OnabotulinumtoxinA for the Treatment of Patients with Overactive Bladder and Urinary Incontinence: Results of a Phase 3, Randomized, Placebo Controlled Trial

Νitti, Victor W.; Dmochowski, Roger R.; Herschorn, Sender; Sand, Peter K.; Thompson, Catherine; Nardo, Christopher; Yan, Xiaohong; Haag‐Molkenteller, Cornelia

doi:10.1016/j.juro.2012.12.022

Cited by 348 publications

(378 citation statements)

References 21 publications

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“…The efficacy results in this real-world study differed from those reported in published phase 3 clinical trials by Nitti et al 4 and Chapple et al 12 Both of these reported a significant decrease in the mean frequency of daily UI episodes, ranging from 53.1-57.5%. While the proportional changes in UI episodes for the de novo group were not significant in this study, an increased proportion reported being dry at the three-month followup, and among the cohort of patients incontinent at baseline, 50% became dry.…”

Section: Discussioncontrasting

confidence: 96%

“…Our safety results also differ from phase 3 clinical trials, 4,12 but are in keeping with other real-world studies. 13 Both phase 3 trials reported UTI as the most frequent adverse event, ranging from 15.5-20.4%, which is lower than the 26.6% rate observed in the de novo group of this study, and the 35% rate reported by Osborn et al These trials also reported rates of initiating self-catheterization of 6.1-6.9%, compared to 16.7% of the de novo group in this study.…”

Section: Discussionsupporting

confidence: 83%

“…2 These guidelines are based on high-quality, randomized controlled trials (RCTs) that have been published in the recent past. [1][2][3][4][5] Meta-analyses of these RCTs report significant improvements in OAB-related outcomes, including incontinence, urodynamics, and patient-reported outcomes (PROs), along with few adverse events. [6][7][8] One such review outlines that 60-65% of patients injected at a 100 U dose reported improvements in urgency incontinence, symptom scores, and quality of life.…”

Section: Introductionmentioning

confidence: 99%

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OnabotulinumtoxinA for the treatment of idiopathic overactive bladder is effective and safe for repeated use

Carlson

Civitarese

Baverstock

2017

CUAJ

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Introduction: The objective of this study was to compare efficacy and safety outcomes between patients receiving onabotulinumtoxinA (OnabotA) for the first time and those receiving a repeat injection. Methods: Data collected before and after OnabotA injection were extracted from a clinical registry. Patients were classified into either first or repeat injection subgroups. Efficacy was measured by the change in use of oral bladder medications, the number of voids per day or night, the frequency of urinary incontinence (UI) episodes, and patient-reported outcomes. Safety was measured by the number of self-reported complications. Differences in safety measures between the subgroups were tested. Results: The analysis included complete data from 81 patients; 30 (37%) receiving OnabotA for the first time, 51 (63%) receiving a repeat injection. Both subgroups reported significant reductions in the use of anticholinergics, more tolerable bladder symptoms, and improvements in patient-reported outcomes. Dry rates were similarly high in both groups (50% and 43%, respectively). There were no statistically significant differences between the subgroups in terms of their safety outcomes. Conclusions: OnabotA is equally as efficacious and safe for patients with overactive bladder receiving a repeat injection as it is for those receiving their first injection.

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Section: Discussioncontrasting

confidence: 96%

Section: Discussionsupporting

confidence: 83%

Section: Introductionmentioning

confidence: 99%

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OnabotulinumtoxinA for the treatment of idiopathic overactive bladder is effective and safe for repeated use

Carlson

Civitarese

Baverstock

2017

CUAJ

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“…Botulinum toxin (type A) is a neurotoxin that inhibits the release of acetylcholine from the presynaptic cholinergic nerve ending, which decreases the muscle contractibility owing to localized chemical denervation (Nitti et al;EMBARK Study Group, 2013 andAndersson et al, 2009). Botulinum toxin type A has been shown to reduce urinary symptoms of OAB by 35-50% compared with placebo (NICE, 2015a).…”

Section: Botulinum Toxinmentioning

confidence: 99%

An overview of urinary incontinence

Bardsley

2016

Br J Nurs

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Urinary incontinence is a common problem that is often under-reported due to the embarrassing nature and social stigma attached. Urinary incontinence can have a considerable effect on an individual's quality of life, but can be significantly improved with correct assessment, treatment and management. Conservative treatment options including: pelvic floor exercises, bladder retraining and fluid modification are recommended before referral to secondary services. This article provides an overview of the main types of urinary incontinence, and summarises recent guidelines for the assessment, diagnosis and effective conservative treatment options for them and when a referral for specialist care is required.

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“…2), micturition, urgency and nocturia episodes. 40 Other researchers have shown that efficacy outcomes among responders are sustained after repeated injections, 41 and that persistence …”

Section: New Drugs For Oabmentioning

confidence: 99%

Highlights of the University of Toronto Urology Update 2014

Herschorn

2015

CUAJ

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At the University of Toronto Urology Update 2014, a faculty of Canadian and American experts presented a series of lectures covering a range of topics in the field of urology. Areas of focus included prostate cancer (PCa), functional urology, erectile dysfunction (ED), and surgical topics (e.g., percutaneous nephrolithotomy [PCNL]). Prostate cancer screening in 2014: The debate rages on Highlights of presentations by Drs. Neil Fleshner, Girish Kulkarni, Anthony Miller and H. Ballentine CarterThe utility of the serum prostate-specific antigen (PSA) test for the early detection of PCa has been the subject of vigorous debate among clinicians, researchers and policy-makers. As discussed at Urology Update 2014, authors of current and recent guidelines still do not agree on whether or not screening should be offered on a population basis.

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OnabotulinumtoxinA for the Treatment of Patients with Overactive Bladder and Urinary Incontinence: Results of a Phase 3, Randomized, Placebo Controlled Trial

Abstract: OnabotulinumtoxinA 100 U showed significant, clinically relevant improvement in all overactive bladder symptoms and health related quality of life in patients inadequately treated with anticholinergics and was well tolerated.

Cited by 348 publications

References 21 publications

OnabotulinumtoxinA for the treatment of idiopathic overactive bladder is effective and safe for repeated use

OnabotulinumtoxinA for the treatment of idiopathic overactive bladder is effective and safe for repeated use

An overview of urinary incontinence

Highlights of the University of Toronto Urology Update 2014

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