury, Spinal Cord Injury and Urinary Incontinence, sponsored by University of Wisconsin, Madison. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by University of Wisconsin, Madison · Phase 2, Interventional, and Treatment
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
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.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 20 is below the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will take CBD for 90 days
Drug: CBD
Twice daily 100mg cannabidiol (CBD)
Also known as: Epidiolex
Adherence to CBD (Epidiolex) regimen
Participants will complete a daily smartphone application-based drug diary recording when they take study drug.
Time frame: 90 days
Completion of 72-hour voiding diary
This assessment involves electronic participant documentation of urinary episodes at home.
Time frame: 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.
Time frame: 120 days
Change in urinary incontinence (UI) episodes
Measured in the 72-hour voiding diary, participant documentation of urinary episodes at home.
Time frame: Baseline to 90 days
Change in symptoms associated with UI
Measured on 72-hour voiding diary, participant documentation of urinary episodes at home.
Time frame: 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.
Time frame: Baseline to 90 days
Change in Urodynamics - bladder capacity
Bladder capacity assessment will be performed using pressure sensing urinary and rectal catheters during bladder filling with a solution of saline and iodinated contrast (and emptying if able) with fluoroscopic assessment. This assessment will only be completed for the first 10 participants to complete 3 months of treatment.
Time frame: Baseline to 3 months
Change in Urodynamics - maximum detrusor pressure
Max detrusor pressure assessment (cm H20) during bladder storage will be performed using pressure sensing urinary and rectal catheters during bladder filling with a solution of saline and iodinated contrast with fluoroscopic assessment. This assessment will only be completed for the first 10 participants to complete 3 months of treatment.
Time frame: Baseline to 3 months
Change in Urodynamics - bladder compliance
Bladder compliance assessment (mL/cm H20) will be performed using pressure sensing urinary and rectal catheters during bladder filling with a solution of saline and iodinated contrast (and emptying if able) with fluoroscopic assessment. This assessment will only be completed for the first 10 participants to complete 3 months of treatment.
Time frame: Baseline to 3 months
Change in Urodynamics - neurogenic detrusor overactivity (NDO) episodes
NDO episode (involuntary, sudden contractions of the bladder muscle leading to a strong urge to urinate and potentially causing urine leakage) assessment will be performed using pressure sensing urinary and rectal catheters during bladder filling with a solution of saline and iodinated contrast with fluoroscopic assessment. This assessment will only be completed for the first 10 participants to complete 3 months of treatment.
Time frame: Baseline to 3 months
Change in Urodynamics - urine leaks
Urine leak assessment will be performed using fluoroscopy during bladder filling with a solution of saline and iodinated contrast. This assessment will only be completed for the first 10 participants to complete 3 months of treatment.
Time frame: Baseline to 3 months
Change in Urodynamics - vesicoureteral reflux
Vesicoureteral reflux assessment will be performed using fluoroscopy during bladder filling with a solution of saline and iodinated contrast. This assessment will only be completed for the first 10 participants to complete 3 months of treatment.
Time frame: Baseline to 3 months
Change in Urodynamics - bladder neck appearance
Bladder neck appearance assessment will be performed using fluoroscopic assessment during bladder filling with a solution of saline and iodinated contrast (and emptying or leak if present). This assessment will only be completed for the first 10 participants to complete 3 months of treatment.
Time frame: Baseline to 3 months
Change in Urodynamics - bladder shape
Bladder shape assessment will be performed using fluoroscopy during bladder filling with a solution of saline and iodinated contrast. This assessment will only be completed for the first 10 participants to complete 3 months of treatment.
Time frame: Baseline to 3 months
Change in Urodynamics - presence of detrusor sphincter dyssynergia
Presence of detrusor sphincter dyssynergia assessment will be performed using pressure sensing urinary and rectal catheters, electromyography, and fluoroscopy during bladder filling with a solution of saline and iodinated contrast (and emptying or leaking if present). This assessment will only be completed for the first 10 participants to complete 3 months of treatment.
Time frame: Baseline to 3 months
Change in Brief Pain Inventory (BPI)
BPI is a 9 item survey assessing pain severity and impact on quality of life. Participants rate their pain on a scale of 0 to 10, where 10 is the worst pain imaginable. Participants also rate how much the pain interferes with their daily life on a scale of 0 to 10, where 10 is complete interference. Total combined range is 1-10, where pain severity and interference are: Mild: A score of 1-4; Moderate: A score of 5-6; and, Severe: A score of 7-10.
Time frame: Baseline to 3 months
Change in Neurogenic Bowel Dysfunction Score (NBD)
NBD is a 10 item system used to assess the severity of bowel dysfunction in individuals with neurological conditions, typically caused by spinal cord injuries, by assigning points based on the frequency and severity of symptoms like bowel movements, incontinence, and discomfort during defecation; a higher score indicates more severe neurogenic bowel dysfunction. The 10-items are scored on an ordinal scale. The NBD weighted score ranges between 0 and 47 points. A higher overall NBD score indicates more severe bowel symptoms. Score 0-6: Very minor; Score 7-9: Minor; Score 10-13: Moderate; and, Score 14+: Severe
Time frame: Baseline to 3 months
Change in Pittsburgh Sleep Quality Index (PSQI) Questionnaire
PSQI is a 19 item questionnaire assessing quality of sleep. Each component score ranges from 0 to 3, with 3 indicating the most disturbance. Total score is a number between 0 and 21 that indicates how well someone sleeps. A higher score means worse sleep quality.
Time frame: Baseline to 3 months
Patient Global Impression Scale (PGI-C)
The PGI-C is a single question survey assessing change in overall clinical status after intervention. Answers range from Very much improved to Very much worse.
Time frame: 3 months
Change in International Spinal Cord Injury Quality of Life Basic Data Set (SCI QOL)
The SCI QOL is a 3-item questionnaire to assess quality of life after spinal cord injury. It is scored on a 10 point Likert scale, with an overall range of 0-30. Lower scores indicate lower satisfaction with quality of life.
Time frame: Baseline, 3 months, and 4 months
Plan to share: Yes
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for May 2028, 27 months after the start.
Of 44 non-industry phase 2 interventional studies under Spinal Cord Injuries, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 64. This study's planned 27 months is below that.
Counting every sponsor, half of 49 studies reached it within 46 months; a quarter within 28 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Cannabidiol
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