P2-13 PRELIMINARY RCT ANALYSIS OF MINIMALLY INVASIVE SURGERY VS. MEDICATION IN THE INITIAL TREATMENT OF BPH-ASSOCIATED LUTS

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You have accessJournal of UrologyParadigm-shifting, Practice-changing Clinical Trials in Urology (P2)1 May 2024P2-13 PRELIMINARY RCT ANALYSIS OF MINIMALLY INVASIVE SURGERY VS. MEDICATION IN THE INITIAL TREATMENT OF BPH-ASSOCIATED LUTS Philip Brodak, Shadi Tarazi, Prithipal Sethi, Michael Trotter, Dean Elterman, Sheldon Freedman, Sean Heron, Nilay Gandhi, Todd Bertoch, Gregg Eure, Wiliam Brad Roth, Thomas Mueller, Brian Mazzarella, and Claus Roehrborn Philip BrodakPhilip Brodak , Shadi TaraziShadi Tarazi , Prithipal SethiPrithipal Sethi , Michael TrotterMichael Trotter , Dean EltermanDean Elterman , Sheldon FreedmanSheldon Freedman , Sean HeronSean Heron , Nilay GandhiNilay Gandhi , Todd BertochTodd Bertoch , Gregg EureGregg Eure , Wiliam Brad RothWiliam Brad Roth , Thomas MuellerThomas Mueller , Brian MazzarellaBrian Mazzarella , and Claus RoehrbornClaus Roehrborn View All Author Informationhttps://doi.org/10.1097/01.JU.0001015816.87470.c9.13AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Benign prostatic hyperplasia (BPH) and associated lower urinary tract symptoms (LUTS) are initially treated with medical therapy or watchful waiting; medical therapy non-adherence is high due to low efficacy, sexual dysfunction, and undesirable adverse events. The Prostatic Urethral Lift (PUL) and other minimal invasive surgical therapies (MISTs) offer durable relief from symptoms, superior early patient experience and a favorable safety profile compared to TURP while preserved bladder health compared to alpha therapy alone or watchful waiting. The IMPACT RCT compares PUL using the UroLift System to medical therapy, with a focus on patient experience and efficacy through 3 months. METHODS: IMPACT is a prospective, multi-center, two-arm, 1:1 non-blinded RCT in BPH patients treated with PUL or medication (tamsulosin 0.4 mg daily) comparing safety, efficacy, and post-procedural patient experience. BPH symptom change at 3 months served as the primary endpoint, with quality-of-life, treatment goal achievement, satisfaction, sexual function, adverse events, and medication adherence as additional endpoints. This preliminary analysis reports key data gathered to date. RESULTS: 88 PUL and 112 medication subjects were available for preliminary analysis. Baseline demographics were similar between treatment groups. PUL subjects demonstrated more IPSS improvements of 39.1% and 46.8% at 1 and 3 months, respectively, compared to 16.9% and 14.2% for medication. QoL at 1 and 3 months for PUL patients improved 39.3% and 47.9%, compared to 10.2% and 7.8% for medication subjects (Table 1). Sexual function improvements (ejaculatory/erectile function, bother) were greater for PUL compared to medication subjects. PUL patients reported a more positive treatment perception at 1 and 3 months compared to medication. Baseline treatment goals were similar for PUL and medication subjects; overall goal achievement and highly rated goals (Table 1) were higher for PUL than medication at 1 and 3 months. CONCLUSIONS: IMPACT is the first head-to-head RCT comparing any MIST to medication in the treatment of LUTS secondary to BPH. Preliminary data suggests PUL offers greater improvements in quality-of-life, symptoms and patient satisfaction. Source of Funding: Teleflex, Inc © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5S2May 2024Page: e9 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Philip Brodak More articles by this author Shadi Tarazi More articles by this author Prithipal Sethi More articles by this author Michael Trotter More articles by this author Dean Elterman More articles by this author Sheldon Freedman More articles by this author Sean Heron More articles by this author Nilay Gandhi More articles by this author Todd Bertoch More articles by this author Gregg Eure More articles by this author Wiliam Brad Roth More articles by this author Thomas Mueller More articles by this author Brian Mazzarella More articles by this author Claus Roehrborn More articles by this author Expand All Advertisement PDF downloadLoading ...

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