BJU international
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Randomized Controlled Trial Multicenter Study Clinical Trial
Efficacy and safety of tadalafil in a Western European population of men with erectile dysfunction.
To evaluate, in a randomized, double-blind, placebo-controlled, multicentre trial, the safety and efficacy of on-demand tadalafil (an oral phosphodiesterase type-5 inhibitor approved in many countries for treating erectile dysfunction, ED) in a Western European population of men with mild-to-severe ED. ⋯ Tadalafil improved erectile function and was well tolerated when taken by men from Western Europe with mild-to-severe ED.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Randomized, double-blind placebo- and tolterodine-controlled trial of the once-daily antimuscarinic agent solifenacin in patients with symptomatic overactive bladder.
To assess in a phase 3a trial the efficacy of solifenacin succinate, a once-daily oral antimuscarinic agent in development at 5-mg and 10-mg dosage strengths, for the treatment of overactive bladder (OAB) (Yamanouchi Pharmaceutical Co. Ltd, Tokyo, Japan) compared with placebo in patients with symptoms of OAB, i.e. urgency, incontinence, and frequency, with additional objectives being to assess the safety and tolerability of solifenacin and to compare the efficacy and safety of solifenacin with tolterodine 2 mg twice daily. ⋯ Solifenacin 5 and 10 mg once daily improved urgency and other symptoms of OAB, and was associated with an acceptable level of anticholinergic side-effects. Solifenacin demonstrated significantly favourable efficacy to side-effect ratio in treating symptomatic OAB.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Duloxetine vs placebo in the treatment of stress urinary incontinence: a four-continent randomized clinical trial.
To further assess, in a phase 3 study, treatment with duloxetine for women with stress urinary incontinence (SUI) in other geographical regions, including Argentina, Australia, Brazil, Finland, Poland, South Africa and Spain, as previous trials in North America and Europe provided evidence for the safety and efficacy of duloxetine as a pharmacological treatment for SUI in women. ⋯ These results show improvements in incontinence and quality of life with duloxetine 40 mg twice daily for 12 weeks that are in keeping with those reported in two other recently completed phase 3 trials in Europe and North America.
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Randomized Controlled Trial Multicenter Study Clinical Trial
The effect of drotaverine hydrochloride in acute colicky pain caused by renal and ureteric stones.
To assess the spasmolytic effect of drotaverine hydrochloride in colicky pain caused by renal and ureteric stones. ⋯ Intravenous drotaverine provides effective pain relief in more than two-thirds of patients with renal colic, with no serious side-effects.
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Randomized Controlled Trial Comparative Study Clinical Trial
Assessment of an electronic daily diary in patients with overactive bladder.
To assess the effectiveness of a portable electronic diary as a data collection device for overactive bladder symptoms, and to evaluate its level of patient acceptability compared with a conventional paper-based voiding diary. ⋯ We confirmed that the electronic diary is a novel method of collecting clinically relevant symptom data from patients with an overactive bladder. In addition, the ease-of-use ratings support the use of the electronic diary as a superior alternative to paper diaries, providing real-time data which can be rapidly analysed, and thus allowing a speedy review of data during ongoing clinical studies.