Open Access

ARTICLE

Three year results of the prostatic urethral L.I.F.T. study

Claus G. Roehrborn¹, Daniel B. Rukstalis², Jack Barkin³, Steven N. Gange⁴, Neal D. Shore⁵, Jonathan L. Giddens⁶, Damien M. Bolton⁷, Barrett E. Cowan⁸, Anthony L. Cantwell⁹, Kevin T. McVary¹⁰, Alexis E. Te¹¹, Shahram S. Gholami¹², William G. Moseley¹³, Peter T. Chin¹⁴, William T. Dowling¹⁵, Sheldon J. Freedman¹⁶, Peter F. Incze¹⁷, K. Scott Coffield¹⁸, Fernando D. Borges¹⁹, Prem Rashid²⁰

1 University of Texas Southwestern Medical Center, Dallas, Texas, USA
2 Wake Forest Baptist Health, Winston-Salem, North Carolina, USA
3 Toronto Urology Clinical Study Group, Toronto, Ontario, Canada
4 Western Urological Clinic, Salt Lake City, Utah, USA
5 Carolina Urologic Research Center, Myrtle Beach, South Carolina, USA
6 Jonathan Giddens Medicine Professional Corporation, Brampton, Ontario, Canada
7 Austin Health, Heidelberg, Victoria, Australia
8 Urology Associates of Denver, Englewood, Colorado, USA
9 Advanced Urology Institute, Daytona Beach, Florida, USA
10 Southern Illinois University School of Medicine, Springfield, Illinois, USA
11 Weill Cornell Medical Center, New York, New York, USA
12 Urology Associates of Silicon Valley, San Jose, California, USA
13 Genesis Research LLC, San Diego, California, USA
14 Illawarra Urology, Figtree, NSW, Australia
15 Chesapeake Urology Research Associates, Baltimore, Maryland, USA
16 Sheldon J. Freedman, M.D., Ltd., Las Vegas, Nevada, USA
17 The Fe/Male Health Centres, Oakville, Ontario, Canada
18 Scott and White Healthcare, Temple, Texas, USA
19 Pinellas Urology Inc., St. Petersburg, Florida, USA
20 Urology Centre, Port Macquarie, Australia Address correspondence to Dr. Claus Roehrborn, Department of Urology, UT Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390 USA

Canadian Journal of Urology 2015, 22(3), 7772-7782.

Abstract

Introduction: To report the three year results of a multi-center, randomized, patient and outcome assessor blinded trial of the Prostatic Urethral Lift (PUL) in men with bothersome lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
Materials and methods: At 19 centers in North America and Australia, 206 subjects ≥50 years old with International Prostate Symptom Score (IPSS) ≥13, peak flow rate (Qmax) ≤12 mL/s, and prostate volume between 30cc-80cc were randomized 2:1 to the PUL procedure or sham control. PUL involved placing permanent UroLift implants into the lateral lobes of the prostate to enlarge the urethral lumen. After randomized comparison at 3 months, PUL patients were followed to 3 years. LUTS severity (IPSS), quality of life, Qmax, sexual function, and adverse events were assessed throughout follow up.
Results: The therapeutic effect of PUL regarding IPSS was 88% greater than sham at 3 months. Average improvements from baseline through 3 years were significant for total IPSS (41.1%), quality of life (48.8%), Qmax (53.1%), and individual IPSS symptoms. Symptomatic improvement was independent of prostate size. There were no de novo, sustained ejaculatory or erectile dysfunction events and all sexual function assessments showed average stability or improvement after PUL. Fifteen of the 140 patients originally randomized to PUL required surgical reintervention for treatment failure within the first 3 years.
Conclusions: PUL offers rapid improvement in voiding and storage symptoms, quality of life and flow rate that is durable to 3 years. Patients demonstrated a level of symptom relief that is associated with significant patient satisfaction. PUL, a minimally invasive procedure, is very effective in treating bothersome LUTS secondary to benign prostatic obstruction (BPO) and is unique in its ability to preserve total sexual function while offering a rapid return to normal physical activities.

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