CBD for Lower Urinary Tract Dysfunction in Spinal Cord Injury

Phase 2RecruitingNCT06840899

University of Wisconsin, Madison20 enrolled

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Supra-sacral Spinal Cord Injury Spinal Cord Injury Urinary Incontinence

Interventions

CBDDRUG

Twice daily 100mg cannabidiol (CBD)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Wisconsin - Madison

Madison, Wisconsin, United States

RECRUITING

Outcomes

Primary Outcomes

Adherence to CBD (Epidiolex) regimen

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

Time frame: 90 days

Completion of 72-hour voiding diary

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

Time frame: 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.

Time frame: 120 days

Secondary Outcomes

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 days

Change in symptoms associated with UI

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

Time frame: 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.

Time frame: Baseline to 90 days

Central Contacts

Maria Flory

CONTACT

608-262-8652 flory@ortho.wisc.edu

Data from ClinicalTrials.gov

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