MP71-06 CROSSOVER STUDY OF THE PROSTATIC URETHRAL LIFT: ANALYSIS OF INDIVIDUAL LOWER URINARY TRACT SYMPTOMS

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology II1 Apr 2014MP71-06 CROSSOVER STUDY OF THE PROSTATIC URETHRAL LIFT: ANALYSIS OF INDIVIDUAL LOWER URINARY TRACT SYMPTOMS Henry Woo, Anthony Cantwell, William Bogache, Stephen Richardson, Ronald Tutrone, 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 , 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.2014.02.2165AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES To analyze the effect of the Prostatic Urethral Lift (PUL) on lower urinary tract symptoms (LUTS) through a multi-center, prospective crossover design study. METHODS This study included 53 subjects who underwent a sham procedure through a prospective, randomized, controlled, blinded study at 19 centers in North America and Australia and then elected after unblinding at 3 months to undergo crossover PUL. Sham procedure involved rigid cystoscopy with simulated active treatment sounds. PUL involved placing permanent UroLift® implants into the lateral lobes of the prostate to enlarge the urethral lumen. Through 1 year follow up, assessments were made concerning symptoms, quality of life, urinary flow rate, sexual function, and adverse events. Analysis of each IPSS parameter allowed for assessment of specific symptom responses to treatment. RESULTS The effect of the PUL on LUTS was found to be substantially greater than the sham response (Table 1, p-Value < 0.001). Analysis of the individual symptoms assessed through the IPSS demonstrated durable and significant improvement from baseline in all symptom parameters from 1 through 12 months (Figure 1, all p-Values < 0.02). Qmax increased after PUL and remained improved at 2.9 ml/s at 12 months (Table 1, p-Value < 0.001). Adverse events associated with the procedure were typically transient and mild to moderate. One subject (2%) required TURP in the first year. 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 Prostatic Urethral Lift can provide rapid, durable symptom relief and flow rate improvements without exposing the patient to unsatisfactory perioperative risk. LUTS improves in both storage and voiding domains. The procedure 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 outcome measure after control sham therapy followed by crossover PUL in the same patient cohort. Each parameter is presented as mean ± standard deviation. Outcome Measure (N=paired sample size) Control Sham: Baseline Control Sham: 3 Months Control Sham: Change Crossover PUL: Baseline Crossover PUL: 3 Months Crossover PUL: Change p-Value AUASI (53) 25.2 ± 5.7 20.2 ± 8.3 -5.0 ± 7.5 23.4 ± 5.5 12.3 ± 7.9 -11.1 ± 7.2 < 0.001 QOL (52) 4.8 ± 1.1 3.9 ± 1.6 -0.8 ± 1.4 4.5 ± 1.2 2.2 ± 1.5 -2.3 ± 1.7 < 0.001 BPHII (52) 7.2 ± 3.2 5.3 ± 3.2 -1.9 ± 3.4 6.2 ± 2.9 3 ± 2.9 -3.3 ± 2.9 0.024 Qmax (39) 7.9 ± 2.4 10.3 ± 4.6 2.4 ± 5.1 9.6 ± 4.3 12.0 ± 6.1 2.4 ± 5.3 1 MSHQ-EjD Function (36) 11.3 ± 4.2 9.1 ± 3.8 -2.1 ± 4.2 8.9 ± 3.6 9.9 ± 3.7 1.0 ± 2.9 0.003 MSHQ-EjD Bother (36) 3.3 ± 1.7 2.4 ± 1.7 -0.8 ± 1.6 2.5 ± 1.7 2.1 ± 1.6 -0.4 ± 1.3 0.312 IIEF-5 (SHIM) (36) 16.2 ± 7.2 17 ± 7.2 0.8 ± 4.3 16 ± 6.7 16.3 ± 8.2 0.3 ± 4.7 0.636 p-Value obtained using a paired Student's t-test. AUASI – American Urological Association Symptom Index; QOL – AUASI Quality of Life; BPHII – BPH Impact Index; Qmax – peak urinary flow; MSHQ-EjD– Male Sexual Health Questionnaire for Ejaculatory Dysfunction; IIEF – International Index for Erectile Function. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e791-e792 Advertisement Copyright & Permissions© 2014MetricsAuthor 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 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 ...