CBD for Lower Urinary Tract Dysfunction in Spinal Cord Injury

Participants will complete a daily smartphone application-based drug diary recording when they take study drug.

This assessment involves electronic participant documentation of urinary episodes at home.

Participants will be followed for adverse events for at least 30 days after the last dose of study drug.

Measured in the 72-hour voiding diary, participant documentation of urinary episodes at home.

Measured on 72-hour voiding diary, participant documentation of urinary episodes at home.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.