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Recruiting NCT06840899

CBD for Lower Urinary Tract Dysfunction in Spinal Cord Injury

Phase II Interventional Supra-sacral Spinal Cord Injury Spinal Cord Injury Urinary Incontinence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CBD.
Who it may be relevant to
Registry conditions: Supra-sacral Spinal Cord Injury, Spinal Cord Injury, Urinary Incontinence. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Cannabinoid Modulation for Neurogenic Lower Urinary Tract Dysfunction in Spinal Cord Injury

Overview

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.

Interventions

  • Drug CBD
    Twice daily 100mg cannabidiol (CBD)

Primary outcome measures

  • Adherence to CBD (Epidiolex) regimen [Time frame: 90 days]
  • Completion of 72-hour voiding diary [Time frame: 90 days]
  • Number of adverse events [Time frame: 120 days]
Secondary outcome measures (3)
  • Change in urinary incontinence (UI) episodes [Time frame: Baseline to 90 days]
  • Change in symptoms associated with UI [Time frame: Baseline to 90 days]
  • Change in urinary symptoms associated with neurogenic bladder [Time frame: Baseline to 90 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Wisconsin - Madison — Madison

Identifiers

NCT: NCT06840899 · 2025-0012 · A539800 · SMPH/UROLOGY/UROLOGY · Protocol Version 2/18/26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗