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Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 5, 2020 (before its estimated January 1, 2021 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Primary completion date: Aug 1, 2020 to Jan 1, 2021v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Currently, in clinical practice there has been no standardization in the number of injections a single dose of intradetrusor onabotulinumtoxin A is administered in. Given the increasing use of this treatment modality, the aim of this study is to compare outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to 20 injections for the treatment of overactive bladder or urgency urinary incontinence refractory to medical treatment.
Trial Details
NCT Number NCT04305743
Lead Sponsor University of South Florida
Collaborators: Medstar Health Research Institute
Conditions
(from sponsor)
Urinary Bladder, Overactive, Incontinence, Urge, Incontinence, Urinary, Urinary Urge Incontinence, Urinary Frequency More Than Once at Night, Nocturia
Related terms Nocturia, Urinary Bladder, Overactive, Urinary Incontinence, Urinary Incontinence, Urge
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov