TY - JOUR
T1 - Effects of 100 and 300 units of onabotulinum toxin A on lower urinary tract symptoms of benign prostatic hyperplasia
T2 - A phase II randomized clinical trial
AU - Crawford, E. David
AU - Hirst, Kathryn
AU - Kusek, John W.
AU - Donnell, Robert F.
AU - Kaplan, Steven A.
AU - McVary, Kevin T.
AU - Mynderse, Lance A.
AU - Roehrborn, Claus
AU - Smith, Christopher P.
AU - Bruskewitz, Reginald
N1 - Funding Information:
Supported by NIDDK/NIH Grants U01 DK60791 (University of Colorado Denver), U01 DK60795 (Northwestern University), U01 DK60799 (University of Texas Southwestern Medical Center), U01 DK60803 (Medical College of Wisconsin), U01 DK60804 (Cornell University), U01 DK060810 (Baylor College of Medicine), U01 DK60813 (Mayo Clinic) and U01 DK60817 (George Washington University).
PY - 2011/9
Y1 - 2011/9
N2 - Purpose: We conducted a 2-stage, multicenter, double-blind, randomized phase II clinical trial of 100 and 300 unit doses of onabotulinum toxin A to treat the lower urinary tract symptoms of benign prostatic hyperplasia. Materials and Methods: Men 50 years old or older with clinically diagnosed benign prostatic hyperplasia, American Urological Association symptom index 8 or greater, maximum urinary flow rate less than 15 ml per second, voided volume 125 ml or greater, and post-void residual 350 ml or less were randomized to prostatic transrectal injection of 100 or 300 units of onabotulinum toxin A. The primary outcome was at least 30% improvement from baseline to 3 months in American Urological Association symptom index and/or maximum urinary flow rate and safety. The men were followed for 12 months. Results: A total of 134 men were randomized and treated (68 with 100 units, 66 with 300 units), with 131 assessed at 3 months and 108 assessed at 12 months. Each dose met the 3-month primary outcome criteria. In the 100 unit arm the mean baseline American Urological Association symptom index of 18.8 decreased by 7.1 and 6.9 at 3 and 12 months, respectively. In the 300 unit arm the baseline of 19.5 decreased by 8.9 and 7.1, respectively. In the 100 unit arm the mean baseline maximum urinary flow rate of 10.0 ml per second increased by 2.5 and 2.2, respectively, and in the 300 unit arm the baseline of 9.6 increased by 2.6 and 2.3, respectively. Conclusions: The intraprostatic injection of 100 or 300 units of onabotulinum toxin A passed predetermined criteria for treatment efficacy and safety, and a randomized trial with either dose is warranted. The 100 unit dose may be preferable due to similar efficacy with reduced costs and adverse effects.
AB - Purpose: We conducted a 2-stage, multicenter, double-blind, randomized phase II clinical trial of 100 and 300 unit doses of onabotulinum toxin A to treat the lower urinary tract symptoms of benign prostatic hyperplasia. Materials and Methods: Men 50 years old or older with clinically diagnosed benign prostatic hyperplasia, American Urological Association symptom index 8 or greater, maximum urinary flow rate less than 15 ml per second, voided volume 125 ml or greater, and post-void residual 350 ml or less were randomized to prostatic transrectal injection of 100 or 300 units of onabotulinum toxin A. The primary outcome was at least 30% improvement from baseline to 3 months in American Urological Association symptom index and/or maximum urinary flow rate and safety. The men were followed for 12 months. Results: A total of 134 men were randomized and treated (68 with 100 units, 66 with 300 units), with 131 assessed at 3 months and 108 assessed at 12 months. Each dose met the 3-month primary outcome criteria. In the 100 unit arm the mean baseline American Urological Association symptom index of 18.8 decreased by 7.1 and 6.9 at 3 and 12 months, respectively. In the 300 unit arm the baseline of 19.5 decreased by 8.9 and 7.1, respectively. In the 100 unit arm the mean baseline maximum urinary flow rate of 10.0 ml per second increased by 2.5 and 2.2, respectively, and in the 300 unit arm the baseline of 9.6 increased by 2.6 and 2.3, respectively. Conclusions: The intraprostatic injection of 100 or 300 units of onabotulinum toxin A passed predetermined criteria for treatment efficacy and safety, and a randomized trial with either dose is warranted. The 100 unit dose may be preferable due to similar efficacy with reduced costs and adverse effects.
KW - onabotulinum toxin A
KW - prostatic hyperplasia
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U2 - 10.1016/j.juro.2011.04.062
DO - 10.1016/j.juro.2011.04.062
M3 - Article
C2 - 21791356
AN - SCOPUS:80051552892
SN - 0022-5347
VL - 186
SP - 965
EP - 970
JO - Journal of Urology
JF - Journal of Urology
IS - 3
ER -