Early BOTOX After Spinal Cord Injury

Ki vehet részt

• Male or female 18-65 years of age at time of SCI
• English speaking
• Recent SCI (within 20 weeks of injury)
• Documentation of a spinal cord injury at T6 or higher, American Spinal Injury Association Impairment Scale (AIS) level A or B as designated on initial (72 hour) AIS exam
• Ability for subject to comply with the requirements of the study
• Written informed consent obtained from subject

Ki nem vehet részt

• Acute (as part of concurrent hospitalization) or history of bladder surgery (urethral or prostate surgery acceptable) or injury
• Active medical problems precluding the safe conduct of urodynamics, bladder chemodenervation, bladder biopsy (e.g., evidence of active bladder infection, ruled out by urine culture prior to procedures)
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
• 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
• Inability to provide informed consent
• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
• Incarcerated in a detention facility or in police custody
• Cardiovascular instability