OBJECTIVES To examine the effects of the antimuscarinic agent solifenacin on urinary urgency, using a range of novel and established outcome measures, as urgency is the principal symptom of the overactive bladder syndrome (OAB). PATIENTS AND METHODS The study (SUNRISE, solifenacin in the treatment of urgency symptoms of OAB in a rising dose, randomized, placebo‐controlled, double‐blind, efficacy trial) was a randomized, double‐blind, 16‐week, placebo‐controlled, multicentre study of solifenacin 5/10 mg in 863 patients with symptoms of OAB for ≥3 months. The primary efficacy variable was the change from baseline to endpoint in the number of episodes of severe urgency with or without urgency incontinence per 24 h, as measured using the Patient Perception of Intensity of Urgency Scale, grade 3 + 4. Secondary efficacy variables included patient‐reported outcomes for bladder condition, urgency bother and treatment satisfaction. A 3‐day voiding diary was used to record micturition frequency and episodes of urgency and incontinence. A 7‐day diary was used to assess speed of onset of effect. RESULTS Solifenacin 5/10 mg was significantly more effective than placebo in reducing the mean number of episodes of severe urgency with or without incontinence per 24 h from baseline to endpoint (−2.6 vs −1.8, P < 0.001). There were also statistically significant differences in favour of solifenacin 5/10 mg over placebo for all secondary variables measured at endpoint, including patient‐reported outcomes. There was a significant improvement in urgency as early as day 3 of treatment. Treatment‐emergent adverse events with solifenacin 5/10 mg were mainly mild or moderate in severity, and only led to discontinuation in 3.6% of patients. CONCLUSION Solifenacin significantly reduced the number of urgency episodes and the extent of urgency bother, and was well tolerated; it was effective as early as day 3 of treatment.

OBJECTIVESTo evaluate the dose-response relationship and safety/tolerability of solifenacin succinate (YM905) in the treatment of overactive bladder (OAB), and to compare its efficacy and safety/tolerability with tolterodine 2 mg twice daily. PATIENTS AND METHODSThis multicentre study included a 2-week single-blind placebo run-in, a 4-week doubleblind placebo-controlled active treatment phase, and a 2-week follow-up. Men and women with an OAB and urodynamic evidence of detrusor overactivity were randomized to placebo or solifenacin 2.5, 5, 10 or 20 mg once daily, or tolterodine 2 mg twice daily. RESULTSOf 265 patients enrolled, 225 were randomized and 192 completed the study. Solifenacin 5, 10 and 20 mg produced statistically significant ( P < 0.05) improvements in voids/24 h vs placebo, whereas tolterodine did not; the mean change with tolterodine was between those with solifenacin 2.5 and 5 mg. The outcome was similar for the mean change from baseline to endpoint in mean volume voided/void. For incontinence and urgency episodes/24 h the solifenacin dose groups showed numerically superior changes vs placebo; the mean effects with tolterodine were generally smaller than with solifenacin. Most of the efficacy effect of solifenacin was evident at 2 weeks. Qualityof-life outcomes supported the efficacy results. Solifenacin 5 and 10 mg were well tolerated; there were no serious treatmentrelated adverse events. The incidence of dry mouth was 14% for solifenacin 5 and 10 mg, 2.6% for placebo and 24% for tolterodine. CONCLUSIONIn this study, the 5-and 10-mg doses of solifenacin appeared to be the most clinically effective for treating OAB, considering the Early results using two new agents to treat urinary incontinence are published. The use of Ro 115-1240 in women with stress urinary incontinence is presented, with encouraging results. This will lead to further studies in more patients.Solifenacin was evaluated in a dose-finding study and the results presented here; the results of the phase III study appear next month. balance between efficacy, quality of life and tolerability. From the results of this study solifenacin 5 and 10 mg were selected for further evaluation in large-scale phase 3 studies.

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Morphometric differences in detrusor muscle cell diameter and the connective tissue-to-smooth muscle ratio were observed between controls and patients with obstruction. There is an increase in detrusor muscle cell diameter and fibrosis in bladder outlet obstruction and more intense intrafascicular collagen deposition in patients in acute urinary retention.