SCOTTSDALE, AZ USA (UroToday.com) - This was a 4-year, multicenter study of long-term efficacy/safety of onabotulinumtoxinA (BTA) in patients with urinary incontinence (UI) due to neurogenic detrusor overactivity (NDO). These patients had been refractory to anticholinergic medication, had either multiple sclerosis (MS) or spinal cord injury (SCI), and had completed a phase 3 study and opted to enroll in a 3-year extension study. They received multiple intradetrusor BTA treatments (200U or 300U). The primary efficacy measure was change from baseline of UI episodes/day. Voided urine volume/void, duration of effect of an individual injection, adverse events (AEs), and rate of new incomplete bladder emptying requiring intermittent self-catheterization (ISC) was assessed.
Three hundred ninety-six patients entered the extension study and over 60.6% (240) continued through 4 years of TX, a better completion rate than seen in anticholinergic medication trials, which report 49% after 2 years of follow-up. In this population, it was not surprising that discontinuation rates due to AEs/lack of efficacy were low (3.0%/2.0%). As to outcomes, baseline mean UI episodes/day were 4.5 and by week 6, decreases of -3.2 to -4.1 were seen. Volume voided nearly doubled (baseline 150.9 mL; over 6 injections increase ranged from 133.2mL to 166.1mL) and this improvement was seen with BTA of 200Units/treatment. Increasing to 300U BTA did not increase efficacy. Most common AEs were UTIs and urinary retention. The authors reported on de novo ISC with injections of BTA 200U.
What is interesting in this data is that the percentage of patients who needed to perform ISC rates decreased over the 6 weeks (TX 1=29.5%, TX 2=3.4%, and TX 3 =6.0%; TXs 4-6= 8%), but was higher in patients who received 300U injections for TX 4 to 6. The authors concluded that over a 4-year period, BTA continued to reduce UI and improved voided volume, and no new safety concerns occurred in this population of patients with NDO.
Funding: Allergan, Inc.
Presented by C. Moore, R. Dmochowski, K. Ethans, H. Schulte-Baukloh, B. Jenkins, S. Guard, Y.Zheng, G. Karsenty, and M.Kennelly at the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) Winter Meeting - February 24 - 28, 2015 - JW Marriott Camelback Inn Resort & Spa - Scottsdale, AZ USA
Reported by Diane K. Newman, DNP, FAAN, BCB-PMD, medical writer for UroToday.com