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Intravesical injection of highly purified botulinum toxin [Incobotulinumtoxin A (Xeomin)] for neurogenic bladder

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Sources of Funding: none

Introduction

Currently onabotulinumtoxin A (Botox®) is the only FDA-approved form of botulinum toxin for use in the bladder. However there are now alternative toxins on the market approved for muscle spasticity and cosmetics. Incobotulinumtoxin A (Xeomin®) is a highly purified toxin with no complexing proteins, decreased immunogenicity, improved storage and lower cost. The safety and efficacy of incobotulinumtoxin A use in the bladder has not previously been studied.

Methods

Patients who received intravesical incobotulinumtoxin A injections for neurogenic or idiopathic detrusor overactivity between 2013 and 2016 were identified. Those who previously received onabotulinumtoxin A had minimum washout interval of 3 months. Baseline characteristics were collected. Outcomes analyzed included UDI-6 scores, IIQ-7 scores, daily incontinence episodes, catheterized volume, pad use, and complications. Analysis with summary statistics and paired t-tests were done with significance p<0.05.

Results

14 male patients underwent incobotulinumtoxin A injection. Mean age was 59.8±16.9 years. All patients had neurogenic (n=12, 86%) or idiopathic (n=2, 14%) detrusor overactivity on urodynamics. At baseline, 79% were on oral anticholinergic therapy, 50% were performing CIC, 21% had indwelling catheters and 29% had received previous onabotulinumtoxin A. Initial injection doses were 300 units for 29%, 200 units for 64% and 100 units for 7%. 5 patients (36%) received multiple treatments (2.8±0.4 times) with mean 9.0±4.1 months between sessions. After treatment there were trends toward improvement in mean daily pad use (5.0±6.5 to 2.6±6.3, p=0.33), incontinence episodes (2.7±1.9 to 1.6±2.3, p=0.74), episodes of daytime frequency (7.8±2.7 to 6.6±7.0, p=0.60), CIC volumes (341.7±67.1 to 45070.7 mL, p=0.05) and UDI-6 scores (43.0±30.2 to 18.0±28.1, p=0.19). IIQ-7 scores significantly decreased after treatment (46.4±34.6 to 10.1±18.2, p=0.03). 2 patients (14%) experienced culture-proven urinary tract infections within 30 days of treatment and 1 patient (7%) developed new urinary retention.

Conclusions

This is the first study to demonstrate safety and efficacy of intravesical incobotulinumtoxin A in patients with neurogenic or idiopathic detrusor overactivity. Incobotulinumtoxin A may be an attractive alternative to onabotulinumtoxin A, especially given its lower cost. Small sample size limits this data, however early results suggest improvements in quality of life and bladder dynamics. A larger, prospective study will be required to validate these findings.

Funding

none

Authors
Denise Asafu-Adjei
Alex Small
Doreen Chung
Glen McWilliams
Cory Harris
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