Botox effective long-term treatment for overactive bladder in women

Allergan has announced results from an extension study of two Phase 3 trials that show that long-term onabotulinumtoxinA (Botox) treatment consistently decreased urinary incontinence in female patients with overactive bladder who have had an inadequate response to or are intolerant of an anticholinergic medication.

Overactive bladder is a condition where the bladder contracts uncontrollably, creating leakage, the strong sudden need to “go right away,” and going too often. It occurs when nerves are affected. These nerves send signals to the bladder at the wrong time, causing the muscle to squeeze without warning. This process causes the bladder to spasm uncontrollably.

Findings were based on a 3.5-year extension study assessing the long-term safety and efficacy of onabotulinumtoxinA treatment in 749 female patients with overactive bladder. Of the 749 female patients enrolled, more than half (53%) completed the study.

Findings may help inform specialists treating patients with overactive bladder

Data were analysed for the overall population of patients and within discrete subgroups of patients who received exactly 1, 2, 3, 4, 5, or 6 treatments of the 100U dose throughout the study. Mean reductions from baseline in urinary incontinence episodes/day (week 12; co-primary endpoint) were consistent among discrete subgroups of female patients who received 1 to 6 treatments. A consistently high proportion of patients reported improvement or great improvement on the Treatment Benefit Scale (week 12; co-primary endpoint) in the discrete subgroups across all treatments. Incontinence Quality of Life scores were consistently >2.5 times the minimal important difference. The overall median duration of effect was 8. The most common adverse event was urinary tract infection, with no changes in safety profile over time.

“Results of this extensive 3.5-year study demonstrates consistent safety and efficacy of long-term onabotulinumtoxinA treatment in this population of female overactive bladder patients,” said Peter Sand, M.D., urogynaecologist and clinical professor, North Shore University Health System, University of Chicago. “These findings may help inform specialists treating patients with overactive bladder, that Botox is an effective and safe treatment option for patients not getting the relief from an anticholinergic.”