CBD for Lower Urinary Tract Dysfunction in Spinal Cord Injury
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>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
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
CBD
DrugTwice daily 100mg cannabidiol (CBD)
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: CBD for urinary incontinenceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adherence to CBD (Epidiolex) regimen
Participants will complete a daily smartphone application-based drug diary recording when they take study drug.
Time frame
90 days2
Completion of 72-hour voiding diary
This assessment involves electronic participant documentation of urinary episodes at home.
Time frame
90 days3
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 daysSecondary outcomes
1
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 days2
Change in symptoms associated with UI
Measured on 72-hour voiding diary, participant documentation of urinary episodes at home.
Time frame
Baseline to 90 days3
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 daysOther outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov