International Journal of Urology (2006) 13, 692–698 Blackwell Publishing AsiaMelbourne, AustraliaIJUInternational Journal of Urology0919-81722006 Blackwell Publishing Asia Pty LtdJune 2006136692698Original Article Comparison of properine and oxybutynin P Abrams et al. Correspondence: Dzelal Serdarevic MD, Pfizer Global Research & Development, Sandwich Laboratories UK Ramsgate Road, Sandwich, Kent CT139NJ, United Kingdom. Email: dzelal.serdarevic@pfizer.com Received 18 May 2005; accepted 15 November 2005. *Multicentre Principal Investigators from the United King- dom: Paul Abrams, Bristol Urologic Institute, Bristol; Linda Cardozo, Kings College Hospital, London; Christopher Chap- ple, Royal Hallamshire Hospital, Sheffield; Robert Freeman, Derriford Hospital, Plymouth; Sahed Taseem Hasan, Freeman Hospital, Newcastle upon Tyne; Vikram Khullar, Imperial College School of Medicine, London; Marek Miller, Northampton General Hospital, Cliftonville; Brian Wise, Wil- liam Harvey Hospital, Ashford. Original Article Comparison of the efficacy, safety, and tolerability of propiverine and oxybutynin for the treatment of overactive bladder syndrome PAUL ABRAMS, 1 LINDA CARDOZO, 2 CHRISTOPHER CHAPPLE, 3 DZELAL SERDAREVIC, 4 KATHERINE HARGREAVES 4 AND VIKRAM KHULLAR 5 AND THE 1032 STUDY GROUP* 1 Bristol Urologic Institute, Bristol, 2 Department of Women’s Health, King’s College Hospital, London, 3 Department of Urology, Royal Hallamshire Hospital, Sheffield, 4 Pfizer Global Research and Development, Sandwich, and 5 Department of Obstetrics and Gynaecology, Imperial College School of Medicine, London, UK Aim: To compare the effects of propiverine and oxybutynin on ambulatory urodynamic monitoring (AUM) parameters, safety, and tolerability in patients with overactive bladder. Methods: This was a randomized, double-blind, placebo-controlled, multicentre, crossover study. Patients (n = 77) received two of the following treatments during two 2-week periods: propiverine 20 mg once daily, propiverine 15 mg three times daily, oxybutynin 5 mg three times daily, and placebo. AUM parameters, salivary flow, visual near point, and heart rate were assessed. Results: A consistent order in the efficacy between active treatment groups was observed for the reduction in mean involuntary detrusor contractions (IDCs; oxybutynin 15 mg ≤ propiverine 45 mg ≤ propiverine 20 mg). Differences between the oxybutynin and propiverine 20 mg groups were statistically significant for several AUM endpoints. Statistically significant differences between the oxybutynin and both propiverine groups were also noted in salivary flow rate and heart rate (oxybutynin 15 mg < both propiverine regimens) and in heart rate variability (both propiverine regimens < oxybutynin 15 mg). All active treatments length- ened visual near point. The incidence of dry mouth was significantly more pronounced in the oxybutynin group than in either propiverine group. Treatment with propiverine 45 mg resulted in the highest rates of constipation, lengthening of the visual near point, and effects on heart rate. Conclusions: Oxybutynin 15 mg was more effective than propiverine 20 mg in reducing symptomatic and asymptomatic IDCs in ambulatory patients. The primary differences between the two drugs were the incidence and type of adverse events, which varied with the antimuscarinic receptor specificity of each agent. Key words ambulatory urodynamic monitoring, overactive bladder, oxybutynin, propiverine, safety. Introduction Overactive bladder (OAB) is highly prevalent yet often underdiagnosed and undertreated. 1 The symptoms of OAB are characterized by urgency with or without urgency incontinence, usually with frequency, and nocturia. 2 All age groups and both sexes can be severely affected by OAB, and the prevalence of OAB symptoms generally increases with age. 3 OAB is as prevalent in men as in women, although the manifestation of symptoms is differ- ent; men experience more urgency, and women have more urgency incontinence. 3 Antimuscarinics are a first-line treatment for OAB, but some of these drugs are accompanied by bothersome side- effects, especially dry mouth. 4,5 Oxybutynin and propiver- ine are mixed action agents having antimuscarinic and spasmolytic properties. Clinical trials have shown that oxy- butynin is an effective treatment for OAB. 6–9 However, because oxybutynin is more selective for the salivary gland than the bladder, 10 patients experience a high rate of dry mouth compared with those treated with antimuscarinics that are more selective for the bladder. 5,10–12 Propiverine is also effective in treating OAB, 13–15 but comparisons of effi- cacy results with those from other antimuscarinics are dif- ficult because of differences in study design and efficacy assessment. One placebo-controlled study that used cys- tometry as the primary efficacy assessment of OAB in a clinical setting reported comparable efficacy between propiverine and oxybutynin; however, patients who took propiverine had a lower incidence and decreased severity of dry mouth than did those who took oxybutynin. 13