Early BOTOX After Spinal Cord Injury

January 23, 2025 updated by: Claire Yang, MD, University of Washington

Early Detrusor Chemodenervation to Preserve Bladder Compliance and Longevity After Spinal Cord Injury

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bladder Chemodenervation (Botox) Injection Procedure
BoNT-A (Botox) 200 U, will be injected into the detrusor (bladder wall muscle).
Drug: Bladder chemodenervation (Botox)
BoNT-A (Botox) 200 U will be injected into the detrusor (bladder wall muscle).
Sham Comparator: Bladder Sham (saline) Injection Procedure
Saline will be injected into the detrusor (bladder wall muscle).
Procedure: Bladder Sham (Saline) Injection Procedure
20mL placebo (saline only), will be injected into the detrusor (bladder wall muscle).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Enrollment goals
Time Frame: 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.
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
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.

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
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variance of measurements for functional data
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.

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.
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
Time Frame: 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).
Variances of all measurements and data will be analyzed at the conclusion of the study (expected in 2028).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Investigators

  • Principal Investigator: Claire C Yang, MD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2024

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

September 30, 2028

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

January 23, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00018758

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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