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First-of-Its-Kind Study Shows Botox (Botulinum Toxin Type A),Significantly Improves Idiopathic Detrusor Overactivity (IDO) in,Patients With Symptoms of Overactive Bladder

whom previous treatments had not worked," said Mr. Prokar Dasgupta, consultant urologist at Guy's Hospital, honorary senior lecturer at King's College London, and a co-principal investigator of the study. "These were patients who were seriously affected by their OAB symptoms. At basline, 81 percent of patients in the botulinum toxin type A treatment group and 67 percent in the placebo treatment group were experiencing urge urinary incontinence daily."

OAB is more common than osteoarthritis or diabetes(1,2) and is estimated to affect 16-17% of the population in the U.S. and Western Europe.(3) In addition, the economic burden of OAB is substantial. In the U.S., for example, the total economic cost of OAB has been estimated at $12 billion in 2000 (including costs incurred in the community and institutions).

About the Study

The double-blind trial included 34 patients with OAB and confirmed IDO who had failed on a trial of anticholinergic therapy for six weeks or more due to either poor efficacy or tolerability. They were randomly assigned to treatment with BTX-A 200 U (BOTOX(R)) (16 patients) or placebo (18 patients). The primary outcome measure was change in maximum cystometric capacity (MCC), a measure of urinary bladder capacity. Secondary outcome measures included changes in OAB symptoms, other measures related to urinary bladder filling and pressure, symptoms of urgency and incontinence, and quality of life (QoL). Patients were assessed at 4 and 12 weeks post-injection, at which point the study was unblinded; BTX-A patients were further followed until 24 weeks.

BTX-A treatment significantly increased MCC vs. baseline at 4 weeks (by about 72%) and 12 weeks (by about 45%), compared to a 15 percent decrease in placebo patients at both time points. The differences between MCC changes for the BTX-A and placebo groups were significant at both time points (p<0.0001 and p<0.0011, respectively). Likewise, at 4 and 12 weeks compared to baseline,
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