Int Urogynecol J (2017) 28:1437 The International Urogynecological Association 2017 DOI 10.1007/s00192-017-3348-x Presented by Tamara Grisales Efficacy and safety of OnabotulinumtoxinA therapy are (I-QOL) total summary score. Adverse effects (AE) in- sustained over 4 Years of treatment in patients with neu- cluded urinary retention and initiation of CIC and devel- rogenic detrusor Overactivity: Final results of a long term opment of toxin neutralizing antibodies. extension study Of the 396 patients who entered the extension study, 240 Michael Kennelly, Roger Dmochowski, Heinrich Schulte- (60.6%) were followed at least 4 years. Only 2% (8/396) Baukloh, Karen Ethans, Giulio del Popolo, Courtney Moore, discontinued due to lack of efficacy, 3% (12/396) due to Brenda Jenkins, Steven guard, Yan Zheng, and Gilles AEs, and 5.8% (23/396) were lost to follow up. Karsenty. Neurourology and Urodynamics DOI 10.1002/nau The mean participant age was 46.4 years. At baseline, study patients reported mean of 4.5 UI episodes/day, and This was a 3-year extension study from a prospective, mul- 150.7 mL/void. At week 6 after each treatment, 200 units ticenter trial evaluating the efficacy of onabotulinumtoxin A reduced the number of mean daily UI episodes from baseline for the treatment of urinary incontinence (UI) from neurogenic by 3.2–4.1 UI episodes/day and increased voided volumes by detrusor overactivity (NDO). Patients with NDO due to mul- 133.2–166.1 mL. Secondary outcomes were as follows: The tiple sclerosis (MS) or spinal cord injury (SCI) who had failed proportion of patients achieving ≥50% reduction in UI epi- at least one anticholinergic, and completed one of two 52- sodes was 83.2–91.1%, and the proportion achieving 100% week phase III trials, were eligible to participate. reduction in UI episodes was 43–56% over 6 treatments. I- Patients received additional treatments of onubotulinumtoxin QOL scores nearly doubled from baseline of 34.4 after each A by patient request if they reported ≥1 UI episode/3 days AND treatment. Median duration of treatment effect was <6 months ≥12 weeks had elapsed since last treatment. Initially, the proto- in 22%, 6–12 months in 52% and >12 months in 26% of col allowed for patients to receive the same dose (200u or 300u) patients. Adverse effects included urinary retention measured that had been administered in the original study. However, after by denovo CIC rates. Of those who had not initiated CIC prior 2011, 200 unit dose was used for all extension study treatments. to treatment, 29.5% initiated CIC following their first treat- The primary outcome was a change in UI episodes per ment in the extension study. Denovo CIC rates were much day from study baseline at week 6 after each treatment. lower after subsequent treatments (3.4–6.0%). Development Baseline was defined as the value prior to the first treat- of toxin-neutralizing antibody occurred 2.3% (8/381) of pa- ment in the phase III studies. Secondary outcomes includ- tients enrolled in the extension study. Antibody formation was ed: the proportion of patients with >50% and 100% re- more common in those receiving higher doses and those re- ductions from baseline in UI episodes/day; changes from ceiving treatment more frequently (median time between baseline in volume/void, and Incontinence-Quality of Life treatments 4.9 vs 9.1 months). * Tamara Grisales TGrisales@mednet.ucla.edu UCLA Medical Center, Los Angeles, CA, USA
International Urogynecology Journal – Springer Journals
Published: May 9, 2017
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