CBD for Urinary Incontinence

Overseen By Maria Flory

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Wisconsin, Madison

Must not be taking: Cannabis, Anticholinergics

Disqualifiers: Intravesical Botox, Thought disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Cannabidiol (CBD) can reduce urinary incontinence in individuals who have recently experienced a spinal cord injury. Participants will take a form of purified CBD called Epidiolex for 90 days. The goal is to determine if CBD can improve bladder control and related symptoms. The study seeks individuals with a spinal cord injury who experience frequent urinary incontinence, defined as two or more accidents per day. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use cannabis outside of the study. If you have used cannabis before, there is a 1-month period without it before starting the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that Cannabidiol (CBD) has been used safely in many studies. One study involving people with multiple sclerosis (MS) found that a cannabis-based extract containing CBD was safe for treating urinary and other issues. Most people tolerate CBD well, though common side effects include dry mouth, diarrhea, reduced appetite, and drowsiness.

Notably, about half of the participants experienced side effects such as elevated liver enzyme levels, excessive drowsiness, and insomnia. Consider these factors when deciding whether to join a trial. Consulting a healthcare professional can help determine if this treatment is suitable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for urinary incontinence?

Unlike standard treatments for urinary incontinence, which often include medications like anticholinergics or lifestyle changes, Cannabidiol (CBD) offers a unique approach by harnessing the properties of a natural compound found in cannabis. Researchers are excited about CBD because it may provide relief without the common side effects associated with traditional medications, such as dry mouth or constipation. Additionally, CBD's potential anti-inflammatory and muscle-relaxing effects could address incontinence in a novel way, offering hope for those who haven’t found success with existing options.

What evidence suggests that this treatment might be an effective treatment for urinary incontinence?

Research has shown that cannabis-based treatments, such as cannabidiol (CBD), can help reduce urinary symptoms. In one study, participants experienced fewer episodes of urgency and incontinence after using CBD. Another study found that CBD decreased the number and size of incontinence episodes and reduced the frequency of urination. This trial will evaluate CBD for urinary incontinence, and these findings suggest that CBD might improve bladder control and reduce symptoms for individuals with urinary incontinence, particularly those who have recently sustained spinal cord injuries. ^{2 3 4 6 7}

Who Is on the Research Team?

Javi Santiago

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 with recent supra-sacral spinal cord injury causing urinary incontinence of at least two episodes per day. Participants must be willing to try a drug intervention but not use any cannabis outside the study or have certain mood disorders, and can't be on high doses of specific bladder medications.

Inclusion Criteria

Willingness to participate in drug intervention trial

English-speaking (able to provide consent and complete questionnaires)

I am older than 18 years.

Exclusion Criteria

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

Presence of thought or mood disorder aside from depression

I am taking more than 15 mg of Oxybutynin or a similar medication for bladder issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 100mg of Epidiolex (CBD) twice daily for 90 days

12 weeks

Participants complete a daily smartphone application-based drug diary

Follow-up

Participants are monitored for adverse events and changes in symptoms for 30 days after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol

Trial Overview The study tests if Cannabidiol (CBD), specifically Epidiolex, can help manage urinary incontinence and related symptoms in people with spinal cord injuries. Participants will take purified CBD for a duration of 90 days to assess its effectiveness.

How Is the Trial Designed?

Group I: CBD for urinary incontinence Experimental Treatment 1 Intervention

Participants will take CBD for 90 days

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Published Research Related to This Trial

The first clinical trial using autologous muscle-derived stem cells (AMDC) for treating underactive bladder (UAB) showed no adverse events, indicating that the treatment is safe.

After one year, while the patient still required self-catheterization, there was a notable reduction in maximum bladder capacity, suggesting that AMDC injections may improve bladder function in UAB patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intradetrusor injection of adult muscle-derived cells for the treatment of underactive bladder: pilot study. Levanovich, PE., Diokno, A., Hasenau, DL., et al.[2018]

Nearly 50% of CBD users experienced adverse drug events (ADEs), with common issues including elevated liver enzymes, sedation, and sleep disturbances, indicating a significant safety concern.

CBD has a high potential for drug-drug interactions (DDIs) due to its effects on drug metabolism, particularly with enzymes like CYP3A4 and CYP2C19, suggesting that careful monitoring and dose adjustments may be necessary for patients on multiple medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. Brown, JD., Winterstein, AG.[2020]

A systematic review of 4186 studies on cannabidiol (CBD) revealed that most research focuses on neurological outcomes, with significant adverse events reported in this area, highlighting the need for careful assessment of CBD's safety.

There is a notable gap in research regarding the reproductive and developmental toxicity of CBD, suggesting that future studies should prioritize these areas to establish safe intake levels for consumers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol Safety Data: A Systematic Mapping Study. Henderson, RG., Franke, KS., Payne, LE., et al.[2023]

Serious suspected adverse reactions (SARs) to unlicensed cannabidiol (CBD) products were found to be 18.9% of all adverse events, with a higher frequency in men and adults, indicating a need for careful monitoring of its use.

The most common adverse effects associated with unlicensed CBD included mental disorders, hepatic disorders, and worsening of pre-existing epilepsy, particularly in patients also taking antiepileptic medications like clobazam and valproic acid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacovigilance of unlicensed cannabidiol in European countries. Calapai, F., Esposito, E., Ammendolia, I., et al.[2023]

A systematic review of 12 clinical trials involving 803 participants found that cannabidiol (CBD) is associated with a higher likelihood of withdrawal due to adverse effects compared to placebo, particularly in studies related to childhood epilepsy.

While CBD generally appears well tolerated, significant adverse effects such as abnormal liver function tests and sedation were noted, especially in combination with other medications, highlighting the need for careful monitoring of drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials. Chesney, E., Oliver, D., Green, A., et al.[2021]

OnabotulinumtoxinA (BoNT-A) injections significantly improved lower urinary tract symptoms (LUTS) in 30 men with primary bladder-neck dysfunction, with total symptom scores decreasing from 21.9 at baseline to 7.8 at 2 months, indicating effective symptom relief.

The treatment was found to be safe, with no significant adverse effects or ejaculatory dysfunction reported, although the benefits appeared to diminish over time, suggesting the need for repeated injections for sustained improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OnabotulinumtoxinA injection therapy in men with LUTS due to primary bladder-neck dysfunction: objective and patient-reported outcomes. Sacco, E., Tienforti, D., Bientinesi, R., et al.[2018]

Cannabidiol (CBD) has been associated with significant adverse events, particularly 'weight decreased', 'hypophagia', and 'insomnia', based on a disproportionality analysis of reports from the VigiBase® database involving various patients.

The interaction of CBD with the serotonin 5-HT1A receptor may explain the occurrence of insomnia, highlighting the need for careful monitoring of these side effects in patients using CBD for conditions like Lennox-Gastaut syndrome and Dravet syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological Evaluation of Signals of Disproportionality Reporting Related to Adverse Reactions to Antiepileptic Cannabidiol in VigiBase. Calapai, F., Mannucci, C., McQuain, L., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15327041/

An open-label pilot study of cannabis-based extracts for ... Urinary urgency, the number and volume of incontinence episodes, frequency and nocturia all decreased significantly following treatment (P <0.05, Wilcoxon's ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06840899

CBD for Lower Urinary Tract Dysfunction in Spinal Cord ... The goal of this feasibility study is to learn whether Cannabidiol (CBD) can improve urinary incontinence and other symptoms in people with recent spinal ...

3. withpower.com withpower.com/trial/phase-2-wounds-and-injuries-2-2025-b8291

CBD for Urinary Incontinence Research shows that cannabis-based treatments, including those with cannabidiol (CBD), have been effective in reducing urinary symptoms like urgency and ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429510020789

Inhibitory Effect of Standardized Cannabis sativa Extract ... Cannabis based-medicines, including CBD-enriched extracts, have been shown to reduce urinary urgency, incontinence episodes, frequency, and nocturia in patients ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2878434/

Functional role of cannabinoid receptors in urinary bladder Significant reduction in urge incontinence episodes and improvement in bladder control from baseline were noted at the end of the study with the use of cannabis ...

6. projectcbd.org projectcbd.org/health/cannabis-for-incontinence/

Cannabis & Incontinence Thanks to ongoing research on cannabis and MS, quite a bit of useful data about incontinence has been collected, both in preclinical studies and ...

7. mayoclinic.org mayoclinic.org/healthy-lifestyle/consumer-health/expert-answers/is-cbd-safe-and-effective/faq-20446700

CBD: Safe and effective? CBD use also carries some risks. Though it's often well-tolerated, CBD can cause side effects, such as dry mouth, diarrhea, reduced appetite, drowsiness and ...