CBD for Lower Urinary Tract Dysfunction in Spinal Cord Injury

Phase 2

Recruiting

• Conditions: Supra-sacral Spinal Cord Injury; Spinal Cord Injury; Urinary Incontinence
• Interventions: Drug: CBD

• Registration Number: NCT06840899
• Lead Sponsor: University of Wisconsin, Madison

Brief 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

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 Timeline

• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-17
• Study First Posted: 2025-02-21
• Status Verified: 2025-06
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-23
• Study Start: 2025-08-01
• Primary Completion: 2027-02
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CBD for urinary incontinence	CBD	Participants will take CBD for 90 days

Primary Outcome Measures

Name	Time	Method
Adherence to CBD (Epidiolex) regimen	90 days	Participants will complete a daily smartphone application-based drug diary recording when they take study drug.
Completion of 72-hour voiding diary	90 days	This assessment involves electronic participant documentation of urinary episodes at home.
Number of adverse events	120 days	Participants will be followed for adverse events for at least 30 days after the last dose of study drug.

Secondary Outcome Measures

Name	Time	Method
Change in urinary incontinence (UI) episodes	Baseline to 90 days	Measured in the 72-hour voiding diary, participant documentation of urinary episodes at home.
Change in symptoms associated with UI	Baseline to 90 days	Measured on 72-hour voiding diary, participant documentation of urinary episodes at home.
Change in urinary symptoms associated with neurogenic bladder	Baseline to 90 days	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.

Trial Locations

Locations (1)

University of Wisconsin - Madison; 🇺🇸 Madison, Wisconsin, United States