OnabotulinumtoxinA 100U has been shown to reduce urinary incontinence (UI) and significantly improve quality of life in patients with overactive bladder (OAB) in 2 large, randomized, placebo-controlled, phase 3 trials. Little information is available regarding the details of procedures used to administer onabotulinumtoxinA in everyday clinical practice. Here we present results from a phase 4 study focusing on methodologies used for onabotulinumtoxinA administration for the treatment of patients with OAB in real-world practice.

This 12 month prospective, observational, non-randomized multinational study (ClinicalTrials.gov: NCT02161159) was performed in 4 European countries. Efficacy outcomes included reduction from baseline in UI episodes/day and incontinence product (liner/pads/diapers) use. Injection procedure methodologies include onabotulinumtoxinA dose, number of injection sites, cystoscope (rigid or flexible), type of anesthesia, injection site, and injection depth. If requested patients could receive retreatment ≥12 weeks post-treatment. This study was performed in compliance with Good Clinical Practice regulations and was approved by the independent ethics committee at each site prior to study initiation as required by each country. All patients provided written informed consent prior to initiation of any study treatment.

Overall, 504 patients received onabotulinumtoxinA with 639 treatment sessions over 52 weeks. UI episodes/day decreased from a mean (standard deviation, SD) of 4.9 (4.2) at baseline to 1.9 (3.4) at week 12; p < .001. A baseline the median number of incontinence products used in the previous month was 60. This was significantly less at 12 weeks (15, p < .001) and was sustained to 52 weeks (7, p < .001). Real-world treatment patterns associated with these results were a mean (SD) total onabotulinumtoxinA dose/patient of 101 (76) U/treatment with a mean (SD) number of injections of 17.3 (5.2). Rigid cystoscopes were used during most treatments (85%); anesthesia was used for all but 2 (0.3%) treatments (intravesical instillation, 37.4%; local anesthetic gel, 32.1%, general anesthesia, 27.1%, and sedation, 18.3%). Injections were mostly distributed between the trigone and trigone-sparing (64.5%) sites, with depth of injections mostly submucosal (84.2%).

Patients saw beneficial effects of onabotulinumtoxinA while receiving the labeled dose with fewer than the indicated 20 injections as per the US package insert. Rigid cystoscopies were primarily used, providing insight into the use of anesthesia. Trigone and trigone sparing sites were injected during most procedures in the submucosal layer.

This real-world study is the first of its kind to provide large scale details of common procedural techniques used when administering onabotulinumtoxinA for OAB and could assist physicians in providing patients with effective onabotulinumtoxinA treatment.