ClinicSpeak: long-term follow-up study for bladder botox

A me-too bladder botox injection to get excited about. #ClinicSpeak #MSBlog #MSResearch

"Last week in the BMJ there was an article on why the current Pharma model is not innovating fast enough. One of the reasons is that Pharma go for low hanging fruit and would rather create 'me toos' and then compete for market share using large marketing budgets. The study below is of a me-too bladder botox formulation that surprise-surprise works in people with neurogenic bladder; it reduces episodes of incontinence, increases bladder volume (this how it works) and improves quality of life. This study provides new data for the sales and marketing people to peddle their wares."

"If you have neurogenic bladder with frequency, urgency and urgency incontinence and you need to self catheterise you may be a good candidate for bladder botox. Too many pwMS suffer in silence when they should be referred earlier for this treatment. Please discuss this issue with your MS team."

"I can't help but dream of a world where we treat MS effectively, early, before pwMS have any significant bladder dysfunction and never have a need for bladder botox. Now wouldn't  that be wonderful?"

Epub: Kennelly et al. Efficacy and safety of onabotulinumtoxinA therapy are sustained over 4 years of treatment in patients with neurogenic detrusor overactivity: Final results of a long-term extension study. Neurourol Urodyn. 2015 Nov 24. doi: 10.1002/nau.22934.

AIMS: To present final efficacy/safety results from a prospective, long-term extension trial of onabotulinumtoxinA for urinary incontinence (UI) due to neurogenic detrusor overactivity (NDO); patients received treatment for up to 4 years.

METHODS: Patients who completed a 52-week, phase III trial of onabotulinumtoxinA for NDO were eligible to enter a 3-year, multicenter, open-label extension study of intradetrusor onabotulinumtoxinA (200U or 300U). Patients were treated "as needed" based on their request and fulfillment of prespecified qualification criteria (≥12 weeks since previous treatment and a UI episode threshold). Assessments included change from study baseline in UI episodes/day (primary efficacy measure), volume/void, and Incontinence Quality of Life (I-QOL) total score (week 6); duration of effect; adverse events (AEs); and initiation of de novo clean intermittent catheterization (CIC). Data are presented for up to six treatments.

RESULTS: OnabotulinumtoxinA 200U consistently reduced UI episodes/day; reductions from baseline ranged from -3.2 to -4.1 across six treatments. Volume/void consistently increased, nearly doubling after treatment. I-QOL improvements were consistently greater than twice the minimally important difference (+11 points). Overall median duration of effect was 9.0 months (200U). Results were similar for onabotulinumtoxinA 300U. Most common AEs were urinary tract infections and urinary retention. De novo CIC rates were 29.5, 3.4, and 6.0% (200U), and 43.0, 15.0, and 4.8% (300U) for treatments 1-3, respectively; de novo CIC rates were 0% for treatments 4-6.

CONCLUSIONS: OnabotulinumtoxinA treatments consistently improve UI, volume/void, and QOL in patients with UI due to NDO in this 4-year study, with no new safety signals.

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