You have accessJournal of UrologyBenign Prostatic Hyperplasia: Medical & Non-surgical Therapy (PD24)1 Apr 2019PD24-07 REAL WORLD OUTCOMES OF PROSTATIC URETHRAL LIFT CONFIRM CLINICAL STUDY RESULTS Steven Gange*, Ansar Khan, Gregg Eure, Peter Walter, Charles Chabert, Paul Cozzi, Doug Grier, Manish Patel, Sheldon Freedman, Peter Chin, Steven Ochs, Andrew Hirsh, Michael Trotter, and Thomas Mueller Steven Gange*Steven Gange* More articles by this author , Ansar KhanAnsar Khan More articles by this author , Gregg EureGregg Eure More articles by this author , Peter WalterPeter Walter More articles by this author , Charles ChabertCharles Chabert More articles by this author , Paul CozziPaul Cozzi More articles by this author , Doug GrierDoug Grier More articles by this author , Manish PatelManish Patel More articles by this author , Sheldon FreedmanSheldon Freedman More articles by this author , Peter ChinPeter Chin More articles by this author , Steven OchsSteven Ochs More articles by this author , Andrew HirshAndrew Hirsh More articles by this author , Michael TrotterMichael Trotter More articles by this author , and Thomas MuellerThomas Mueller More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000555954.91393.d0AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: Recent clinical trials reveal significant advantages Prostatic Urethra Lift (PUL) provides patients suffering from LUTS/BPH, however few studies have evaluated outcomes in the real world. The objective of this study was to examine results of PUL within the largest unconstrained patient population. Analysis was also performed on site of service to assess procedural safety in an office setting. METHODS: Retrospective chart review of 1,423 consecutive patients who received PUL across 14 sites in North America and Australia was performed. Symptom response (IPSS), quality of life (QoL) and peak flow rate (Qmax) were assessed at 1, 3, 6, 12 and 24 months post-procedure for the following cohorts: (1) total study population; (2) subjects with baseline IPSS ≥ 13. Patient follow up was analyzed using paired t-tests and 95% mean confidence intervals. IPSS outcomes from cohort 2 were compared to L.I.F.T. results at all timepoints. Incidence of post-procedural catheterization, surgical intervention and adverse events was analyzed and summarized descriptively. RESULTS: Compared to L.I.F.T, subjects in the real-world registry were older (70 years, p<0.01), had lower baseline IPSS (19.2, p<.0001), QoL (4.0, p<.0001) and higher Qmax (12.6, p<.0001) scores. Following PUL, mean IPSS for cohort 1 improved significantly at all timepoints by at least 8.1 points (Table 1, p<.0001). QoL improved by an average of 42% and Qmax improvement ranged from 15-36% (Table 1). Cohort 2 IPSS improvement was not significantly different compared to subjects from L.I.F.T. 61 surgical retreatments (excluding subjects with baseline urinary retention, prostate cancer and prostate size >80cc) occurred. Most adverse events were mild to moderate and transient. In the USA, 449 of 1146 (39%) procedures were performed in a clinic office, and 74.2% (333/449) were conducted using only local anesthesia. No significant differences in symptom outcomes and adverse events were observed between procedures conducted in the clinic office versus other settings. CONCLUSIONS: The first ever analysis of patients who received PUL in a commercial setting demonstrates efficacy and implementation consistent with previous clinical studies. Site of service in the clinic office does not appear to change symptom response and safety. Source of Funding: Neotract/Teleflex Inc. Salt Lake City, UT; Fremont, NE; Virginia Beach, VA; Cheektowaga, NY; Benowa, Australia; Hurstville, Australia; Edmonds, WA; Elgin, SC; Las Vegas, NV; Wollongong, Australia; Canton, OH; Somers, NJ; Austin, TX; Voorhees, NJ© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e465-e465 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information Steven Gange* More articles by this author Ansar Khan More articles by this author Gregg Eure More articles by this author Peter Walter More articles by this author Charles Chabert More articles by this author Paul Cozzi More articles by this author Doug Grier More articles by this author Manish Patel More articles by this author Sheldon Freedman More articles by this author Peter Chin More articles by this author Steven Ochs More articles by this author Andrew Hirsh More articles by this author Michael Trotter More articles by this author Thomas Mueller More articles by this author Expand All Advertisement PDF downloadLoading ...

Introduction: This study expands results from recent prostatic urethral lift (PUL) clinical trials by examining outcomes within a large unconstrained multicenter data set. Methods: Retrospective chart review and analysis of 1413 consecutive patients who received PUL in North America and Australia was performed. International Prostate Symptom Score (IPSS), quality of life (QoL), and maximum urinary flow rate (Qmax) were evaluated at 1, 3, 6, 12, and 24 months post-procedure for all nonurinary retention subjects (Group A) and retention subjects (Group B). Within Group A outcomes were further analyzed using paired t-tests and 95% mean confidence intervals under the following parameters: IPSS baseline ≥13, age, prostate size, site of service, prostate cancer treatment, and diabetic status. Adverse events, surgical interventions, and catheterization rates were summarized in detail. Results: Compared with the randomized controlled prosatic urethral lift (L.I.F.T.) study, subjects in this retrospective study were older and less symptomatic. After PUL, mean IPSS for Group A improved significantly from baseline by at least 8.1 points throughout follow-up. No significant differences were observed between Group A and B follow-up symptom scores. Within Group A, subjects with an IPSS baseline ≥13 behaved similarly to L.I.F.T. subjects. Age, prostate volume, site of service, prior cancer treatment, and diabetic status did not significantly affect PUL outcomes. When completed in a clinic office, PUL resulted in less side effects and catheter placement compared to other sites of service. Previous prostate cancer treatment did not elevate adverse events of high concern such as incontinence and infection. Conclusion: PUL performs well in a real-world setting in terms of symptom relief, morbidity, and patient experience for all studied patient cohorts.