Botox for Spinal Cord Injury
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.12345Why 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.34567
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either BoNT-A (Botox) or saline injections into the detrusor muscle
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and bladder function
What Are the Treatments Tested in This Trial?
Interventions
- Bladder chemodenervation (Botox)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor