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Early BOTOX After Spinal Cord Injury

NCT06793683 · Status: ENROLLING_BY_INVITATION · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-01-27

No results posted yet for this study

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

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).

Sponsors & Collaborators

Principal Investigators

  • Claire C Yang, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-27
Primary Completion
2028-04-30
Completion
2028-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06793683 on ClinicalTrials.gov