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

Trial Summary

What is the purpose of this trial?

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

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.

What data supports the effectiveness of the drug Cannabidiol for urinary incontinence?

Research shows that cannabis-based treatments, including those with cannabidiol (CBD), have been effective in reducing urinary symptoms like urgency and incontinence in patients with multiple sclerosis. This suggests that CBD might help with urinary incontinence by targeting similar symptoms. ^{1 2 3 4 5}

Is CBD generally safe for human use?

CBD is generally well tolerated in humans, but it can cause some side effects like sleep disturbances, sedation, and changes in liver function. It may also interact with other medications, so it's important to monitor for any adverse effects, especially if you are taking other drugs. ^{6 7 8 9 10}

How does the drug Cannabidiol (CBD) differ from other treatments for urinary incontinence?

Cannabidiol (CBD) is unique because it is derived from cannabis and may offer a novel mechanism of action compared to traditional drugs like antimuscarinics and anticholinergics, which are the main FDA-approved options for urge incontinence. Unlike these drugs, CBD is not yet a standard treatment for urinary incontinence, and its potential benefits and side effects are still under investigation. ^{11 12 13 14 15}

Research Team

Javi Santiago

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

An open-label pilot study of cannabis-based extracts for bladder dysfunction in advanced multiple sclerosis. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Inhibitory effect of standardized cannabis sativa extract and its ingredient cannabidiol on rat and human bladder contractility. [2014]

3. Italy pubmed.ncbi.nlm.nih.gov

THC/CBD oromucosal spray in patients with multiple sclerosis overactive bladder: a pilot prospective study. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Cannabinor, a selective cannabinoid-2 receptor agonist, improves bladder emptying in rats with partial urethral obstruction. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Cannabinoids for treating neurogenic lower urinary tract dysfunction in patients with multiple sclerosis: a systematic review and meta-analysis. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol Safety Data: A Systematic Mapping Study. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacological Evaluation of Signals of Disproportionality Reporting Related to Adverse Reactions to Antiepileptic Cannabidiol in VigiBase. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Pharmacovigilance of unlicensed cannabidiol in European countries. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Intradetrusor injection of adult muscle-derived cells for the treatment of underactive bladder: pilot study. [2018]

12. Spain pubmed.ncbi.nlm.nih.gov

OnabotulinumtoxinA in urinary incontinence: Prospective Study of a Case Series. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Medical management of urinary incontinence. [2019]

14. Germany pubmed.ncbi.nlm.nih.gov

Effects of β3-adrenoceptor agonist on acute urinary retention in a rat model. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

OnabotulinumtoxinA injection therapy in men with LUTS due to primary bladder-neck dysfunction: objective and patient-reported outcomes. [2018]