PURPOSE:The ProVee System for benign prostatic hyperplasia is a new generation permanent prostatic urethral stent for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. ProVIDE is a prospective, randomized, double-blind, sham-controlled study evaluating the safety and effectiveness of ProVee against a sham procedure. MATERIALS AND METHODS:Men at least aged 45 years were eligible for the study if they had International Prostate Symptom Score ≥ 13, peak urinary flow rate < 12 mL/s, prostate volume 30 to 80 cc, and prostatic urethral length ≥3.75 cm. Primary effectiveness endpoints were a mean improvement in International Prostate Symptom Score at 3 months and 12 months. Symptomatic improvement, uroflowmetry, quality of life, and sexual function were assessed at follow-up. RESULTS:A total of 221 participants were randomized 2:1 (150 ProVee, 71 sham) at 15 centers in the United States and 2 centers outside the United States. Treatments were performed in an ambulatory surgery center or office setting and required no catheterization postprocedure. Intention-to-treat analyses showed a > 25% mean improvement in International Prostate Symptom Score over sham at 3 months (9.5 vs 5.6, P = .001) and a > 30% mean improvement from baseline to 12 months in the ProVee arm (37.8%, P = .002). There were no device-related or procedure-related serious adverse events through 12 months, and no incidence of de novo sustained retrograde ejaculation or erectile dysfunction. CONCLUSIONS:Treatment with ProVee was reliably performed and resulted in a statistically superior improvement in International Prostate Symptom Score at 3 months compared with a sham procedure with sustained response at 12 months. CLINICAL TRIAL REGISTRATION NUMBER:NCT05186740.

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 ...

We describe our use of balloon-expandable stents in pulmonary arteries for a variety of indications. This is an endovascular technique that provides an alternative treatment option to treat some forms of complex pulmonary artery disease when standard surgical or other endovascular options are not possible. This case series describes the successful treatment of four patients with different pulmonary artery diseases. Indications for stent placement include multiple broad-necked pulmonary artery pseudoaneurysms, symptomatic malignant pulmonary artery narrowing and post-surgical iatrogenic pulmonary artery stenosis. No stent-related complication had been identified from 3 months to 4 years of follow-up. All surviving patients have experienced sustained symptomatic improvement.

BACKGROUND:Pulmonary arterial hypertension (PAH) is a progressively fatal disease. Parenteral prostanoids, including intravenous (IV) epoprostenol, are the most effective therapies for PAH. As epoprostenol requires continuous infusion, therapy is challenging and use is managed by specialist units.AIMS:To describe the clinical outcomes for the use of IV epoprostenol in an Australian pulmonary vascular disease unit and identify opportunities to improve its use.METHOD:We conducted a retrospective chart review of all adult patients who received IV epoprostenol for PAH at Prince Charles Hospital. Data were collected at baseline, initiation of epoprostenol and quarterly to the end of the audit period or the discontinuation of epoprostenol. Descriptive statistics were performed and comparisons made to epoprostenol initiation. Kaplan-Meier curves were used to estimate survival outcomes.RESULTS:Thirty-nine patients received epoprostenol therapy. Most (87.2%) were female, had connective tissue disease (46.2%) or idiopathic PAH (35.9%) and had a World Health Organization functional Class of III or IV at initiation. The mean duration of epoprostenol therapy was 2.9 years. Intravenous epoprostenol was associated with favourable outcomes; 1, 3 and 5-year survival rates since initiation of 90.0, 75.8 and 68.2%; robust improvements in functional class; and improvements in 6-min walking distance of 160.4 m at 3 years; 94.9% patients experienced at least one drug-related adverse event and line complications were common.CONCLUSION:Epoprostenol therapy was associated with impressive survival rates and durable improvements in functional outcomes. Epoprostenol therapy is challenging; however, it is manageable by the majority of patients with most experiencing positive, sustainable outcomes.

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Medical & Non-surgical Therapy (PD24)1 Apr 2019PD24-07 REAL WORLD OUTCOMES OF PROSTATIC URETHRAL LIFT CONFIRM CLINICAL STUDY RESULTS Steven Gange*, Ansar Khan, Gregg Eure, Peter Walter, Charles Chabert, Paul Cozzi, Doug Grier, Manish Patel, Sheldon Freedman, Peter Chin, Steven Ochs, Andrew Hirsh, Michael Trotter, and Thomas Mueller Steven Gange*Steven Gange* More articles by this author , Ansar KhanAnsar Khan More articles by this author , Gregg EureGregg Eure More articles by this author , Peter WalterPeter Walter More articles by this author , Charles ChabertCharles Chabert More articles by this author , Paul CozziPaul Cozzi More articles by this author , Doug GrierDoug Grier More articles by this author , Manish PatelManish Patel More articles by this author , Sheldon FreedmanSheldon Freedman More articles by this author , Peter ChinPeter Chin More articles by this author , Steven OchsSteven Ochs More articles by this author , Andrew HirshAndrew Hirsh More articles by this author , Michael TrotterMichael Trotter More articles by this author , and Thomas MuellerThomas Mueller More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000555954.91393.d0AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: Recent clinical trials reveal significant advantages Prostatic Urethra Lift (PUL) provides patients suffering from LUTS/BPH, however few studies have evaluated outcomes in the real world. The objective of this study was to examine results of PUL within the largest unconstrained patient population. Analysis was also performed on site of service to assess procedural safety in an office setting. METHODS: Retrospective chart review of 1,423 consecutive patients who received PUL across 14 sites in North America and Australia was performed. Symptom response (IPSS), quality of life (QoL) and peak flow rate (Qmax) were assessed at 1, 3, 6, 12 and 24 months post-procedure for the following cohorts: (1) total study population; (2) subjects with baseline IPSS ≥ 13. Patient follow up was analyzed using paired t-tests and 95% mean confidence intervals. IPSS outcomes from cohort 2 were compared to L.I.F.T. results at all timepoints. Incidence of post-procedural catheterization, surgical intervention and adverse events was analyzed and summarized descriptively. RESULTS: Compared to L.I.F.T, subjects in the real-world registry were older (70 years, p<0.01), had lower baseline IPSS (19.2, p<.0001), QoL (4.0, p<.0001) and higher Qmax (12.6, p<.0001) scores. Following PUL, mean IPSS for cohort 1 improved significantly at all timepoints by at least 8.1 points (Table 1, p<.0001). QoL improved by an average of 42% and Qmax improvement ranged from 15-36% (Table 1). Cohort 2 IPSS improvement was not significantly different compared to subjects from L.I.F.T. 61 surgical retreatments (excluding subjects with baseline urinary retention, prostate cancer and prostate size >80cc) occurred. Most adverse events were mild to moderate and transient. In the USA, 449 of 1146 (39%) procedures were performed in a clinic office, and 74.2% (333/449) were conducted using only local anesthesia. No significant differences in symptom outcomes and adverse events were observed between procedures conducted in the clinic office versus other settings. CONCLUSIONS: The first ever analysis of patients who received PUL in a commercial setting demonstrates efficacy and implementation consistent with previous clinical studies. Site of service in the clinic office does not appear to change symptom response and safety. Source of Funding: Neotract/Teleflex Inc. Salt Lake City, UT; Fremont, NE; Virginia Beach, VA; Cheektowaga, NY; Benowa, Australia; Hurstville, Australia; Edmonds, WA; Elgin, SC; Las Vegas, NV; Wollongong, Australia; Canton, OH; Somers, NJ; Austin, TX; Voorhees, NJ© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e465-e465 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information Steven Gange* More articles by this author Ansar Khan More articles by this author Gregg Eure More articles by this author Peter Walter More articles by this author Charles Chabert More articles by this author Paul Cozzi More articles by this author Doug Grier More articles by this author Manish Patel More articles by this author Sheldon Freedman More articles by this author Peter Chin More articles by this author Steven Ochs More articles by this author Andrew Hirsh More articles by this author Michael Trotter More articles by this author Thomas Mueller More articles by this author Expand All Advertisement PDF downloadLoading ...

Introduction: This study expands results from recent prostatic urethral lift (PUL) clinical trials by examining outcomes within a large unconstrained multicenter data set. Methods: Retrospective chart review and analysis of 1413 consecutive patients who received PUL in North America and Australia was performed. International Prostate Symptom Score (IPSS), quality of life (QoL), and maximum urinary flow rate (Qmax) were evaluated at 1, 3, 6, 12, and 24 months post-procedure for all nonurinary retention subjects (Group A) and retention subjects (Group B). Within Group A outcomes were further analyzed using paired t-tests and 95% mean confidence intervals under the following parameters: IPSS baseline ≥13, age, prostate size, site of service, prostate cancer treatment, and diabetic status. Adverse events, surgical interventions, and catheterization rates were summarized in detail. Results: Compared with the randomized controlled prosatic urethral lift (L.I.F.T.) study, subjects in this retrospective study were older and less symptomatic. After PUL, mean IPSS for Group A improved significantly from baseline by at least 8.1 points throughout follow-up. No significant differences were observed between Group A and B follow-up symptom scores. Within Group A, subjects with an IPSS baseline ≥13 behaved similarly to L.I.F.T. subjects. Age, prostate volume, site of service, prior cancer treatment, and diabetic status did not significantly affect PUL outcomes. When completed in a clinic office, PUL resulted in less side effects and catheter placement compared to other sites of service. Previous prostate cancer treatment did not elevate adverse events of high concern such as incontinence and infection. Conclusion: PUL performs well in a real-world setting in terms of symptom relief, morbidity, and patient experience for all studied patient cohorts.

BACKGROUND:The endothelial glycocalyx, a sieve-like structure located on the luminal surface of all blood vessels, has been found to be integral to regulation of capillary permeability and mechanotransduction. Given this, we investigated the role of endothelial glycocalyx breakdown products in organ donors and recipients in terms of acceptability for transplant and risk of primary graft dysfunction (PGD).METHODS:Endothelial glycocalyx breakdown products were measured in the peripheral blood of 135 intended and actual organ donors. Breakdown product levels were tested for association with donor demographic and clinical data, organ acceptability for transplant along with lung recipient outcomes (n = 35). Liquid chromatography mass spectrometry analysis was performed to confirm glycosaminoglycan levels and sulfation patterns on donor samples (n = 15). In transplant recipients (n = 50), levels were measured pretransplant and daily for 4 days posttransplant. Levels were correlated with PGD severity and intubation time.RESULTS:Decreased hyaluronan levels in peripheral blood independently predicted organ acceptability in intended and actual donors (odds ratio, 0.96; [95% confidence interval, 0.93-0.99] P = 0.026). Furthermore, high donor syndecan-1 levels were associated with PGD in recipients (3142 [1575-4829] versus 6229 [4009-8093] pg/mL; P = 0.045). In recipient blood, levels of syndecan-1 were correlated with severe (grades 2-3) PGD at 72 hours posttransplant (5982 [3016-17191] versus 3060 [2005-4824] pg/mL; P = 0.01).CONCLUSIONS:Endothelial glycocalyx breakdown occurs in lung transplant donors and recipients and predicts organ acceptability and development of PGD. Glycocalyx breakdown products may be useful biomarkers in transplantation, and interventions to protect the glycocalyx could improve transplant outcomes.