At a glance
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Botulin-A Toxin/Dimethyl Sulfoxide Bladder Instillations for Treatment of Voiding Dysfunction Secondary to Detrusor Hyperreflexia and Detrusor Instability in Women
In Brief
A Phase 2 clinical trial evaluating Botulinum-A toxin and Dimethyl sulfoxide (DMSO) for Overactive Bladder and 2 related conditions. Completed, enrolled 25 participants across 1 site.
Detailed Summary
The primary objective of this pilot study is to evaluate the safety and efficacy of direct instillations of Botulinum-A toxin/DMSO into the bladder via a catheter system as a means of treating women with symptoms of overactive bladder and secondary urinary incontinence. In doing so, we will focus on estimating the percentage of women who experience an improvement in their urinary incontinence symptoms at one month and three months following this novel instillation technique.
Study Details
Timeline
Interventions
A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.
Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO.