(HealthDay News) — OnabotulinumtoxinA treatment is safe and effective for long-term treatment of overactive bladder syndrome, according to a study published in the September issue of The Journal of Urology.
Victor W. Nitti, MD, from New York University in New York City, and colleagues examined the final results of a 3.5-year study of the efficacy/safety of onabotulinumtoxinA for overactive bladder syndrome. Patients who had completed one of two 24-week phase 3 trials were eligible for a 3-year extension to continue treatment with onabotulinumtoxinA as needed for symptom control.
The researchers found that following continued onabotulinumtoxinA treatment, there were consistent mean reductions in urinary incontinence, ranging from −3.1 to −3.8 in the overall population, and from −2.9 to −4.5 in the discrete subgroups that received 1 to 6 treatments. There were durable improvements in overactive bladder symptoms and quality of life. The proportion of patients who rated their condition as improved/greatly improved was high. The median effect duration was 7.6 months. Urinary tract infection was the most common adverse effect. After the first treatment, the rate of de novo catheterization was 4.0%, and it varied from 0.6 to 1.7% after subsequent treatments.
“Long-term onabotulinumtoxinA treatment consistently decreased overactive bladder symptoms and improved quality of life with no new safety signals,” the authors write.
The study was funded by Allergan, the manufacturer of onabotulinumtoxinA.
1. Nitti VW, Ginsberg D, Sievert KD, et al. Durable Efficacy and Safe Long-Term OnabotulinumtoxinA Treatment in Patients with Overactive Bladder Syndrome: Final Results of a 3.5-Year Study. J Urol. doi: 10.1016/j.juro.2016.03.146.