Adult urologyComparative efficacy and safety of transdermal oxybutynin and oral tolterodine versus placebo in previously treated patients with urge and mixed urinary incontinence☆
Section snippets
Study population
The institutional review boards approved the study protocol, and all patients gave written informed consent. Patients eligible for inclusion included men and women at least 18 years of age taking current pharmacologic treatment for OAB. A beneficial response to the prestudy treatment was required, established only by patient report and investigator assessment of current treatment. After a washout period, the baseline, 3-day urinary diary requirements included four or more urge urinary
Results
A total of 361 patients were randomized to treatment, and 320 (89%) completed the double-blind period. The treatment groups were comparable with respect to demographic and disease characteristics and prior antimuscarinic treatment (Table I). The median duration of prior treatment was longer than 1 year (range 6 weeks to 20 years).
Treatment compliance with the assigned dosage regimen was 92%, with no specific reasons for lack of compliance. Transdermal systems adhered completely in 92% of
Comment
This study demonstrated comparable improvements in OAB symptoms between transdermal oxybutynin and long-acting tolterodine and the superiority of both treatments over placebo. The low overall incidence of anticholinergic side effects was a result of the requirement for beneficial prestudy antimuscarinic treatment, selectively excluding patients with intolerable side effects.
The improvement in incontinence episodes in the present study was comparable to the findings in previous reports during
Conclusions
The twice-weekly application of OXY-TDS was effective and safe and improved the quality of life during chronic treatment of patients with OAB. Efficacy was comparable to long-acting tolterodine and systemic safety, including anticholinergic adverse events, was improved compared with that of tolterodine. Local application site reactions, unique to transdermal treatment, should be expected to occur in some patients. These reactions are generally transient and self-limiting, mild to moderate
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Placebo Response in Patients with Oral Therapy for Overactive Bladder: A Systematic Review and Meta-analysis
2022, European Urology FocusBasic and clinical aspects of antimuscarinic agents used to treat overactive bladder
2018, Pharmacology and TherapeuticsCitation Excerpt :This apparent similar efficacy was supported in a separate review of 49 trials encompassing >11,000 patients, in which the authors found no significant differences in patient-perceived improvements, leakage episodes, or voids in 24 h among patients treated with oxybutynin versus those treated with tolterodine (Hay-Smith et al., 2005). The efficacy of oxybutynin IR at different doses administered orally or transdermally was evaluated by Davila et al. (2001), while Dmochowski et al. (2003) compared the efficacy of transdermal oxybutynin at 3.9 mg once daily with tolterodine ER at 4 mg once daily. A meta-analysis of efficacy showed similar reductions in the number of incontinence episodes in 24 h in both studies (Novara et al., 2008; Asimakopoulos et al., 2012).
N<sup>o</sup> 283-Traitements visant la vessie hyperactive: Accent sur la pharmacothérapie
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This study was funded by Watson Pharma.
R. R. Dmochowski, P. K. Sand, N. R. Zinner, M. C. Gittelman, and G. W. Davila are study investigators funded by, and members of the medical advisory board to, the sponsor. S. W. Sanders is an employee of the sponsor.