New Orleans—In patients with overactive bladder syndrome, treatment with onabotulinumtoxinA (onabotA) 100U resulted in consistent reductions in daily urinary incontinence episodes. That was among the findings of a study conducted recently by Victor Nitti, MD, and colleagues. Results of the multicenter, extension study were reported during a session at the AUA 2015 Annual Meeting.
Patients were eligible to enter the 3-year extension study after completion of either of two 24-week, randomized, phase 3 trials. In the extension study, the patients could receive multiple intradetrusor onabotA treatments. The patients were treated as needed based on their request and fulfillment of prespecified qualification criteria. The coprimary end point was change in urinary incontinence episodes per day.
In order to evaluate consistency of response to repeated treatments, data were assessed for the discrete subpopulations of patients who needed exactly one (n=105), two (n=118), three (n=117), four (n=83), five (n=46), or six (n=33) treatments with onabotA during the study period. Mean change in urinary incontinence episodes per day at week 12 following treatment, proportion of patients with an overall median time to request retreatment (duration of effect) of 6 months of less, 6 to 12 moths, and more than 12 months, and adverse events (AEs) were assessed.
There were 53 patients who received onabotA 100U. Of those, 51.2% completed the study. The most common reasons for discontinuation were not related to treatment (personal reasons, study burden, site closure); discontinuations related to AEs or lack of efficacy were low (5.3% and 2.8%, respectively).
At baseline, mean urinary incontinence episodes per day were 4.5, 5, 5.8, 5.9, 5.2, and 5.7 in the subgroups of patients who needed one, two, three, four, five, and six treatments with onabotA 100U, respectively, during the study period. Irrespective of the number of treatments needed, at week 12 after each treatment, mean reductions in urinary incontinence episodes per day were consistent in all subgroups. The ranges for subgroups who received one, two, three, four, five, and six treatments were -3.1; -2.9 to -3.2; -4.1 to -4.5; -3.4 to -3.8; -3 to -3.6; and -3.1 to -4.1, respectively.
Patients who received fewer treatments had longer duration of effects compared with patients who received more treatments. The median time to request retreatment was 6 months or less for 34.2%, 6 to 12 months for 37.2%, and more than 12 months for 28.5% of patients; overall median duration of effect was 7.6 months.
The most common AE observed was urinary tract infections. There were no changes in safety profile observed over time.
“Long-term treatment with onabotA 100U resulted in consistent reductions in daily urinary incontinence episodes with a median duration of effect >6 months in [approximately two-thirds] of patients and >12 months in almost [one-third] of patients. No increase in [AEs] rates were observed with repeated treatment,” the researchers said.
Source: Nitti V, De Ridder D, Sussman D, et al. Durable reduction sin urinary incontinence with long-term onabotulinumtoxinA treatment in patients with overactive bladder syndrome: Final results of a 3.5-year study. Abstract of a presentation at the American Urological Association 2015 Annual Meeting, New Orleans, Louisiana, May 18, 2015.