PD27-01 5 YEAR PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY RESULTS ON THE MINIMALLY INVASIVE PROSTATIC URETHRAL LIFT (PUL)

Abstract

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology IV1 Apr 2017PD27-01 5 YEAR PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY RESULTS ON THE MINIMALLY INVASIVE PROSTATIC URETHRAL LIFT (PUL) Claus Roehrborn, Steven Gange, Neal Shore, Jonathan Giddens, Damien Bolton, Barrett Cowan, Anthony Cantwell, Kevin McVary, Peter Chin, Alexis Te, Shahram Gholami, Prem Rashid, William Moselely, Ronald Tutrone, Sheldon Freedman, Peter Incze, K. Scott Coffield, Fernando Borges, and Daniel Rukstalis Claus RoehrbornClaus Roehrborn More articles by this author , Steven GangeSteven Gange More articles by this author , Neal ShoreNeal Shore More articles by this author , Jonathan GiddensJonathan Giddens More articles by this author , Damien BoltonDamien Bolton More articles by this author , Barrett CowanBarrett Cowan More articles by this author , Anthony CantwellAnthony Cantwell More articles by this author , Kevin McVaryKevin McVary More articles by this author , Peter ChinPeter Chin More articles by this author , Alexis TeAlexis Te More articles by this author , Shahram GholamiShahram Gholami More articles by this author , Prem RashidPrem Rashid More articles by this author , William MoselelyWilliam Moselely More articles by this author , Ronald TutroneRonald Tutrone More articles by this author , Sheldon FreedmanSheldon Freedman More articles by this author , Peter InczePeter Incze More articles by this author , K. Scott CoffieldK. Scott Coffield More articles by this author , Fernando BorgesFernando Borges More articles by this author , and Daniel RukstalisDaniel Rukstalis More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.1222AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The Prostatic Urethral Lift (PUL) has been previously shown to rapidly and durably address lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia with minimal side effects. The 5 year concluding data from the largest multi-center, randomized, controlled, study on PUL is herein presented. METHODS PUL procedure involves placing permanent UroLift® implants into the lateral lobes of the prostate to enlarge the urethral lumen. Enrollment criteria included age = 50 years, IPSS (International Prostate Symptom Score) = 13, peak flow rate = 12 ml/s, and prostate volume 30 - 80 cc. At 19 centers in North America and Australia, 206 men with symptomatic LUTS were randomized to PUL (N = 140) or sham control (N = 66). Patients and assessors were kept blinded to treatment arm for 3 months. Assessments for PUL subjects continued through 5 years. RESULTS PUL patients experienced symptom relief by 1 month (IPSS: 44% and QoL: 42%, p < 0.001) and remained improved through 5 years (IPSS: 38% and QoL: 54%, p < 0.001). Peak urinary flow rate remained improved 41% at 5 years. Sexual function was preserved in the PUL cohort, as assessments show stable erectile function average score and improved ejaculatory function and ejaculatory bother average scores (p<0.001). Further, no patient was found to experience de novo, sustained erectile or ejaculatory dysfunction. Adverse events were typically mild and transient. CONCLUSIONS The final long term data from the largest study on the PUL procedure demonstrates that this minimally invasive approach improves symptoms durably. Quality of life, BPH impact index and peak flow rate improvements are also sustained. As assessed by questionnaires and adverse event reporting, erectile and ejaculatory function are preserved. The final 5 year analysis indicates stable symptom relief and facilitates the understanding of the long term effects of the PUL procedure. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e511 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Claus Roehrborn More articles by this author Steven Gange More articles by this author Neal Shore More articles by this author Jonathan Giddens More articles by this author Damien Bolton More articles by this author Barrett Cowan More articles by this author Anthony Cantwell More articles by this author Kevin McVary More articles by this author Peter Chin More articles by this author Alexis Te More articles by this author Shahram Gholami More articles by this author Prem Rashid More articles by this author William Moselely More articles by this author Ronald Tutrone More articles by this author Sheldon Freedman More articles by this author Peter Incze More articles by this author K. Scott Coffield More articles by this author Fernando Borges More articles by this author Daniel Rukstalis More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...