4th Annual Jefferson Urology Symposium: Focus on Urinary Incontinence

© The Canadian Journal of Urology TM : International Supplement, August 2021 Leong ET AL. the L.I.F.T. study by Roehrborn et al. This study demonstrated rapid and significant improvement of urinary symptoms that were durable up to 5 years. Specifically, when compared to baseline, patient’s AUASI improved by 7.6 points (36%), QoL improved by 2.3 points (50%), BPHII improved by 3.5 points (52%) and Qmax improved by 3.5 mL/sec (44%) at 5 years. Sexual function was excellently preserved as shown by the objectively measured SHIM, MSHQ- EjD function and MSHQ-EjD bother score, with no reports of de novo, sustained ejaculatory or erectile dysfunction. The authors also report a surgical retreatment rate of 13.6% over 5 years with a return to preoperative physical activity period of 8.6 days. 12 Aprospective, randomized controlled trial, known as the BPH6 study, was also performed among a multicentered European cohort and compared the PULwith the TURP procedure. In this study, patients who underwent the UroLift procedure showed a more rapid recovery period when compared to patients who underwent a TURP. Moreover, preservation of ejaculatory function, due to the lack of effect on the apical tissuearound theverumontanumand thebladder neck, and speed of recovery was superior for PUL. 13,14 Yet another multicentered review reported substantial symptomatic relief with significant improvements in IPSS, QoL, Qmax and PVR parameters within 1 month of the PULprocedure. Sexual functionwas unchanged and side effects were minimal and transient. They report a 12.8% retreatment rate over 2 years and 86% catheter-free rate for patients who had an indwelling catheter before the procedure. 15 Similar to the efforts of comparing the post- procedural sexual function between the Rezumpivotal study and patients from theMTOPS trial, Roehrborn et al performed an analysis with patients who underwent PUL from the L.I.F.T. study. 16 Indirect comparison found that PULwas superior to medical management for BPH in preserving both sexual function (erectile and ejaculatory) and sexual satisfaction. Limitations to the study include the use of two different patient- reported questionnaires, namely the IIEF or MSHQ for the L.I.F.T. study and the BMSFI for the MTOPS trial. Next, contemporary research on PUL is based on enlarged lateral lobes alone. However, a recent study in 2018 known as theMedLift study sought to examine the utility and safety of the UroLift in the setting of obstructing median lobes. With appropriately deployed implants, a portion of the median lobe can be distracted distal to the bladder neck and affixed laterally to the prostatic urethra. This opens a channel around the median lobe and reduces the “ball-valve” motion caused by the enlarged median lobe. This study was performed as a single-arm, prospective trial with a mean number of 1.3 implants deployed into the median lobe. Importantly, primary effectiveness and safety endpoints weremet, with the patients among the MedLift arm demonstrating 57.7% IPSS improvement at 6 months. An effort was made to compare and combine the results from theMedLift trial to the L.I.F.T. study to demonstrate the full effect of the PUL and similar improvements of LUTS were found. 17 The PULSAR (Prostatic Urethral Lift Subject with Acute Urinary Retention) clinical trial (NCT03194737) is currently underway to assess the utility of UroLift in patients presenting with acute urinary retention. They included patients in retention who has failed at least one void trial while on an α-blocker. Primary assessment for this study was a void trial at 3 days ± 1 day post procedure. Preliminary results suggest that the improvement of LUTS is objectively better than that of the L.I.F.T. cohort at 6 and 12 months. With regards to patient experience, 67% of patients who stopped taking their α-blockers remained medication free on follow up and 87.5% of patients reported an average of 8.5 days for a “return to normal” time period. A retrospective review by Eure et al aimed to evaluate the safety and efficacy of PUL in the real world setting and determine if outcomes would hold up to those from controlled clinical studies. Overall, these men were found to be older and less symptomatic, and the authors found that PUL did in fact perform well in the real-world setting with regards to symptom relief, patient experience and overall morbidity. Only 72 patients (5.1%) of patients underwent surgical retreatment, 39 (2.8%) of which underwent a repeat PUL procedure. When stratifying based on prostate volume, there were no significant difference in symptomatic improvement, adverse event rates and catheter-free rates of prostates measuring > 80 cc when compared to smaller prostates. 18 With regards to safety of this procedure, an analysis of device malfunctions and complications related to BPH surgery using the MAUDE database revealed a total of 16 incidents with the UroLift device. Of these, 10 were due to failure to deploy implant, while the other 6 were due to needle detachment. When compared to the other treatment modalities including TURP, HoLEP, GreenLight, the 16 UroLift cases accounted for only 0.6% of all malfunctions reported in this database. 19 Lastly, a small study published in 2020 aimed to evaluate the early postoperative patient experience between Urolift and Rezum over 2 months post- procedure. Although the preliminary data suggest better improved overall experiences for patients 4