Comparative efficacy and safety of transdermal oxybutynin and oral tolterodine versus placebo in previously treated patients with urge and mixed urinary incontinence

Dmochowski, Roger R.; Sand, Peter K.; Zinner, Norman R.; Gittelman, Marc; Davila, G. Willy; Sanders, Steven W.

doi:10.1016/s0090-4295(03)00356-x

Cited by 255 publications

(156 citation statements)

References 14 publications

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“…16 Dry mouth was the only treatment-related anticholinergic adverse event that occurred in more than 2% of patients who received OTG and the only one that occurred significantly more often with OTG than with placebo (OTG, 6.9%; placebo, 2.8%; P = 0.006); headache, dizziness, and constipation occurred rarely ( Table 6). The overall incidence of dry mouth reported for OTG was similar to that observed for OXY-TDS in two placebo-controlled Phase III studies 22,25 and was substantially smaller than that reported for oral oxybutynin in comparable studies. 14 …”

Section: Anticholinergic Adverse Effectssupporting

confidence: 68%

“…OXY-TDS has been shown to be efficacious and associated with low incidences of anticholinergic adverse events, but results of clinical studies in patients with OAB, including a community-based openlabel study, indicated that OXY-TDS can cause pruritus, erythema, and contact dermatitis in a minority of treated patients. 22,25,26 Notably, in a placebo-controlled study of OXY-TDS in patients with OAB, application-site pruritus was observed not only in 16.8% of patients who received oxybutynin patches but also in 6.1% of those who received placebo patches. 22 This suggested that skin occlusion, desquamation, and delayed contact sensitization possibly caused by patch materials may be major factors contributing to the relatively high incidence of application-site skin reactions with OXY-TDS.…”

Section: Skin Tolerabilitymentioning

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: Anticholinergic Adverse Effectssupporting

confidence: 68%

Section: Skin Tolerabilitymentioning

confidence: 99%

Development of oxybutynin chloride topical gel for overactive bladder

Lucente

De²

2011

RRU

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show abstract

“…In a randomized placebo-controlled trial, Zobrist et al (2001) showed that daily incontinence episodes of OAB were reduced markedly by use of an oxybutynin transdermal patch (OXY-TDS). Nevertheless, some studies have revealed that OXY-TDS can cause application-site reactions such as erythema, pruritus and dermatitis (Dmochowski et al, 2003;Sand et al, 2007;Radomski & Barkin, 2012). US Food and Drug Administration approved an oxybutynin chloride (OC) topical gel in January 2009.…”

Section: Introductionmentioning

confidence: 99%

Transdermal delivery of oxybutynin chloride proniosomal gels for the treatment of overactive bladder

et al. 2015

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Context: Overactive bladder (OAB) is a common problem and anticholinergic drugs are first-line therapy, but they have side effects. Objective: Development of oxybutynin chloride (OC) proniosomal gels and analyses of its efficacy for OAB treatment. Materials and methods: Phase separation coacervation was used to prepare proniosomal gels using various non-ionic surfactants, lipids, soy lecithin and isopropyl alcohol. Gels were characterized with regard to entrapment efficiency (EE), vesicle size, surface morphology (using environmental scanning electron microscopy [E-SEM]), stability, attenuated total reflectance Fourier transform infrared (ATR-FTIR) spectroscopy, in vitro skin permeation, in vivo animal studies and histopathology. Results and discussion: EE was 87-92%, vesicle size was 0.38-5.0 mm, and morphology showed some loosened pores in proniosomes after hydration. ATR-FTIR spectroscopy showed no significant shifts in peaks corresponding to OC and excipients. Most formulations exhibited 450% permeation but the cholesterol-containing formulations P3 (Span 20:Span 60 [1:1]) and P4 [Tween 20:Tween 80 (1:1)] had the highest percent cumulative permeation. P3 and P4 also showed faster recovery of cholinergic effects on salivary glands than oral formulations. P3 and P4 had pronounced therapeutic effects in reduction of urinary frequency and demonstrated improvements in bladder morphology (highly regenerative surface of the transitional epithelium). Conclusion: These results suggest that OC could be incorporated into proniosomal gels for transdermal delivery in the treatment of OAB.

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“…Oxybutynin is also available in a transdermal formulation, 42 which may be considered for patients who are unlikely to adhere to oral therapy or who dislike multiple-dose daily regimens. Because transdermal oxybutynin does not undergo the first-pass metabolism in the liver, much lower concentrations of N-desethyloxybutynin (the responsible active metabolite for the anticholinergic side effects) are observed.…”

Section: Antimuscarinic Treatmentmentioning

confidence: 99%

Treatment of Overactive Bladder in Elderly Patients: Clinical Considerations

2015

Clinical Medicine Insights: Geriatrics

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Overactive bladder (OAB) is a highly prevalent disorder among elderly and frail elderly patients, who are frequently polymedicated, suffer from kidney and liver failure and are susceptible to adverse events. Particular attention is, therefore, being given to efficacy and side effects of the treatment in patients older than 75 years. The introduction of newly developed drugs specifically designed for the treatment of OAB is opening new frontiers on this respect. The authors summarize the most recent evidence on this topic.

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Comparative efficacy and safety of transdermal oxybutynin and oral tolterodine versus placebo in previously treated patients with urge and mixed urinary incontinence

Cited by 255 publications

References 14 publications

Development of oxybutynin chloride topical gel for overactive bladder

Development of oxybutynin chloride topical gel for overactive bladder

Transdermal delivery of oxybutynin chloride proniosomal gels for the treatment of overactive bladder

Treatment of Overactive Bladder in Elderly Patients: Clinical Considerations

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