(488) Pooled Outcomes from over 300 Controlled Subjects Reveal Improvements in Sexual Function and a Majority Shift to Lower IPSS Symptom Severity after Treatment with PUL

Abstract Introduction The Prostatic Urethral Lift (PUL) is the most thoroughly studied minimally invasive surgical therapy (MIST) for BPH with over 300 patients in a controlled trial setting. Objective In this combined analysis from 5 PUL studies we examine meta-effect of procedure on outcomes including sexual function and proportion subjects who move higher to lower IPSS symptom severity grades. Methods Five were utilized analysis, L.I.F.T. (RCT: vs Sham [n = 140]), Crossover (crossover sham 51]), MedLift (single arm, OML 45]), BPH6 (RCT; TURP [n=44]), LOCAL (Single under local anesthesia office [n=51]]. Sexual was evaluated SHIM MSHQ-EjD, as well IPSS, QoL, Qmax at baseline through 12M post-PUL. Post-op AEs, catheterization, retreatment, medication usage, level shift, responder rate (≥3pt improvement baseline) examined 12M. Results 331 treated among five had largely similar characteristics. 266 sexually active baseline, notable improvements found (13%, p<0.01) MSHQ-EjD (30%, 12mo. Post-PUL, mean improved 1, 3, 6, least 11.1 points (48.5%, p <0.0001). QoL up 52.8% (p <0.0001) increased by 4.3 ml/sec Most AEs mild moderate resolved within 2 weeks. 33% (73/121) void trial-tested required catheterization (mean duration 3.7d). 15 underwent retreatment 7 needed 79% (261/331) responders 66% (219/331) moved into grade (Table 1). Subjects shift average (1.8 3.1, p<0.000), (13.3 11.9, p<0.05) more implants (median 4 implants, p<0.01). Conclusions largest men demonstrates provides significant experienced 12 months. Disclosure Yes, sponsored industry/sponsor: Neotract, Inc./Teleflex. Clarification Industry initiated, executed funded study. Any authors act consultant, employee or shareholder an industry for: