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Title: Solifenacin Shows Rapid Improvement in Overactive Bladder Symptoms
URL: http://www.pslgroup.com/dg/22E7A2.htm
Doctor's Guide
October 9, 2008

HOBOKEN, NJ -- October 9, 2008 -- Patients with overactive bladders who took part in a multicentre study to measure the effectiveness of solifenacin noticed improvements in as little as 3 days, according to a study published early online and in the November issue of BJU International.

Linda Cardozo, Department of Urogynaecology, King's College Hospital, London, United Kingdom, and colleagues conducted the Solifenacin in the Treatment of Urgency Symptoms of Overactive Bladder in a Rising Dose, Randomised, Placebo Controlled, Double Blind, Efficacy (SUNRISE) trial that included 863 patients from just over 100 urology centres in 14 countries.

During the 16-week study, neither the researchers nor the patients were aware of which were taking solifenacin and which were taking the placebo, but 3 times as many patients took the active drug as the placebo.

Researchers found that on average patients taking solifenacin reported a 70% reduction in severe urgency and urgency with incontinence, as measured by the Patient Perception of Intensity and Urgency Scale, compared with 50% for those taking the placebo. There were also statistically significant improvements when it came to all levels of urgency, maximum urgency intensity, and urgency bother.

"Solifenacin was significantly more effective than the placebo as early as day 3," said Cardozo. "Patients reported that they passed urine less frequently and also reported significant reductions in the number of daily incontinence and urgency incontinence episodes."

Mild or moderately severe side effects were reported in 4% of patients who took solifenacin 5 or 10 mg and 3.6% discontinued use of the drug. Patients on solifenacin reported dry mouth problems (approximately 16%) and constipation (7%) as did patients receiving placebo (3% and 2%, respectively).

The study was carried out in two 8-week segments. In the first 8 weeks 640 patients (74%) were given solifenacin 5 mg QD and the remaining 223 received the placebo. At the end of 8 weeks, 46.5% of patients receiving solifenacin requested a dose increase, as did 66% of patients receiving the placebo.

Half of the patients receiving solifenacin had their doses doubled from 5 to 10 mg, and the other half were left on 5 mg. The results from this secondary analysis will be published at a later date.


SOURCE: Johns Hopkins Medical Institutions

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