PD21-02 PROSPECTIVE, RANDOMIZED, BLINDED STUDY OF PROSTATIC URETHRAL LIFT (PUL): FOUR YEAR RESULTS

Abstract

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology I1 Apr 2016PD21-02 PROSPECTIVE, RANDOMIZED, BLINDED STUDY OF PROSTATIC URETHRAL LIFT (PUL): FOUR YEAR RESULTS 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 Moseley, 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 MoseleyWilliam Moseley 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.2016.02.1469AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The Prostatic Urethral Lift (PUL) procedure offers rapid, durable improvement in lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia with minimal adverse effects. PUL was assessed through a large, multi-center, randomized, blinded trial with 4 year follow up. METHODS 206 men with symptomatic LUTS secondary to benign prostatic hyperplasia (BPH) were randomized to PUL (N=140) or sham control (N=66) at 19 centers in North America and Australia. Enrollment criteria included age = 50 years, IPSS (International Prostate Symptom Score) = 13, peak flow (Qmax) = 12 ml/s, and prostate volume 30 - 80 cc. With endoscopic guidance, small, permanent metallic implants were transurethrally placed into the lateral lobes of the prostate. The lobes were held in a retracted, open position which reduced urinary obstruction. Through 3 month post index procedure, patients and assessors were kept blinded to treatment arm. PUL participants were assessed through 4 years via IPSS, quality of life (QOL), BPH Impact Index (BPH II), Qmax, Sexual Health Inventory for Men (SHIM), and Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD). RESULTS Average IPSS reduction was 44% by 1 month and 46% at 4 years (p value < 0.0001). Adverse events such as hematuria, dysuria, pelvic pain, urgency, and urge incontinence were typically mild and transient. There were no reported de novo, sustained erectile or ejaculatory adverse events. Sexual function assessments (SHIM, MSHQ-EjD) show stable erectile function average score and statistically improved average ejaculatory scores. For those subjects who have reached their 4 year follow up, 19 subjects have undergone repeat PUL or other procedure. CONCLUSIONS PUL patients suffer from little morbidity and on average achieve rapid, clinically meaningful LUTS relief. This preliminary data from the largest and longest study of the PUL procedure demonstrates that relief can be sustained to 4 years. In addition, sexual function is preserved, both in terms of erection and ejaculation. Durability will be assessed through protocol driven follow up through 5 years. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e456-e457 Advertisement Copyright & Permissions© 2016MetricsAuthor 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 Moseley 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 ...