International drug study shows rapid improvement in overactive bladder symptoms

Patients with overactive bladders who took part in a multi-centre study to measure the effectiveness of solifenacin noticed improvements in as little as three days, according to research published in the November issue of BJU International.

Just over a hundred urology centres from 14 countries took part in the study of 863 patients led by Professor Linda Cardozo from the Department of Urogynaecology at King's College Hospital in London.

During the 16-week double-blind randomised study, neither the researchers nor the patients were aware of which were taking solifenacin and which were taking the placebo or dummy drug. Three times as many patients took the active drug as the placebo.

The aim of the study was to see what effect the drug had on overactive bladder problems, in which patients feel an urgent need to pass urine and some can become incontinent. A number of novel and subjective outcome measures were used to assess urgency.

"This is the first study to assess urgency as the primary endpoint using the Patient Perception of Intensity and Urgency Scale (PPIUS), which ranges from zero to four with grades three and four representing urgency and urgency incontinence" explains Professor Cardozo.

"We also used the six-point Patients Perception of Bladder Condition score, visual analogue scales and patient diaries."

Researchers found that on average patients taking solifenacin reported a 70 per cent reduction in severe urgency and urgency with incontinence, as measured by the PPIUS, compared with 50 per cent 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.

The clinicians taking part in the study reported that they recorded significant improvements in the patients taking solifenacin when they attended their one-week clinic visit after starting to take the drug.

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

"Less than four per cent of the patients reported mild or moderately severe side effects when they took 5mg or 10mg doses of the drug and just 3.6 per cent of the solifenacin group stopped taking the drug.

"Looking at the solifenacin study group as a whole, just under 16 per cent reported dry mouth problems and seven per cent reported constipation.

"Just over two per cent of patients on the placebo also reported side effects. Three per cent reported dry mouth problems and two per cent reported constipation.

"It is common to notice a quite strong placebo effect in overactive bladder trials and this study is no exception. However, even a relatively small difference between active treatment and placebo outcomes might have a large influence on quality of life and treatment success."