Interim Analysis of the Long-term Efficacy and Safety of Repeat OnabotulinumtoxinA in the Treatment of Idiopathic Overactive Bladder and Urinary Incontinence, Median 2.4 Years’ Follow up

Stefano Salvatore1, Christopher Chapple2, David Sussman3, Sidney Radomski4, Peter Sand5, Steven Guard6, Jihao Zhou7, Karl-Dietrich Sievert8, Victor Nitti9
1San Rafaelle Hospital, Milan, Italy.
2Royal Hallamshire Hospital, Sheffield, UK.
3NJ School of Osteopathic Medicine, Newark, NJ, USA.
4University of Toronto, Toronto, Canada.
5University of Chicago, Chicago, IL, USA.
6Allergan Ltd., Marlow, UK.
7Allergan, Inc., Bridgewater, NJ, USA.
8University of Tuebingen, Tuebingen, Germany.
9New York University, New York, NY, USA.

Topic: Urinary incontinence

Objective: To assess long-term efficacy/safety of repeated onabotulinumtoxinA treatments in idiopathic overactive bladder (OAB) patients with urinary incontinence (UI) who were inadequately managed by ≥1 anticholinergic (ACH).

Methods: Patients completing either of two phase 3 studies could enter this 3 year extension study (N=829) and receive multiple onabotulinumtoxinA (100U) treatments. Data were analysed for treatments 1-5. Efficacy, safety, and health-related quality of life (HRQOL) parameters, and positive response on the Treatment Benefit Scale (TBS), were assessed.

Results: As of this interim analysis, median follow-up was 2.4 years and discontinuation rates due to AEs/lack of efficacy were low (4.5%/4.9%). For treatments 1-5, onabotulinumtoxinA reduced UI at week 12 from baseline (-3.26, -3.70, -3.87, -3.20, and -3.22 episodes/day), median duration was 24.0, 31.6, 27.9, 24.3, and 23.9 weeks, and 74.0, 80.9, 80.4, 79.4, and 86.1% of patients reported a positive TBS response. Consistent improvements in other OAB symptoms and HRQOL were observed. Most common AE was urinary tract infection; CIC rates were between 0.8% and 4.5%.

Conclusions: Patients with OAB and UI inadequately managed by ≥1 ACH showed sustained improvements in OAB symptoms and HRQOL after repeated onabotulinumtoxinA treatment, with no new safety concerns.