Claus G Roehrborn1, Steven N Gange, Neal D Shore, Jonathan L Giddens, Damien M Bolton, Barrett E Cowan, B Thomas Brown, Kevin T McVary, Alexis E Te, Shahram S Gholami, Prem Rashid, William G Moseley, Peter T Chin, William T Dowling, Sheldon J Freedman, Peter F Incze, K Scott Coffield, Fernando D Borges, Daniel B Rukstalis. 1. University of Texas Southwestern Medical Center, Dallas, Texas; Scott and White Healthcare, Temple, Texas; Western Urological Clinic, Salt Lake City, Utah; Carolina Urological Research Center, Myrtle Beach, South Carolina; Cosmetic Surgery Hospital, Brampton, and Oakville Trafalgar Memorial Hospital, Oakville, Ontario, Canada; The Austin Hospital, Melbourne, Victoria, Australia, Urology Associates of Denver, Denver, Colorado; Atlantic Urological Associates, Daytona Beach, and Pinellas Urology, St. Petersburg, Florida; Northwestern University and Southern Illinois University, Springfield, Illinois; Weill Cornell Medical Center, New York, New York; Urology Associates of Silicon Valley, San Jose, and SD Uro-Research, San Diego, California; Port Macquarie Hospital, Port Macquarie, and Figtree Private Hospital, Figtree, New South Wales, Australia; Chesapeake Urology, Baltimore, Maryland; Freedman, MD, LTD, Las Vegas, Nevada; Geisinger Medical Center and Wake Forest University, Winston-Salem, North Carolina. Electronic address: Claus.Roehrborn@UTSouthwestern.edu.
Abstract
PURPOSE: We report the first multicenter randomized blinded trial of the prostatic urethral lift for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. MATERIALS AND METHODS:Men at least 50 years old with AUASI (American Urological Association Symptom Index) 13 or greater, a maximum flow rate 12 ml per second or less and a prostate 30 to 80 cc were randomized 2:1 between prostatic urethral lift and sham. In the prostatic urethral lift group small permanent implants are placed within the prostate to retract encroaching lobes and open the prostatic urethra. Sham entailed rigid cystoscopy with sounds mimicking the prostatic urethral lift. The primary end point was comparison of AUASI reduction at 3 months. The prostatic urethral lift arm subjects were followed to 1 year and assessed for lower urinary tract symptoms, peak urinary flow rate, quality of life and sexual function. RESULTS: A total of 206 men were randomized (prostatic urethral lift 140 vs sham 66). The prostatic urethral lift and sham AUASI was reduced by 11.1±7.67 and 5.9±7.66, respectively (p=0.003), thus meeting the primary end point. Prostatic urethral lift subjects experienced AUASI reduction from 22.1 baseline to 18.0, 11.0 and 11.1 at 2 weeks, 3 months and 12 months, respectively, p<0.001. Peak urinary flow rate increased 4.4 ml per second at 3 months and was sustained at 4.0 ml per second at 12 months, p<0.001. Adverse events were typically mild and transient. There was no occurrence of de novo ejaculatory or erectile dysfunction. CONCLUSIONS: The prostatic urethral lift, reliably performed with the patient under local anesthesia, provides rapid and sustained improvement in symptoms and flow, while preserving sexual function.
RCT Entities:
PURPOSE: We report the first multicenter randomized blinded trial of the prostatic urethral lift for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. MATERIALS AND METHODS:Men at least 50 years old with AUASI (American Urological Association Symptom Index) 13 or greater, a maximum flow rate 12 ml per second or less and a prostate 30 to 80 cc were randomized 2:1 between prostatic urethral lift and sham. In the prostatic urethral lift group small permanent implants are placed within the prostate to retract encroaching lobes and open the prostatic urethra. Sham entailed rigid cystoscopy with sounds mimicking the prostatic urethral lift. The primary end point was comparison of AUASI reduction at 3 months. The prostatic urethral lift arm subjects were followed to 1 year and assessed for lower urinary tract symptoms, peak urinary flow rate, quality of life and sexual function. RESULTS: A total of 206 men were randomized (prostatic urethral lift 140 vs sham 66). The prostatic urethral lift and sham AUASI was reduced by 11.1±7.67 and 5.9±7.66, respectively (p=0.003), thus meeting the primary end point. Prostatic urethral lift subjects experienced AUASI reduction from 22.1 baseline to 18.0, 11.0 and 11.1 at 2 weeks, 3 months and 12 months, respectively, p<0.001. Peak urinary flow rate increased 4.4 ml per second at 3 months and was sustained at 4.0 ml per second at 12 months, p<0.001. Adverse events were typically mild and transient. There was no occurrence of de novo ejaculatory or erectile dysfunction. CONCLUSIONS: The prostatic urethral lift, reliably performed with the patient under local anesthesia, provides rapid and sustained improvement in symptoms and flow, while preserving sexual function.