MP3-02 CROSSOVER STUDY OF THE PROSTATIC URETHRAL LIFT FOR LUTS SECONDARY TO BPH: 2 YEAR RESULTS

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology I1 Apr 2015MP3-02 CROSSOVER STUDY OF THE PROSTATIC URETHRAL LIFT FOR LUTS SECONDARY TO BPH: 2 YEAR RESULTS Henry Woo, Anthony Cantwell, William Bogache, Stephen Richardson, Ronald Tutrone, Prem Rashid, Jack Barkin, James Fagelson, and Peter Chin Henry WooHenry Woo More articles by this author , Anthony CantwellAnthony Cantwell More articles by this author , William BogacheWilliam Bogache More articles by this author , Stephen RichardsonStephen Richardson More articles by this author , Ronald TutroneRonald Tutrone More articles by this author , Prem RashidPrem Rashid More articles by this author , Jack BarkinJack Barkin More articles by this author , James FagelsonJames Fagelson More articles by this author , and Peter ChinPeter Chin More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.105AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES To study the effect of the Prostatic Urethral Lift (PUL) procedure on men suffering from lower urinary tract symptoms (LUTS) through a multi-center, prospective crossover design study with 2 year follow up. METHODS This crossover study included 53 subjects who were enrolled in a prospective, randomized, controlled, blinded study at 19 centers in North America and Australia. They were randomized to receive the sham procedure which involved rigid cystoscopy with simulated active treatment sounds. Three months later they were unblinded and allowed to undergo crossover PUL which involved the placement of permanent UroLift® implants into the lateral lobes of the prostate. Assessments were made through 2 years on symptom response, quality of life, peak flow rate (Qmax), sexual function, and adverse events. The self-controlled dataset allowed for comparisons of individual responses to both procedures and two year follow up of the active treatment response. RESULTS The PUL procedure was found to relieve symptoms substantially more than the sham procedure (p<0.001). Symptoms and flow both improved after sham but showed decay over time. Both measures were significantly further improved after crossover PUL and durable through 2 years. When compared to symptoms prior to the sham procedure, AUASI (American Urological Association Symptom Index) improved 9.7 (p<0.001) and Qmax improved 4.1 ml/s (p<0.001) at 2 years. Adverse events associated with the procedure were typically transient and mild to moderate. Over the 2 year follow up, four subjects (7.7%) elected to undergo TURP due to insufficient response to PUL. There were no occurrences of de novo, sustained ejaculatory or erectile dysfunction. Further, sexual function measures in the erectile, ejaculatory, and ejaculatory bother domains improved after PUL at every time point. CONCLUSIONS The results of this crossover study with each patient serving as his own control show that the Prostatic Urethral Lift is associated with clinically and statistically significant treatment effect beyond sham therapy. Morbidity after the procedure was low. PUL can be performed under local anesthesia and allows subjects to quickly return to normal activity. PUL may be uniquely suited to treat LUTS while preserving sexual function. Table 1. Baseline, follow-up, and change in each paired outcome measure during control sham period and crossover PUL period compared to values prior to sham procedure through 2 years in the same patient cohort. Abbreviation key: QOL (AUA SI quality of life), BPHII (BPH Impact Index), SHIM (Sexual Health Inventory for Men), and MSHQ-EjD (Male Sexual Health Questionnaire for Ejaculatory Dysfunction). Control Sham Period Crossover PUL Period 3 Months 3 Months 6 Months 1 Year 2 Years AUA SI N 51 50 51 49 43 Baseline 25.4 ± 5.5 25.4 ± 5.5 25.4 ± 5.5 25.5 ± 5.6 24.9 ± 5.7 Follow-up 20.2 ± 8.4 12.3 ± 8.0 13.1 ± 7.7 15.2 ± 8.1 15.2 ± 7.1 Change -5.2 ± 7.7 -13.1 ± 7.3 -12.4 ± 7.9 -10.3 ± 7.8 -9.7 ± 8.4 QOL N 51 50 51 49 43 Baseline 4.8 ± 1.1 4.8 ± 1.1 4.8 ± 1.1 4.8 ± 1.1 4.7 ± 1.1 Follow-up 3.9 ± 1.6 2.2 ± 1.5 2.5 ± 1.4 2.7 ± 1.7 2.6 ± 1.5 Change -0.9 ± 1.4 -2.6 ± 1.6 -2.4 ± 1.6 -2.0 ± 1.8 -2.1 ± 1.8 BPH II N 51 50 51 49 43 Baseline 7.3 ± 3.1 7.3 ± 3.1 7.3 ± 3.0 7.4 ± 3.1 7.1 ± 3.0 Follow-up 5.3 ± 3.2 2.9 ± 2.9 2.8 ± 2.5 3.4 ± 2.8 3.2 ± 2.7 Change -2.0 ± 3.4 -4.4 ± 3.4 -4.5 ± 3.2 -4.0 ± 3.4 -4.0 ± 3.1 Qmax N 43 42 43 37 Baseline 8.1 ± 2.5 8.0 ± 2.5 8.1 ± 2.5 8.0 ± 2.5 Follow-up 10.0 ± 4.6 12.0 ± 5.8 12.1 ± 5.3 12.1 ± 5.7 Change 1.9 ± 5.2 4.0 ± 6.5 4.0 ± 5.6 4.1 ± 6.4 SHIM N 38 37 38 34 32 Baseline 16.0 ± 7.4 16.5 ± 7.3 16.1 ± 7.6 17.1 ± 6.8 15.8 ± 8.2 Follow-up 17.0 ± 7.2 16.5 ± 8.2 16.6 ± 7.7 17.8 ± 6.7 16.6 ± 8.7 Change 0.9 ± 4.3 0.1 ± 6.3 0.5 ± 5.7 0.7 ± 4.7 0.8 ± 6.3 MSHQ-EjD function N 39 37 38 34 32 Baseline 8.7 ± 2.9 8.9 ± 3.2 8.8 ± 3.1 8.9 ± 3.3 8.8 ± 3.2 Follow-up 10.8 ± 3.3 11.2 ± 3.4 11.1 ± 2.9 10.9 ± 2.9 10.4 ± 3.2 Change 2.1 ± 2.8 2.3 ± 3.1 2.3 ± 2.6 2.1 ± 2.9 1.6 ± 2.8 MSHQ-EjD bother N 39 36 38 34 32 Baseline 2.2 ± 1.7 2.1 ± 1.8 2.1 ± 1.7 2.1 ± 1.8 2.2 ± 1.8 Follow-up 1.4 ± 1.6 1.1 ± 1.6 1.1 ± 1.3 1.1 ± 1.4 1.3 ± 1.7 Change -0.9 ± 1.6 -1.0 ± 1.4 -1.1 ± 1.8 -1.0 ± 1.5 -1.0 ± 1.6 © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e19-e20 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Henry Woo More articles by this author Anthony Cantwell More articles by this author William Bogache More articles by this author Stephen Richardson More articles by this author Ronald Tutrone More articles by this author Prem Rashid More articles by this author Jack Barkin More articles by this author James Fagelson More articles by this author Peter Chin More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...