Presentation Authors: Steven Gange*, Salt Lake City, UT, Ansar Khan, Fremont, NE, Gregg Eure, Virginia Beach, VA, Peter Walter, Cheektowaga, NY, Charles Chabert, Benowa , Australia, Paul Cozzi, Hurstville, Australia, Doug Grier, Edmonds, WA, Manish Patel, Elgin, SC, Sheldon Freedman, Las Vegas, NV, Peter Chin, Wollongong, Australia, Steven Ochs, Canton, OH, Andrew Hirsh, Somers, NJ, Michael Trotter, Austin, TX, Thomas Mueller, Voorhees, NJ
Introduction: 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 1423 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 â‰¥ 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.