Efficacy and Safety of Oxybutynin Chloride Topical Gel for Overactive Bladder: A Randomized, Double-Blind, Placebo Controlled, Multicenter Study

Staskin, David R.; Dmochowski, Roger R.; Sand, Peter K.; MacDiarmid, Scott; Caramelli, Kim E.; Thomas, Heather; Hoel, Gary

doi:10.1016/j.juro.2008.11.125

Cited by 98 publications

(80 citation statements)

References 16 publications

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“…OTG significantly reduced the number of daily incontinence episodes (mean decrease, -3.0 versus placebo, -2.5; P , 0.0001, Figure 3) and daily micturitions (mean decrease, -2.7 versus placebo, -2.0; P = 0.0017) and significantly increased voided volume (mean increase, 21.0 mL versus placebo, 3.8 mL; P = 0.0018). 16 Although changes from baseline in the daily number of nocturia events did not differ significantly between treatments in the total study population, patients younger than 65 years achieved significant decreases Table 4); no application-site erythema was observed …”

Section: Clinical Efficacymentioning

confidence: 86%

“…16,22 A 12-week, double-blind, placebo-controlled Phase III study of OTG enrolled 789 patients with urge or mixed urinary incontinence, many of whom had severe OAB symptoms. The mean number of daily urinary incontinence and nocturia episodes at baseline was 5.4 and 2.5, respectively.…”

Section: Clinical Efficacymentioning

confidence: 99%

“…16 Of the 389 patients treated with OTG, 5.4% reported application-site skin reactions adverse events (versus 1.0% for placebo) and 2.1% developed application-site pruritus adverse events (versus 0.8%, placebo; Table 6). Application-site skin reactions were given as a reason for treatment discontinuation by three patients (0.8%) in the OTG group and one patient (0.3%) in the placebo group.…”

Section: Steady-state Pharmacokinetics Of Otg Versus Oxy-tdsmentioning

confidence: 99%

“…15 Results of a large placebo-controlled Phase III study demonstrated that OTG is efficacious and well tolerated, with low incidences of anticholinergic adverse events and application-site skin reactions. 16 Here, we review the development of OTG, provide previously unpublished data, and discuss its unique formulation and pharmacokinetic properties in the context of available clinical efficacy and tolerability data.…”

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confidence: 99%

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Development of oxybutynin chloride topical gel for overactive bladder

Lucente

De²

2011

RRU

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Overactive bladder (OAB) is an age-related syndrome often associated with urinary incontinence. Symptoms of OAB, such as urgency, frequency, and nocturia, can be treated effectively with inhibitors of muscarinic acetylcholine receptors. Antimuscarinic agents promote relaxation of the detrusor muscle and may modulate afferent neuronal signals involved in the regulation of the micturition reflex. Despite the availability of an increasing number of oral antimuscarinic agents, treatment persistence among patients with OAB generally appears to be low. This may be attributed, at least in part, to the common occurrence of anticholinergic adverse effects, such as dry mouth, constipation, and dizziness. Oxybutynin is a well-established antimuscarinic agent that is available in a variety of formulations. Transdermal formulations have been developed to avoid the first-pass hepatic and gastrointestinal drug metabolism responsible for the anticholinergic adverse effects often observed with oral delivery of oxybutynin. Oxybutynin chloride topical gel (OTG) is a formulation of oxybutynin that was approved by the US Food and Drug Administration in January 2009. OTG was the result of a systematic evidence-based effort to develop a formulation that preserves the efficacy of oral oxybutynin formulations while eliminating most of their anticholinergic adverse effects. Additional emphasis was put on creating a transdermal formulation with minimal potential for application-site skin reactions. The formulation and pharmacokinetic properties of OTG are reviewed in the context of recently published efficacy and tolerability data from a large multicenter, placebo-controlled Phase III study.

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Section: Clinical Efficacymentioning

confidence: 86%

Section: Clinical Efficacymentioning

confidence: 99%

Section: Steady-state Pharmacokinetics Of Otg Versus Oxy-tdsmentioning

confidence: 99%

mentioning

confidence: 99%

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Development of oxybutynin chloride topical gel for overactive bladder

Lucente

De²

2011

RRU

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“…73 The use of oxybutynin topical gel has been investigated in a large North American multicentre randomised, placebocontrolled study of 789 patients with OAB. 74 Overall oxybutynin gel was associated with a significant decrease in urge incontinence episodes and urinary frequency when compared to placebo with a corresponding increase in voided volume. Propiverine hydrochloride is an antimuscarinic with Ca 2+ channel antagonism activity.…”

Section: Drugs With Mixed Actionsmentioning

confidence: 91%