Abstracts from the Abstracts from the Mid-Atlantic Section of the AUA 2021

MA-AUA 2021 Abstracts Moderated Poster Session 3: BPH/Urodynamics MP3-04 Sizeable data for Prostatic Urethral Lift (PUL) in retention patients: 12 month outcomes from the large real-world study and urodynamic results from PULSAR demonstrate PUL is safe and effective G. Eure 1 , M. Rochester 2 , N. Barber 3 , O. Kayes 4 , N. Thiruchelvam 5 , K. Rajesh 6 , T. Page 7 , D. Grier 8 1 Urology of Virginia, Virginia Beach, VA, USA; 2 Norfolk and Norwich University Hospital, Norwich, United Kingdom; 3 Frimley Park Hospital, Frimley, United Kingdom; 4 St. James University Hospital, Leeds, United Kingdom; 5 Addenbrooke’s Hospital, Cambridge, United Kingdom; 6 Central Middlesex Hospital, London, United Kingdom; 7 Freeman Hospital, Tyne and Wear, United Kingdom; 8 Sound Urological Associates, Edmonds, WA, USA Introduction and Objective: Minimally invasive surgical therapies for BPH should be tested in real-world and controlled trial settings in various patient populations, including those in urinary retention. Here, we report outcomes of PUL in real-world retention patients real-world and in the controlled PULSAR study with newly analyzed urodynamics data. Methods: The controlled PULSAR study followed 52 retention subjects with ≥1 failed TWOC on alpha blocker through12 months after PUL. Outcomes included SHIM, satisfaction, and urodynamics. The Real-World Retrospective (RWR) database included 512 subjects in active urinary retention status at the time of PUL. RWR retention (RWR-r) and PULSAR subjects were compared in baseline characteristics, absolute IPSS, QoL, Qmax, PVR, and AE and catheter-independence rates. Results: Baseline characteristics were similar between RWR-r and PULSAR subjects (age: 71yo for both groups, prostate size: 48cc vs. 55cc, number of implants/patient: 4.7 vs. 4.8). 90% of PULSAR subjects felt better after PUL and 88%would recommend the procedure. Erectile function (via SHIM) was preserved in PULSAR subjects. Of 12 PULSAR subjects with urodynamics data, pdet@Qmax and BOOI improved by 23% and 41% (Fig 1). 86% of those who remained obstructedwere catheter-independent and 83% felt verymuch better. Absolute IPSS, Qmax, and PVR were equivalent between RWR-r and PULSAR subjects at 12 months, but PULSAR QoL was better (1.4 vs. 2.1). RWR-r catheter-independence rates were better at 1 month post-PUL (81% vs. 60%) and longest available follow-up (84% vs. 73%). AEs overall were not elevated in RWR-r subjects compared to PULSAR. Conclusions: This large RWR and the controlled PULSAR study reveal stable and largely consistent outcomes in retention patients at 12 months, indicating that PUL is safe and effective in this population of BPH patients. Outcomes of Prostatic Urethral Lift (PUL) are Consistent Across Heterogenous Patient Populations in the Real World T. Mueller 1 , E. Mobley 2 , M. Trotter 3 , M. Rochester 4 , N. Barber 5 , G. Eure 6 , D. Grier 7 1 Delaware Valley Urology, Voorhees, NJ, USA; 2 Urology Austin, Round Rock, TX, USA; 3 Midtown Urology Associates, Austin, TX, USA; 4 Norfolk and Norwich University Hospital, Norwich, United Kingdom; 5 Frimley Park Hospital, Frimley, United Kingdom; 6 Urology of Virginia, Virginia Beach, VA, USA; 7 Sound Urological Associates, Edmonds, WA, USA Introduction and Objective: Minimally invasive surgical therapy (MIST) for BPH should provide effective symptom relief with minimal morbidity as demonstrated in the real-world and in controlled studies. Here, we expand results from the large real-world retrospective (RWR) study of the minimally invasive PUL and compare to controlled studies. Methods: The international RWR database includes 3226 PUL subjects (non- retention at baseline, n=2714; retention, n=512). Non-retention subjects were stratified by baseline symptoms (matching LIFT enrollment criteria (n=1117)), clinic office setting (n=883), prostate volume (≥80g, n=85), OML (n=277), prior radiation therapy for prostate cancer (rCaP) (n=82), and Parkinson’s Disease (PD, n=16). Outcomes were compared to controlled trials for PUL: LIFT for non-retention, and the PULSAR controlled trial of 52 retention subjects. Results: RWR subjects were on average 70yo with baseline IPSS, QoL, and Qmax of 19.2, 3.9, and 11.7 ml/s, respectively. Subjects who matched LIFT baseline criteria improved similarly to LIFT at 12 and 24 months. Outcomes of retention subjects were consistent with PULSAR. Subjects treated in the clinic office with local anesthesia significantly improved with lower rates of total AEs. Symptom response was equivalent between subjects with prostates ≥80g and <80g. OML subjects improved similarly to non-OML subjects, without increased rates ofAEs. rCaP subjects improved frombaselinewithout elevated levels of PSA. Absolute symptom response of PD subjects through 12 months and total AE rates were equivalent to non-PD subjects. Absolute IPSS was equivalent between retention and non-retention subjects. Conclusions: This analysis of real-world PUL data demonstrates that symptom response and safety outcomes are largely consistent with controlled studies and across heterogenous groups, indicating that PUL is a viable treatment option for a broad variety of BPH patients in the real-world. MP3-03 19

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