Early BOTOX After Spinal Cord Injury

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT06793683
Phase
EARLY_PHASE1
Status
Enrolling By Invitation

Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Bladder chemodenervation (Botox) — DRUG
    BoNT-A (Botox) 200 U will be injected into the detrusor (bladder wall muscle).
  • Bladder Sham (Saline) Injection Procedure — PROCEDURE
    20mL placebo (saline only), will be injected into the detrusor (bladder wall muscle).

Study Details

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.

Key Dates

Start date
Jul 27, 2024
Status verified
Dec 2024
Primary completion
Apr 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Bladder Chemodenervation (Botox) Injection Procedure
    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).

Primary Outcome Measure

Feasibility of Enrollment goals [ Time Frame: Each participant will be evaluated for a period of up to 12 months after the time of enrollment. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Harborview Medical CenterSeattleWashington98104-

Find similar trials in Seattle, WA

By research site
Harborview Medical Center· Seattle, WA

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