Early BOTOX After Spinal Cord Injury

University of Washington

Status and phase: Invitation-only; Early Phase 1

Conditions: Spinal Cord Injuries

Treatments: Drug: Bladder chemodenervation (Botox); Procedure: Bladder Sham (Saline) Injection Procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT06793683

STUDY00018758

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Inability to return to research site (Harborview Medical Center) for follow-up studies after initial hospitalization.
• Acute (as part of concurrent hospitalization) or history of bladder surgery (urethral or prostate surgery acceptable) or injury.
• 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.
• 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.
• 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)
• Known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation
• Cardiovascular instability

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

10 participants in 2 patient groups

Bladder Chemodenervation (Botox) Injection Procedure

Active Comparator group

Description:

BoNT-A (Botox) 200 U, will be injected into the detrusor (bladder wall muscle).

Treatment:

Drug: Bladder chemodenervation (Botox)

Bladder Sham (saline) Injection Procedure

Sham Comparator group

Description:

Saline will be injected into the detrusor (bladder wall muscle).

Treatment:

Procedure: Bladder Sham (Saline) Injection Procedure