Effects of 100 and 300 Units of Onabotulinum Toxin A on Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: A Phase II Randomized Clinical Trial
Year: 2011
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: 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.
Source: The Journal of Urology
Institutions: University of Colorado Anschutz, University of Colorado Denver, George Washington University, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Medical College of Wisconsin, Cornell University, Northwestern University, Mayo Clinic, The University of Texas Southwestern Medical Center, Baylor College of Medicine, University of Wisconsin–Madison
Language: English
Subfield: Urology
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: The Efficacy of TUMT and Neoadjuvant Finasteride for BPH, G1356164907, G1864167910, G3451611862, G3520798814, G4577998997, Medical Versus Minimally Invasive Therapy for BPH, Minimally Invasive Surgical Therapies Consortium for BPH, G6414818773, G6902212921, Minimally Invasive Surgery For BPH, G7432250248, G7991223798, Urodynamic and Multiethnic Variability of Men Treated b*, TUMT verses Medical Therapy in Treatment of BPH
OpenAlex ID: W2027744939