Botox for Spinal Cord Injury

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Washington

Must not be taking: Botulinum toxin

Disqualifiers: Bladder surgery, Pregnancy, Cardiovascular instability, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 months

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators would like to improve our understanding of how early intervention with the use of bladder chemodenervation can preserve bladder function in those with a new SCI. Although detrimental cystometric and tissue changes are known to occur, often within 3 months after SCI, the investigators seek to document the time course of these changes and the range of severity of those changes in both those participants that receive prophylactic treatment and those who do not.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Botox for treating bladder issues in spinal cord injury patients?

Research shows that Botox injections can help reduce urinary incontinence in patients with spinal cord injuries by relaxing the bladder muscle. In a study, 25.1% of patients experienced a marked reduction in incontinence, and 69.1% were satisfied with their treatment, even though some switched to other methods. Additionally, in animal studies, Botox helped maintain healthier bladder tissue after spinal cord injury. ^{1 2 3 4 5}

Is Botox safe for treating bladder issues in spinal cord injury patients?

Botox injections into the bladder have been shown to be generally safe for treating bladder issues in spinal cord injury patients. Common side effects include urinary tract infections and urinary retention, with rare reports of the toxin spreading to other areas. The treatment is FDA-approved and has a low incidence of complications. ^{6 7 8 9 10}

How is the drug Botox used for spinal cord injury different from other treatments?

Botox (botulinum toxin A) is unique for spinal cord injury as it is injected directly into the bladder muscle to reduce abnormal reflexes and prevent bladder wall thickening and scarring, which are common after injury. This approach helps maintain bladder tissue integrity, unlike other treatments that may not address these specific tissue changes. ^{3 7 11 12 13}

Research Team

Claire C Yang, MD

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for individuals with a new spinal cord injury (SCI) who may experience delayed wound healing. The study aims to see if early treatment can help preserve bladder function. Specific eligibility details are not provided, but typically participants must meet certain health conditions and cannot have factors that would exclude them from safely participating.

Inclusion Criteria

Ability for subject to comply with the requirements of the study

Written informed consent obtained from subject

English speaking

Exclusion Criteria

Known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation

Inability to return to research site (Harborview Medical Center) for follow-up studies after initial hospitalization

Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either BoNT-A (Botox) or saline injections into the detrusor muscle

12 months

Regular visits throughout the 12-month period

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and bladder function

12 months

Treatment Details

Interventions

• Bladder chemodenervation (Botox)

Trial Overview The study is testing the effectiveness of an early intervention called bladder chemodenervation using Botox compared to a sham procedure with saline solution. It seeks to understand how this treatment might prevent negative changes in bladder function following SCI.

Participant Groups

Group I: Bladder Chemodenervation (Botox) Injection Procedure Active Control 1 Intervention

BoNT-A (Botox) 200 U, will be injected into the detrusor (bladder wall muscle).

Group II: Bladder Sham (saline) Injection Procedure Placebo Group 1 Intervention

Saline will be injected into the detrusor (bladder wall muscle).

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Findings from Research

Botulinum neurotoxin (BoNT) injections into the bladder wall are an effective alternative for treating neurogenic detrusor overactivity (NDO) and urinary incontinence in patients who cannot tolerate anticholinergic medications, with FDA approval received in 2011.

The treatment has been shown to significantly decrease urinary incontinence and improve quality of life, while also increasing bladder capacity and reducing detrusor pressures, although common side effects include urinary tract infections and urinary retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of botulinum toxin in individuals with neurogenic detrusor overactivity: state of the art review. Linsenmeyer, TA.[2022]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Botulinum toxin A in the treatment of spinal cord injury patients with refractory neurogenic detrusor overactivity. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Satisfaction with Detrusor OnabotulinumtoxinA Injections and Conversion to Other Bladder Management in Patients with Chronic Spinal Cord Injury. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Early Detrusor Application of Botulinum Toxin A Results in Reduced Bladder Hypertrophy and Fibrosis after Spinal Cord Injury in a Rodent Model. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Botulinum toxin A for treatment of neurogenic detrusor overactivity and incontinence in patients with spinal cord lesions. [2010]

5. China pubmed.ncbi.nlm.nih.gov

[Efficacy of Botulinum-A toxin injection into bladder to treat neurogenic incontinence in patients with spinal cord injury: comparison of two doses]. [2018]

6. India pubmed.ncbi.nlm.nih.gov

The effect of spinal cord-injury level on the outcome of neurogenic bladder treatment using OnabotulinumtoxinA. [2020]

7. Australia pubmed.ncbi.nlm.nih.gov

Botulinum toxin A injection for the treatment of neurogenic detrusor overactivity secondary to spinal cord injury: multi-institutional experience in Japan. [2022]

8. India pubmed.ncbi.nlm.nih.gov

Will repeated botulinum toxin A improve detrusor overactivity and bladder compliance in patients with chronic spinal cord injury? [2021]

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

Use of botulinum toxin in individuals with neurogenic detrusor overactivity: state of the art review. [2022]

10. Sweden pubmed.ncbi.nlm.nih.gov

Effects of botulinum toxin A injections in spinal cord injury patients with detrusor overactivity and detrusor sphincter dyssynergia. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Botulinum toxin-type A in the treatment of drug-resistant neurogenic detrusor overactivity secondary to traumatic spinal cord injury. [2022]

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

Central inhibitory effect of intravesically applied botulinum toxin A in chronic spinal cord injury. [2011]

13. England pubmed.ncbi.nlm.nih.gov

Botulinum A toxin as a treatment of detrusor-sphincter dyssynergia in patients with spinal cord injury: MRI controlled transperineal injections. [2019]