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JU INSIGHT Intravesical Instillation of OnabotulinumtoxinA in the Treatment of Refractory Overactive Bladder in Participants with Urinary Incontinence

By: Christopher J. Chermansky, MD; Holly E. Richter, PhD, MD; Karny Jacoby, MD; Wilson Titanji, PhD; Brenda Jenkins, BS; Till Geib, PhD; Benjamin M. Brucker, MD | Posted on: 01 Oct 2022

Chermanksy CJ, Richter HE, Jacoby K, et al. Intravesical instillation of onabotulinumtoxina in the treatment of refractory overactive bladder in participants with urinary incontinence. J Urol. 2022;208(4)855-862.

Study Need and Importance

Intradetrusor injections of onabotulinumtoxinA are efficacious for the treatment of adults with urgency urinary incontinence from overactive bladder refractory to or intolerant of anticholinergics. Intravesical instillation an admixture of onabotulinumtoxinA and hydrogel via instillation was expected to allow for prolonged drug residence time in the bladder thereby allowing delivery into the bladder wall. This was hoped to result in a more accessible, simpler, and convenient mode of administration compared to intradetrusor injections, and it was hoped that this delivery would result in lower rates of urinary retention and urinary tract infection.

What We Found

Intravesical onabotulinumtoxinA and hydrogel admixture was well tolerated across treatment arms of different doses, with no indication of a safety dose response. Asymptomatic bacteriuria was the most frequently reported adverse event (6.7%–15.5%). There were no reports of urinary retention or elevated post-void residual volume. No active treatment arm separated from placebo for any of the efficacy end points. Change from baseline to week 12 for the primary end point of number of urinary incontinence episodes was −2.72 with placebo and ranged from −0.89 to −1.85 in the onabotulinumtoxinA + hydrogel treatment groups (see Figure).

Limitations

A limitation of this trial was the small number of male patients, which was to be expected in an overactive bladder study requiring treatment through a transurethral catheter.

Interpretation for Patient Care

Figure. Change in urinary incontinence (UI) episodes/day over time (primary end point). For all dose groups vs placebo at the primary time point of week 12, p >0.05, except 300 U onabotulinumtoxinA (OnabotA) + hydrogel versus placebo + hydrogel, for which p=0.0041. LS, least squares.

This multicenter trial showed that intravesical instillation of an onabotulinumtoxinA + hydrogel admixture for the treatment of urgency urinary incontinence from overactive bladder was well tolerated; however, it had little observed efficacy and it had a high placebo response. The observed lack of efficacy might be due to the very large size of onabotulinumtoxinA (approximately 900 kDa), too large to diffuse across the urothelium. Future injection-free studies for the delivery of onabotulinumtoxinA to the bladder should focus on a more effective delivery method.

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