NCT06793683

Early BOTOX After Spinal Cord Injury

Early Detrusor Chemodenervation to Preserve Bladder Compliance and Longevity After Spinal Cord Injury

• Status: Enrolling By Invitation
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DRUG	Bladder chemodenervation (Botox)	BoNT-A (Botox) 200 U will be injected into the detrusor (bladder wall muscle).
PROCEDURE	Bladder Sham (Saline) Injection Procedure	20mL placebo (saline only), will be injected into the detrusor (bladder wall muscle).

Timeline

• Start date: 2024-07-27
• Primary completion: 2028-04-30
• Completion: 2028-09-30
• First posted: 2025-01-27
• Last updated: 2025-01-27

Locations

1 site across 1 country: United States