CBD for Lower Urinary Tract Dysfunction in Spinal Cord Injury

NCT ID: NCT06840899

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2027-05-31

Brief Summary

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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

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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.

Conditions

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Supra-sacral Spinal Cord Injury Spinal Cord Injury Urinary Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBD for urinary incontinence

Participants will take CBD for 90 days

Group Type EXPERIMENTAL

CBD

Intervention Type DRUG

Twice daily 100mg cannabidiol (CBD)

Interventions

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CBD

Twice daily 100mg cannabidiol (CBD)

Intervention Type DRUG

Other Intervention Names

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Epidiolex

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Javi Santiago

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin - Madison

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Maria Flory

Role: CONTACT

608-262-8652

Facility Contacts

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Maria Flory

Role: primary

608-262-8652

Other Identifiers

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A539800

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/UROLOGY/UROLOGY

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 9/16/24

Identifier Type: OTHER

Identifier Source: secondary_id

2025-0012

Identifier Type: -

Identifier Source: org_study_id

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