Procedure

Botox for Spinal Cord Injury

Seattle, WA

Phase < 1

Waitlist Available

Led By Claire C Yang, MD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female 18-65 years of age at time of SCI

Be older than 18 years old

Must not have

Acute (as part of concurrent hospitalization) or history of bladder surgery (urethral or prostate surgery acceptable) or injury

Inability to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up each participant will be evaluated for a period of up to 12 months after the time of enrollment.

Summary

This trial aims to study how starting early treatment with bladder chemodenervation can help preserve bladder function in individuals with a new spinal cord injury (SCI). The researchers want to track the changes that happen in

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Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed, Botox injections can generally cause pain at the injection site, urinary tract infections, difficulty urinating, and potentially systemic effects like muscle weakness or trouble breathing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old and have a spinal cord injury.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had bladder, urethral, or prostate surgery or an injury.

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I am unable to understand or sign the consent form.

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I don't have any health issues that would make bladder tests or treatments unsafe.

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My heart condition is unstable.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ each participant will be evaluated for a period of up to 12 months after the time of enrollment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~each participant will be evaluated for a period of up to 12 months after the time of enrollment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and each participant will be evaluated for a period of up to 12 months after the time of enrollment. for reporting.