(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

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