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

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

doi:10.1007/s00192-020-04423-0

Abstract

Introduction and hypothesisIn 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.MethodsThis 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.ResultsPhysicians 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.ConclusionsIn 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.

Highlights

Introduction and hypothesisIn randomized clinical trials onabotulinumtoxinA was demonstrated to be an effective and welltolerated treatment for overactive bladder (OAB) with urinary incontinence (UI)
Retreatment with onabotulinumtoxinA was based on patient request and physician judgment at the follow-up visits when this was in line with the local summaries of product characteristics (SMPC) and the treating physician’s normal clinical practice
This real-world study is the largest prospective, multinational, observational study performed to date and was designed to evaluate the efficacy and safety of treatment with onabotulinumtoxinA in patients with OAB as well as the treatment methodologies used by the physicians in their day-today clinical practices

Summary

Introduction

In randomized clinical trials onabotulinumtoxinA was demonstrated to be an effective and welltolerated treatment for overactive bladder (OAB) with urinary incontinence (UI). Data reporting onabotulinumtoxinA use in everyday clinical practice are limited. Overactive bladder (OAB) is a syndrome characterized by the International Continence Society as “urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection or other obvious pathology” [1]. An estimated 546 million people worldwide are affected by symptoms consistent with OAB; approximately 423 million have urinary incontinence (UI) [2]. UI as a result of OAB can significantly affect quality of life (QoL) and, as a result of social embarrassment, many patients. Int Urogynecol J (2021) 32:65–74 can suffer from low self-esteem resulting in avoidance and limited social behavior. There is a substantial direct cost to the patient with UI primarily from the use of absorbent products [6] as well as indirect sequelae costs [7]

Objectives

Results

Discussion

Conclusion