Browsing by Author "Rivera, Marcelino"

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    Comparison of Contemporary Surgical Outcomes Between Holmium Laser Enucleation of the Prostate and Robotic-Assisted Simple Prostatectomy
    (Springer Nature, 2023) Shelton, T. Max; Drake, Connor; Vasquez, Ruben; Rivera, Marcelino; Urology, School of Medicine
    Purpose of review: This study reviews contemporary literature on RASP and HoLEP to evaluate perioperative outcomes, common complications, cost analytics, and future directions of both procedures. Recent findings: RASP is indicated for prostates > 80 mL, while HoLEP is size-independent. No notable differences were found in operative time, PSA nadir (surrogate for enucleation volume), re-catheterization rates, or long-term durability. Prolonged incontinence and bladder neck contracture rates are low for both surgeries. Patients experience similar satisfaction outcomes and improvements in uroflowmetry and post-void residual volumes. HoLEP demonstrates shorter hospitalizations, lower transfusion rates, lower costs, and higher rates of same-day discharge. RASP offers a shorter learning curve and lower rates of early postoperative urinary incontinence. HoLEP is a size-independent surgery that offers advantages for patients seeking a minimally invasive procedure with the potential for catheter-free same-day discharge. Future directions with single-port simple prostatectomy may offer parity in same-day discharge, but further research is needed to determine broader feasibility.
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    Durability of Response to Primary Chemoablation of Low-Grade Upper Tract Urothelial Carcinoma Using UGN-101, a Mitomycin-Containing Reverse Thermal Gel: OLYMPUS Trial Final Report
    (AUA, 2022-04) Matin, Surena F.; Pierorazio, Phillip M.; Kleinmann, Nir; Gore, John L.; Shabsigh, Ahmad; Hu, Brian; Chamie, Karim; Godoy, Guilherme; Hubosky, Scott G.; Rivera, Marcelino; O'Donnell, Michael; Quek, Marcus; Raman, Jay D.; Knoedler, John J.; Scherr, Douglas; Weight, Christopher; Weizer, Alon; Woods, Michael; Kaimakliotis, Hristos; Smith, Angela B.; Linehan, Jennifer; Coleman, Jonathan; Humphreys, Mitchell R.; Pak, Raymond; Lifshitz, David; Verni, Michael; Klein, Ifat; Konorty, Marina; Strauss-Ayali, Dalit; Hakim, Gil; Seltzer, Elyse; Schoenberg, Mark; Lerner, Seth P.; Urology, School of Medicine
    Purpose: Our goal was to evaluate long-term safety and durability of response to UGN-101, a mitomycin-containing reverse thermal gel, as primary chemoablative treatment for low-grade upper tract urothelial carcinoma. Materials and Methods: In this open-label, single-arm, multicenter, phase 3 trial (NCT02793128), patients ≥18 years of age with primary or recurrent biopsy-proven low-grade upper tract urothelial carcinoma received 6 once-weekly instillations of UGN-101 via retrograde catheter to the renal pelvis and calyces. Those with complete response (defined as negative ureteroscopic evaluation, negative cytology and negative for-cause biopsy) 4–6 weeks after the last instillation were eligible for up to 11 monthly maintenance instillations and were followed for ≥12 months with quarterly evaluation of response durability. Durability of complete response was determined by ureteroscopic evaluation; duration of response was estimated by the Kaplan-Meier method. Treatment-emergent adverse events (TEAEs) were monitored. Results: Of 71 patients who initiated treatment, 41 (58%) had complete response to induction therapy and consented to long-term followup; 23/41 patients (56%) remained in complete response after 12 months (95% CI 40, 72), comprising 6/12 (50%) who did not receive any maintenance instillations and 17/29 (59%) who received ≥1 maintenance instillation. Kaplan-Meier analysis of durability was estimated as 82% (95% CI 66, 91) at 12 months. Ureteric stenosis was the most frequently reported TEAE (31/71, 44%); an increasing number of instillations appeared to be associated with increased incidence of urinary TEAEs. Conclusions: Durability of response to UGN-101 with or without maintenance treatment is clinically meaningful, offering a kidney-sparing therapeutic alternative for patients with low-grade disease.
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    Initial Experience with Novel Single-Use Disposable Ureteroscopy: A Prospective, Single Arm 90-Day Trial of the Axis Ureteroscope
    (AUA, 2021) Large, Tim; Rivera, Marcelino; Nottingham, Charles; Agarwal, Deepak; Mellon, Matthew; Krambeck, Amy; Urology, School of Medicine
    Introduction: Novel digital disposable ureteroscopes are becoming more commonplace in endourological practices. We trialed the Axis™ single-use ureteroscope, which is distributed within the United States by Dornier MedTech. Our goal was to demonstrate clinical equivalence to our reusable platform and to evaluate the cost-effectiveness of a single-use digital ureteroscope. Methods: We conducted a prospective 90-day trial where all flexible ureteroscopic procedures were completed using the single-use ureteroscope. The cases were monitored for scope failure, scope deficiencies and surgeon satisfaction scores via an immediate postoperative REDCap® survey. We also performed a cost analysis between reusable scopes and the single-use ureteroscope. The cost of the reusable platform included the amortized initial purchase, maintenance and clean processing. Results: Over a 90-day period, we performed 93 flexible ureteroscopy procedures with a single-use ureteroscope, of which 74 were completed using Axis. After controlling for operating room time and disposable items used, the utilization of Axis was associated with an average reduction of $140.31 per case. Extrapolating the per-case savings over an annual case volume, we estimate a total savings of $56,127.15. There were no disposable scope malfunctions. There were 4 (4.3%) cases converted to reusable scopes due to image quality (1), inadequate secondary deflection (2) and a tight ureter (1). Mean±SD score for image quality, mobility and ergonomics was 9.1±1.1, 8.9±1.1, 9.3±1.1, respectively. The 90-day complication rates were equal to our controls. Conclusions: We demonstrated that the Axis single-use digital ureteroscope is equivalent in function to our digital reusable scope and reduced the cost of flexible ureteroscopy.
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    Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial
    (Mary Ann Liebert, 2021-11) Large, Tim; Nottingham, Charles; Brinkman, Ethan; Agarwal, Deepak; Ferrero, Andrea; Sourial, Michael; Stern, Karen; Rivera, Marcelino; Knudsen, Bodo; Humphreys, Mitchel; Krambeck, Amy; Urology, School of Medicine
    Introduction: Currently, there are multiple intracorporeal lithotripters available for use in percutaneous nephrolithotomy (PCNL). This study aimed to evaluate the efficiency of two novel lithotripters: Trilogy and ShockPulse-SE. Materials and Methods: This is a prospective multi-institutional randomized trial comparing outcomes of PCNL using two novel lithotripters between February 2019 and June 2020. The study assessed objective measures of stone clearance time, stone clearance rate, device malfunction, stone-free rates, and complications. Device assessment was provided through immediate postoperative survey by primary surgeons. Results: There were 100 standard PCNLs completed using either a Trilogy or ShockPulse-SE lithotrite. Using quantitative Stone Analysis Software to estimate stone volume, the mean stone volume was calculated at 4.18 ± 4.79 and 3.86 ± 3.43 cm3 for the Trilogy and ShockPulse-SE groups, respectively. Stone clearance rates were found to be 1.22 ± 1.67 and 0.77 ± 0.68 cm3/min for Trilogy vs ShockPulse-SE (p = 0.0542). When comparing Trilogy to ShockPulse-SE in a multivariate analysis, total operative room time (104.4 ± 48.2 minutes vs 121.1 ± 59.2 minutes p = 0.126), rates of secondary procedures (17.65% vs 40.81%, p = 0.005), and device malfunctions (1.96% vs 34.69%, p < 0.001) were less, respectively. There was no difference in final stone-free rates between devices. Conclusion: Both the Trilogy and ShockPulse-SE lithotripters are highly efficient at removing large renal stones. In this study, we noted differences between the two devices including fewer device malfunctions when Trilogy device was utilized.
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    Outcomes of octogenarians undergoing holmium laser enucleation of prostate
    (Springer, 2022-07) Heiman, Joshua; Agarwal, Deepak; Komanapalli, Sarah; Nottingham, Charles; Large, Tim; Krambeck, Amy; Rivera, Marcelino; Urology, School of Medicine
    Purpose Holmium laser enucleation of prostate (HoLEP) is an effective surgical procedure in men with BPH. Due to the increase in the use of medical therapy for BPH related lower urinary symptoms more octogenarians are presenting in a delayed fashion with significant symptoms and urinary retention. We evaluate the feasibility and safety of octogenarians undergoing HoLEP. Methods We performed a retrospective review of HoLEPs at our institution from July 2018 to December 2019. Patients were stratified into two groups based on age: < 80 and ≥ 80. Results A total of 458 patients were identified, with 74 (16.2%) ≥ 80. In patients ≥ 80, prostate volume was higher (p < 0.0005), there was a higher rate of antiplatelet/anticoagulation (p = 0.029) use, and a lower rate of alpha-blocker use (p = 0.0016). As expected, ASA scores which correlate with increasing number of concomitant diseases were greater in the ≥ 80 cohort (p = 0.016). There was no significant difference in intraoperative complications (p = 0.14), 90 day complication (p = 0.34), readmission rates (p = 0.425) or emergency room visits between groups (p = 0.15). Conclusions Despite higher medical comorbidities and increased rates of anticoagulation in octogenarians, there is no increase in operative or postoperative complication rates. Age alone should not be used as exclusion criteria for HoLEP.
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    Same-Session Bilateral Ureteroscopy: Safety and Outcomes
    (Elsevier, 2017) Ingimarsson, Johann P.; Rivera, Marcelino; Knoedler, John J.; Krambeck, Amy E.; Department of Urology, School of Medicine
    Objective To assess the complications and outcomes associated with same-session bilateral ureteroscopy in a tertiary referral center, as same-session bilateral ureteroscopy for stone disease has been critiqued for the theoretical risk of injury to both ureters with subsequent risk to renal function. Methods We retrospectively reviewed all cases of bilateral ureteroscopy performed for urolithiasis by a single surgeon at out institution between 2009 and 2014. These were compared to a prospective unilateral ureteroscopy database. Results There were 117 same-session bilateral ureteroscopic procedures performed in 113 patients totaling 234 ureteroscopies. A flexible ureteroscope was used in 228 ureters (97.4%), and 6 (2.6%) were semirigid only. Ureteral dilators were required in 8 (6.8%) cases. Pre-stenting was performed in 23 (19.6%) patients. Short-term complications were observed following 19 (16.2%) procedures, including 11 (9.4%) Clavien I, 4 (3.4%) Clavien II, and 4 (3.4%) Clavien III. Of the 84 (71.8%) patients who completed a 6-week follow-up, there were no long-term complications. Stone-free rates were 91.4% for patients imaged with abdominal x-ray and ultrasound, and 84.2% for those imaged with computed tomography scans. Neither complications nor re-admissions were significantly different in the unilateral group. Median length of follow-up for the entire cohort was 2.8 years (range 0-7 years). Conclusion Bilateral ureteroscopy can be performed safely with short-term complications, consistent with published literature. We found no long-term complications and high stone-free rates. Bilateral ureteroscopy in a single procedure represents a viable standard of care for patients with bilateral stone disease.
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    The Uniform grading tooL for flexIble ureterorenoscoPes (TULIP-tool): a Delphi consensus project on standardised evaluation of flexible ureterorenoscopes
    (Wiley, 2023) Henderickx, Michaël M. E. L.; Hendriks, Nora; Baard, Joyce; Wiseman, Oliver J.; Scotland, Kymora B.; Somani, Bhaskar K.; Şener, Tarik E.; Emiliani, Esteban; Dragos, Laurian B.; Villa, Luca; Talso, Michele; Hamri, Saeed Bin; Proietti, Silvia; Doizi, Steeve; Traxer, Olivier; Chew, Ben H.; Eisner, Brian H.; Monga, Manoj; Hsi, Ryan S.; Stern, Karen L.; Leavitt, David A.; Rivera, Marcelino; Wollin, Daniel A.; Borofsky, Michael; Canvasser, Noah E.; Ingimarsson, Johann P.; El Tayeb, Marawan M.; Bhojani, Naeem; Gadzhiev, Nariman; Tailly, Thomas; Durutovic, Otas; Nagele, Udo; Skolarikos, Andreas; Schout, Barbara M. A.; Beerlage, Harrie P.; Pelger, Rob C. M.; Kamphuis, Guido M.; Urology, School of Medicine
    Objective: To develop a standardised tool to evaluate flexible ureterorenoscopes (fURS). Materials and methods: A three-stage consensus building approach based on the modified Delphi technique was performed under guidance of a steering group. First, scope- and user-related parameters used to evaluate fURS were identified through a systematic scoping review. Then, the main categories and subcategories were defined, and the expert panel was selected. Finally, a two-step modified Delphi consensus project was conducted to firstly obtain consensus on the relevance and exact definition of each (sub)category necessary to evaluate fURS, and secondly on the evaluation method (setting, used tools and unit of outcome) of those (sub)categories. Consensus was reached at a predefined threshold of 80% high agreement. Results: The panel consisted of 30 experts in the field of endourology. The first step of the modified Delphi consensus project consisted of two questionnaires with a response rate of 97% (n = 29) for both. Consensus was reached for the relevance and definition of six main categories and 12 subcategories. The second step consisted of three questionnaires (response rate of 90%, 97% and 100%, respectively). Consensus was reached on the method of measurement for all (sub)categories. Conclusion: This modified Delphi consensus project reached consensus on a standardised grading tool for the evaluation of fURS - The Uniform grading tooL for flexIble ureterorenoscoPes (TULIP) tool. This is a first step in creating uniformity in this field of research to facilitate future comparison of outcomes of the functionality and handling of fURS.
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    Uncovering a Novel Stone in 27 Patients: Calcium Tartrate Tetrahydrate
    (Elsevier, 2019) Kleinguetl, Colin; Williams, James C., Jr.; Lieske, John; Daudon, Michel; Rivera, Marcelino; Janneto, Paul; Bornhorst, Joshua; Rokke, Denise; Bird, Erin T.; Lingeman, James E.; El Tayeb, Marawan M.; Anatomy and Cell Biology, IU School of Medicine
    Objective To further analyze calcium tartrate tetrahydrate stones after a recent case report described this novel stone. Prior to this, there was only one previously reported occurrence of this stone in a human. This unusual stone composition is not tested for routinely. True prevalence and possible causes of this stone are unknown. Materials/Methods During the previous case report, micro-CT and Fourier-transform infrared spectroscopy were used to identify a calcium tartrate tetrahydrate stone. This information was applied to urinary stones with previously unidentified compositions in the Mayo Metals laboratory database between 2010 and March 2018. Two additional stones were identified at our institution. Three patients had medical records available for analysis. Results Between 2010 and March 2018, 35 calcium tartrate stones in 25 patients were identified in the Mayo database as well as 2 at our institution (37 stones in 27 patients). Thirty stones were pure calcium tartrate with the remainder having elements of more common stones. The average age was 46.3 (±14.7) with a slightly higher incidence in females (17 vs 10). Of the 3 medical records investigated, all 3 were males (average age 48.7), and each reported consumption of an energy supplement (Spark) routinely. Conclusion The true prevalence of this relatively unknown stone remains unclear and additional investigation is warranted. We believe all stone laboratories should have access to the IR spectra for calcium tartrate tetrahydrate. Attention should be paid to possible causes of this stone, particularly with relation to oral supplements, to aid with future prevention and treatment.