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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how early Botox treatment can help preserve bladder function in individuals with a recent spinal cord injury (SCI). Researchers aim to determine if Botox injections in the bladder muscle can prevent harmful changes within the first three months post-injury. Participants will receive either a Botox injection or a harmless saline injection for comparison. Ideal candidates have experienced a spinal cord injury at the T6 level or higher within the last 20 weeks and can communicate in English. As an Early Phase 1 trial, this research seeks to understand how Botox works in people, offering participants the opportunity to be among the first to receive this treatment.

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.

Is there any evidence suggesting that bladder chemodenervation (Botox) is likely to be safe for humans?

Research has shown that Botox injections have been studied for individuals with spinal cord injuries, particularly for bladder problems. These studies found that Botox can help manage bladder overactivity, a common issue in those with spinal cord injuries. The results indicate that Botox is generally well-tolerated.

In a study on Botox for bladder overactivity, most participants did not experience serious side effects. Some minor side effects included urinary tract infections and a small amount of blood in the urine, but these were uncommon.

Botox is already approved by the FDA for other conditions, such as muscle spasms and chronic migraines, indicating its safety for those uses. This can be reassuring.

Overall, research suggests that Botox is safe for many individuals with bladder issues due to spinal cord injury, with only minor side effects reported in most cases. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for spinal cord injury-related bladder issues, which often involve medications or surgeries to manage symptoms, Botox offers a unique approach by directly affecting the bladder muscle. Botox (Botulinum toxin A) is injected into the detrusor muscle of the bladder, temporarily paralyzing it and reducing overactivity. This localized action can lead to significant improvements in bladder control and reduce the need for more invasive procedures. Researchers are excited about Botox because it targets the root cause of bladder dysfunction in spinal cord injuries, offering a potentially more effective and less invasive solution.

What evidence suggests that bladder chemodenervation (Botox) might be an effective treatment for spinal cord injury?

Research has shown that Botox, a type of botulinum toxin, can improve bladder function in people with spinal cord injuries. In this trial, participants will receive either a Botox injection or a saline sham injection into the bladder muscle. Studies have found that injecting Botox into the bladder muscle reduces its overactivity, which often occurs after spinal cord injuries and leads to urinary incontinence (loss of bladder control). Specifically, individuals with bladder muscle contraction issues due to nerve problems have experienced fewer daily incontinence episodes after Botox treatment. Botox relaxes the bladder muscles, improving bladder control. Overall, Botox serves as an effective option for managing bladder issues related to spinal cord injuries. ^{3 4 5 6 7}

Who Is on the Research Team?

Claire C Yang, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00711087

Botox-A Injection to Improve Bladder Function in Early ...

The purpose of this study is to see what the effect of Botox has on bladder function for those who have recently suffered spinal cord injury.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0003999313003171

Meta-Analysis of Botulinum Toxin A Detrusor Injections in ...

To examine the effectiveness of botulinum toxin type A (BTX-A) on neurogenic detrusor overactivity (NDO) in individuals with spinal cord injury (SCI). Data ...

3.

nature.com

nature.com/articles/3102070

Botulinum toxin for treatment of urinary incontinence due to ...

Two BTX-A trials enrolled primarily patients with NDO secondary to spinal cord injury (SCI) (93%). BTX-A decreased daily UI episodes compared to ...

4.

mdpi.com

mdpi.com/2072-6651/15/4/288

Treating Neurogenic Lower Urinary Tract Dysfunction in ...

BoNT-A injections into the detrusor muscle, urethral sphincter, or both are used as an effective treatment for SCI patients with LUTS to ...

5.

einj.org

einj.org/journal/view.php?doi=10.5213/inj.1836118.059

A Systematic Review and Meta-analysis

Botulinum toxin A inhibits ATP release from bladder urothelium after chronic spinal cord injury. Neurochem Int 2004;45:987-93. crossref pmid.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5227327/

Botulinum toxin in spinal cord injury patients with ...

In patients with neurological disorders, bladder dysfunction associated with detrusor overactivity (DO) impairs quality of life (QoL) and often poses a threat ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00311376

Safety and Efficacy Study of Botulinum Toxin Type A for the ...

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple ...