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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
10
BoNT-A (Botox) 200 U will be injected into the detrusor (bladder wall muscle).
20mL placebo (saline only), will be injected into the detrusor (bladder wall muscle).
Harborview Medical Center
Seattle, Washington, United States
Feasibility of Enrollment goals
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.
Time frame: Each participant will be evaluated for a period of up to 12 months after the time of enrollment.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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
Time frame: For each participant any AE's will be documented, at time of AE, beginning at study enrollment and throughout each participants 12 month enrollment period.
Variance of measurements for functional data
Determination of variance of measurements for functional data, including: Cystometric values will be analyzed as a continuous variable and compared between early detrusor oBoNT-A injected cases and controls at the 6- and 12-month time points. Standard clinical care characterizes bladder compliance as poor for values \<10 mL/cm H2O, indeterminate for values between 10 mL/cm H2O and 20 mL/cm H2O, and good for values \>20 mL/cm H2O. To interpret our data, we will use these existing clinical guidelines in concert with statistical differences that arise.
Time frame: Variances of all measurements and data, for each subject, will be analyzed at the conclusion of their study participation, 12 months post enrollment.
Variance of measurements for histological data
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Determination of variance of measurements for histological data, including: Histological analyses of the bladder biopsy samples will include standard histological staining to evaluate hypertrophy and fibrosis, and how these parameters change with time (baseline, 6 months and 12 months post SCI).
Time frame: Variances of all measurements and data will be analyzed at the conclusion of the study (expected in 2028).