Open Access

ARTICLE

Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study

Claus G. Roehrborn¹, Jack Barkin², Steven N. Gange³, Neal D. Shore⁴, Jonathan L. Giddens⁵, Damien M. Bolton⁶, Barrett E. Cowan⁷, Anthony L. Cantwell⁸, Kevin T. McVary⁹, Alexis E. Te¹⁰, Shahram S. Gholami¹¹, William G. Moseley¹², Peter T. Chin¹³, William T. Dowling¹⁴, Sheldon J. Freedman¹⁵, Peter F. Incze¹⁶, K. Scott Coffeld¹⁷, Sean Herron¹⁸, Prem Rashid¹⁹, Daniel B. Rukstalis²⁰

1 University of Texas Southwestern Medical Center, Dallas, Texas, USA
2 Toronto Urology Clinical Study Group, Toronto, Ontario, Canada
3 Summit Urology Group, Salt Lake City, Utah, USA
4 Carolina Urologic Research Center, Myrtle Beach, South Carolina, USA
5 Jonathan Giddens Medicine Professional Corporation, Brampton, Ontario, Canada
6 Austin Health, Heidelberg, Victoria, Australia
7 Urology Associates of Denver, Englewood, Colorado, USA
8 Advanced Urology Institute, Daytona Beach, Florida, USA
9 Southern Illinois University School of Medicine, Springfeld, Illinois, USA
10 Weill Cornell Medical College, New York, New York, USA
11 Urology Associates of Silicon Valley, San Jose, California, USA
12 Premier Urology Associates, San Diego, California, USA
13 Illawarra Urology, Figtree, New South Wales, Australia
14Chesapeake Urology Research Associates, Baltimore, Maryland, USA
15 Sheldon J. Freedman, M.D., Ltd., Las Vegas, Nevada, USA
16The Fe/Male Health Centres, Oakville, Ontario, Canada
17 Scott and White Healthcare, Temple, Texas, USA
18 Pinellas Urology Inc., St Petersburg, Florida, USA
19 Urology Centre, Port Macquarie, Australia
20 Wake Forest Baptist Health, Winston Salem, North Carolina, USA
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 2017, 24(3), 8802-8813.

Abstract

Introduction: To report the five year results of a prospective, multi-center, randomized, blinded sham control 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) >12, peak flow rate (Qmax) ≤12 mL/s, and prostate volume 30cc-80cc were randomized 2:1 to the PUL procedure or blinded sham control. In PUL permanent UroLift implants are placed to hold open the lateral lobes of the prostate to reduce urinary obstruction. After randomized comparison at 3 months and the only opportunity to add more PUL implants, PUL patients were followed to 5 years. LUTS severity (IPSS), quality of life (QOL), BPH Impact Index (BPHII), Qmax, sexual function, and adverse events were assessed throughout follow up.
Results: IPSS improvement after PUL was 88% greater than that of sham at 3 months. LUTS and QOL were significantly improved by 2 weeks with return to preoperative physical activity within 8.6 days. Improvement in IPSS, QOL, BPHII, and Qmax were durable through 5 years with improvements of 36%, 50%, 52%, and 44% respectively. No difference was seen between Intent to Treat and Per Protocol populations. Surgical retreatment was 13.6% over 5 years. Adverse events were mild to moderate and transient. Sexual function was stable over 5 years with no de novo, sustained erectile or ejaculatory dysfunction.
Conclusions: PUL offers rapid improvement in symptoms, QOL and flow rate that is durable to 5 years. These improvements were achieved with minimal use of a postoperative urinary catheter, rapid return to normal, and preservation of both erectile and ejaculatory function. Symptom improvement was commensurate with patient satisfaction. PUL offers a minimally invasive option in the treatment of LUTS due to BPH.

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