MP71-08 TWO YEAR DURABILITY OF THE PROSTATIC URETHRAL LIFT: MULTI-CENTER PROSPECTIVE STUDY

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology II1 Apr 2014MP71-08 TWO YEAR DURABILITY OF THE PROSTATIC URETHRAL LIFT: MULTI-CENTER PROSPECTIVE STUDY Claus G. Roehrborn, Daniel B. Rukstalis, Jonathan L. Giddens, Steven N. Gange, Neal D. Shore, Damien M. Bolton, Barrett E. Cowan, B. Thomas Brown, Kevin T. McVary, Alexis E. Te, Shahram S. Gholami, Prem Rashid, William G. Moseley, William T. Dowling, Sheldon J. Freedman, Peter F. Incze, K Scott Coffield, Fernando D. Borgess, and Peter T. Chin Claus G. RoehrbornClaus G. Roehrborn More articles by this author , Daniel B. RukstalisDaniel B. Rukstalis More articles by this author , Jonathan L. GiddensJonathan L. Giddens More articles by this author , Steven N. GangeSteven N. Gange More articles by this author , Neal D. ShoreNeal D. Shore More articles by this author , Damien M. BoltonDamien M. Bolton More articles by this author , Barrett E. CowanBarrett E. Cowan More articles by this author , B. Thomas BrownB. Thomas Brown More articles by this author , Kevin T. McVaryKevin T. McVary More articles by this author , Alexis E. TeAlexis E. Te More articles by this author , Shahram S. GholamiShahram S. Gholami More articles by this author , Prem RashidPrem Rashid More articles by this author , William G. MoseleyWilliam G. Moseley More articles by this author , William T. DowlingWilliam T. Dowling More articles by this author , Sheldon J. FreedmanSheldon J. Freedman More articles by this author , Peter F. InczePeter F. Incze More articles by this author , K Scott CoffieldK Scott Coffield More articles by this author , Fernando D. BorgessFernando D. Borgess More articles by this author , and Peter T. ChinPeter T. Chin More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.2167AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES To report the two year results of a multi-center randomized blinded trial of the Prostatic Urethral Lift (PUL) in men with LUTS due to BPH. METHODS Men ≥ 50 years with LUTS due to BPH, an American Urological Association Symptom Index (AUASI) ≥ 13 and a peak flow (Qmax) ≤ 12 ml/s, and a prostate volume 30 to 80 cc, were randomized 2:1 between PUL and a sham procedure. After randomized comparison at 3 months, PUL patients were followed to two years. In the PUL small permanent transprostatic implants are placed to hold encroaching lobes in a retracted position and open the prostatic urethra. RESULTS 140 men were treated with PUL from February to December of 2011 in USA, Canada and Australia. In the US all but one procedure were conducted using local anesthesia. An average of 4.9 implants were used in prostates 30-77 cc. Adverse events were typically mild and transient, with most frequent being hematuria, dysuria, pelvic pain, urgency and urge incontinence. Sexual function was preserved with no incidence of de novo sustained erectile or ejaculatory dysfunction. Subjects experienced symptom relief by 2 weeks that improved to 3 months, was sustained to 12 months and modestly diminished to 24 months. Between 12 and 24 months, peak urinary flow showed improvement, and quality of life improvements were fully sustained. Between 12 and 24 months, there was 1 urinary tract infection routinely treated and no instance of urinary retention. Retreatment rates remained low with 5% by 12 months increasing to 7.1% by 24 months. Five subjects (7.4%), with an average AUASI improvement of 17.1, chose to exit the study between 12 and 24 months. CONCLUSIONS The Prostatic Urethral Lift provides a clinically meaningful improvement in LUTS and urinary flow sustained to two years. The procedure can reliably be performed under local anesthesia with low morbidity and preservation of sexual function. This study protocol will continue to evaluate PUL durability to five years. 2 Week 1 Month 3 Month 6 Month 12 Month 24 Month AUASI n (paired) 137 137 137 133 123 67 Baseline 22.1±5.4 22.1±5.4 22.1±5.4 21.9±5.4 21.8±5.4 21.5±6.0 Follow-Up 18.0±7.9 12.3±6.9 11.0±7.6 11.0±7.3 11.1±7.0 12.6±7.6 Change -4.1 -9.8 -11.1 -10.9 -10.8 -8.9 % Change (95% CI) -17% (-10%,-24%) -44% (-38%,-49%) -50% (-44%,-56%) -49% (-43%,-55%) -49% (-42%,-55%) -40% (-31%,-50%) p-value < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 QOL n (paired) 137 137 137 133 123 67 Baseline 4.6±1.1 4.6±1.1 4.6±1.1 4.6±1.1 4.5±1.0 4.5±1.0 Follow-Up 3.6±1.6 2.6±1.7 2.4±1.7 2.1±1.7 2.2±1.6 2.1±1.5 Change -1.0 -2.0 -2.2 -2.5 -2.3 -2.4 % Change (95% CI) -17% (-9%,-26%) -42% (-35%,-49%) -47% (-39%,-54%) -52% (-45%,-59%) -51% (-45%,-58%) -51% (-41%,-61%) p-value < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 BPH II n (paired) 137 137 137 133 123 67 Baseline 6.8±2.8 6.8±2.8 6.8±2.8 6.8±2.8 6.6±2.8 6.3±3.0 Follow-Up 7.0±3.4 4.0±3.1 2.9±3.0 2.6±2.8 2.7±2.9 2.4±2.8 Change 0.2 -2.8 -3.9 -4.2 -4.0 -3.9 % Change (95% CI) 31% (7%, 54%) -33% (-18%,-47%) -56% (-47%,-65%) -60% (-52%,-68%) -59% (-49%,-68%) -58% (-44%,-72%) p-value < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 < 0.0001 Qmax (mL/sec) n (paired) 124 103 55 Baseline 8.1±2.4 8.1±2.4 8.5±2.4 Follow-Up 12.4±5.4 12.1±5.4 14.1±6.5 Change 4.4 4.0 5.6 % Change (95% CI) 64% (48%,80%) 59% (41%,77%) 78% (42%,114%) p-value < 0.0001 < 0.0001 < 0.0001 © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e792-e793 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Claus G. Roehrborn More articles by this author Daniel B. Rukstalis More articles by this author Jonathan L. Giddens More articles by this author Steven N. Gange More articles by this author Neal D. Shore More articles by this author Damien M. Bolton More articles by this author Barrett E. Cowan More articles by this author B. Thomas Brown More articles by this author Kevin T. McVary More articles by this author Alexis E. Te More articles by this author Shahram S. Gholami More articles by this author Prem Rashid More articles by this author William G. Moseley More articles by this author William T. Dowling More articles by this author Sheldon J. Freedman More articles by this author Peter F. Incze More articles by this author K Scott Coffield More articles by this author Fernando D. Borgess More articles by this author Peter T. Chin More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...