CBD for Lower Urinary Tract Dysfunction in Spinal Cord Injury

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

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence; Spinal Cord Injury; Supra-sacral Spinal Cord Injury
• Intervention / Treatment: Drug: CBD

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Maria Flory; Phone Number: 608-262-8652; Email: flory@ortho.wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Recruiting
      • University of Wisconsin - Madison
      • Contact: Maria Flory; Phone Number: 608-262-8652; Email: flory@ortho.wisc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• >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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBD for urinary incontinence; Participants will take CBD for 90 days	Drug: CBD; Twice daily 100mg cannabidiol (CBD); Other Names: Epidiolex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in urinary incontinence (UI) episodes	Measured in the 72-hour voiding diary, participant documentation of urinary episodes at home.	Baseline to 90 days
Change in symptoms associated with UI	Measured on 72-hour voiding diary, participant documentation of urinary episodes at home.	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.	Baseline to 90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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	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.	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.	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.	Baseline, 3 months, and 4 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Javi Santiago, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): February 21, 2025

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Trauma, Nervous System; Spinal Cord Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence; Spinal Cord Injuries; Organic Chemicals; Hydrocarbons; Terpenes; Cannabinoids; Cannabidiol
• Other Study ID Numbers: 2025-0012; A539800 (Other Identifier: UW Madison); SMPH/UROLOGY/UROLOGY (Other Identifier: UW Madison); Protocol Version 2/18/26 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No