OnabotulinumtoxinA is a well tolerated and effective treatment for refractory overactive bladder in real-world practice.

In randomized clinical trials onabotulinumtoxinA was demonstrated to be an effective and well-tolerated treatment for overactive bladder (OAB) with urinary incontinence (UI). However, data reporting onabotulinumtoxinA use in everyday clinical practice are limited. Here, we present the results from a large, first-of-its-kind real-world study in patients with OAB.

This was a prospective, observational, multinational study (GRACE; ClinicalTrials.gov , NCT02161159) performed in four European countries. Patients (N = 504) aged ≥ 18 years with OAB inadequately managed with ≥ 1 anticholinergic received onabotulinumtoxinA per their physician's normal clinical practice.

Physicians primarily used rigid cystoscopes for onabotulinumtoxinA injection; anesthesia/analgesia was utilized during most treatment procedures. Significant reductions in UI episodes/day from baseline to weeks 1 and 12 were observed as well as in micturition, urgency, and nocturia episodes/day. These improvements in urinary symptoms corresponded to higher scores on the treatment benefit scale at week 12. The use of other OAB medications dropped from baseline to weeks 1 and 12 and was sustained to week 52, which paralleled a reduction in the number of incontinence products used during that time frame. Adverse reactions were reported in 2.6% of patients throughout the study.

In this real-world study, significant improvements in urinary symptoms were seen following onabotulinumtoxinA treatment as early as week 1 and sustained to at least week 12. This was accompanied by a reduced reliance upon incontinence products and reduction in concomitant OAB medication use. OnabotulinumtoxinA was well tolerated with no new safety signals.

International urogynecology journal. 2020 Jul 27 [Epub ahead of print]

Rizwan Hamid, Maria-Fernanda Lorenzo-Gomez, Heinrich Schulte-Baukloh, Amin Boroujerdi, Anand Patel, Elisabeth Farrelly

University College London Hospitals, Euston Road, London, NW1 2BU, UK. ., University Hospital of Salamanca, Salamanca, Spain., Urologic practice, Department of Urology, Charité University Hospital, Berlin, Germany., Allergan plc, Irvine, CA, USA., Allergan plc, Marlow, UK., Södersjukhuset, Stockholm South General Hospital, Stockholm, Sweden.

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