Spinal Cord Injuries
Conditions
Keywords
SCI, Neurogenic Bladder, Chemodenervation with BoNT-A, Botox, Autonomic Dysreflexia
Brief 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.
Interventions
DRUGBladder chemodenervation (Botox)
BoNT-A (Botox) 200 U will be injected into the detrusor (bladder wall muscle).
PROCEDUREBladder Sham (Saline) Injection Procedure
20mL placebo (saline only), will be injected into the detrusor (bladder wall muscle).
Sponsors
University of Washington
Congressionally Directed Medical Research Programs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants will be blinded during the study.
Intervention model description
The investigators hope to recruit 10 participants randomly assigned to 7 cases (those that will receive Botox bladder injections) and 3 controls (those that will receive placebo bladder injections).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Enrollment goals | Each 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 v4.0 | 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. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variance of measurements for functional data | Variances of all measurements and data, for each subject, will be analyzed at the conclusion of their study participation, 12 months post enrollment. | 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. |
| Variance of measurements for histological data | Variances of all measurements and data will be analyzed at the conclusion of the study (expected in 2028). | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORClaire C Yang, MD
University of Washington
Outcome results
None listed