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NCT06793683

Early BOTOX After Spinal Cord Injury

Enrolling by Invitation
EARLY_PHASE1Ages 18–65InterventionalPrevention
University of Washington
~10 participants
Updated 2025-01-27 on ClinicalTrials.gov
What's tested:Bladder chemodenervation (Botox)Bladder Sham (Saline) Injection Procedure

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of Enrollment goals
Measured over Each participant will be evaluated for a period of up to 12 months after the time of enrollment.
+1 more outcome measured

Conditions

Spinal Cord Injuries

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Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Claire C Yang, MD · PRINCIPAL_INVESTIGATOR · University of Washington

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Feasibility of Enrollment goalsEach participant will be evaluated for a period of up to 12 months after the time of enrollment.

    Outcomes of this pilot trial will provide human data on the feasibility of recruiting 10 participants into a randomized study of early chemodenervation. The enrollment goal is 10 participants who will complete the 12-month study protocol. If ≥ 8 participants complete the protocol, it will be considered feasible. If ≤ 5 participants complete the protocol, it will be considered unfeasible. If 6-7 participants complete the study, it will be considered indeterminate.

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0For each participant any AE's will be documented, at time of AE, beginning at study enrollment and throughout each participants 12 month enrollment period.

    Patients will be monitored for adverse events as a result of the procedures. * Evidence of Urinary Tract Infections * Hematuria * Anesthesia Complications Any adverse events (AE) will be graded 1 through 5, with unique clinical descriptions of severity for each AE, based upon the AE guidelines as published in the CAE v4.0