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Principal Investigator:  Kathryn Hirst, Ph.D.

Success with botulinum toxin to treat non-prostate symptoms of the lower urinary tract provided evidence that botulinum toxin may offer relief of lower urinary tract symptoms attributed to BPH. The primary objective of this phase II trial is to determine whether two different doses of botulinum toxin injection into the prostate gland demonstrate sufficient improvement in the management of lower urinary symptoms due to BPH to warrant more extensive research. This is a non-comparative phase II study in which patients are randomized to one of two doses of botulinum toxin, either a 100 U dose or a 300 U dose. An optimal two-stage design is applied to determine whether there is sufficient activity at either of the two dose levels to warrant further investigation. The response rate or proportion of patients treated successfully is examined in two stages. The decision of whether or not to terminate after the first stage is based on the number of responses observed for the patients in the first stage. The procedure is termed 'non-comparative' because the two dose levels are not compared to each other but to a pre-determined critical cut-off value. Patients are recruited and treated at 7 clinical centers and followed for 12 months after treatment. In stage 1, 48 patients are randomized to the 2 dose levels, and in stage 2, 78 more patients are randomized, for a total of 126 patients.)