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Observational Study
. 2021 Jan;32(1):65-74.
doi: 10.1007/s00192-020-04423-0. Epub 2020 Jul 27.

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

Rizwan Hamid  1 , Maria-Fernanda Lorenzo-Gomez  2 , Heinrich Schulte-Baukloh  3 , Amin Boroujerdi  4 , Anand Patel  5 , Elisabeth Farrelly  6
Affiliations
Observational Study

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

Rizwan Hamid et al. Int Urogynecol J. 2021 Jan.

Abstract

Introduction and hypothesis: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: OnabotulinumtoxinA; Overactive bladder; Quality of life; Urinary incontinence.

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Conflict of interest statement

Rizwan Hamid has served as a consultant for Allergan Plc.

Maria-Fernanda Lorenzo-Gomez has no financial conflicts of interest to disclose.

Heinrich Schulte-Baukloh has received travel expenses/honoraria from Allergan Plc.

Amin Boroujerdi and Anand Patel are employees of Allergan Plc.

Elisabeth Farrelly has served as a consultant for Allergan Plc.

Figures

Fig. 1
Fig. 1
a Change from baseline in UI episodes over time. b Proportion of patients with a positive (improved/greatly improved) response and no change/worsened response on the TBS at week 12. *Statistically significant (p < 0.001 vs. baseline). TBS, treatment benefit scale; UI, urinary incontinence
Fig. 2
Fig. 2
Reduction in incontinence product use from baseline over time. aWeek 52: only patients without reinjection of onabotulinumtoxinA. *Statistically significant (p < 0.05) vs. baseline
Fig. 3
Fig. 3
OAB medication use: Baseline: at enrollment; week 1: during the last week; week 12, 20, 28, 36, 52: during the last 4 weeks. Data at week 52 were only in patients without reinjection of onabotulinumtoxinA. Patients could receive more than one medication
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