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

Overactive bladder affects 12% to 17% of the general population and almost a third experience urinary incontinence, which may severely impact health related quality of life. Oral anticholinergics are the mainstay of pharmacological treatment but they are limited by inadequate efficacy or side effect...

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Veröffentlicht in:The Journal of urology Jg. 197; H. 2S; S. S216
Hauptverfasser: Nitti, Victor W, Dmochowski, Roger, Herschorn, Sender, Sand, Peter, Thompson, Catherine, Nardo, Christopher, Yan, Xiaohong, Haag-Molkenteller, Cornelia
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States 01.02.2017
Schlagworte:
Acetylcholine Release Inhibitors - administration & dosage
Acetylcholine Release Inhibitors - adverse effects
Aged
Botulinum Toxins, Type A - administration & dosage
Botulinum Toxins, Type A - adverse effects
Cholinergic Antagonists - therapeutic use
Female
Humans
Injections, Intramuscular
Male
Middle Aged
Neuromuscular Agents - administration & dosage
Neuromuscular Agents - adverse effects
Urinary Bladder - drug effects
Urinary Bladder, Overactive - complications
Urinary Bladder, Overactive - drug therapy
Urinary Incontinence - drug therapy
Urinary Incontinence - etiology
Urinary Retention - chemically induced
Urinary Tract Infections - chemically induced
injections
overactive
urinary bladder
intramuscular
botulinum toxins
onabotulinumtoxinA
urinary incontinence
ISSN:1527-3792, 1527-3792
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Zusammenfassung:Overactive bladder affects 12% to 17% of the general population and almost a third experience urinary incontinence, which may severely impact health related quality of life. Oral anticholinergics are the mainstay of pharmacological treatment but they are limited by inadequate efficacy or side effects, leading to a high discontinuation rate. We report the results of the first large (557 patients), phase 3, placebo controlled trial of onabotulinumtoxinA in patients with overactive bladder and urinary incontinence inadequately managed with anticholinergics. Eligible patients with overactive bladder, 3 or more urgency urinary incontinence episodes in 3 days and 8 or more micturitions per day were randomized 1:1 to receive intradetrusor injection of onabotulinumtoxinA 100 U or placebo. Co-primary end points were the change from baseline in the number of urinary incontinence episodes per day and the proportion of patients with a positive response on the treatment benefit scale at posttreatment week 12. Secondary end points included other overactive bladder symptoms and health related quality of life. Adverse events were assessed. OnabotulinumtoxinA significantly decreased the daily frequency of urinary incontinence episodes vs placebo (-2.65 vs -0.87, p <0.001) and 22.9% vs 6.5% of patients became completely continent. A larger proportion of onabotulinumtoxinA than placebo treated patients reported a positive response on the treatment benefit scale (60.8% vs 29.2%, p <0.001). All other overactive bladder symptoms improved vs placebo (p ≤0.05). OnabotulinumtoxinA improved patient health related quality of life across multiple measures (p <0.001). Uncomplicated urinary tract infection was the most common adverse event. A 5.4% rate of urinary retention was observed. 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.
Bibliographie:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
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ISSN:1527-3792
1527-3792
DOI:10.1016/j.juro.2016.10.109