Browsing by Author "Humphreys, Mitchell R."

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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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    Outcomes of Holmium Laser Enucleation of the Prostate in the Re-Treatment Setting
    (Elsevier, 2017-06) Marien, Tracy; Kadihasanoglu, Mustafa; Tangpaitoon, Teerayut; York, Nadya; Blackburne, Andrew T.; Abdul-Muhsin, Haidar; Borofsky, Michael S.; Krambeck, Amy E.; Humphreys, Mitchell R.; Lingeman, James E.; Miller, Nicole L.; Department of Urology, IU School of Medicine
    Purpose Holmium laser enucleation of the prostate can also be applied in the re-treatment setting when other benign prostatic hyperplasia therapies fail. We compared outcomes in men who underwent holmium laser enucleation of the prostate in the primary vs the re-treatment setting. Materials and Methods We retrospectively reviewed the records of 2,242 patients who underwent holmium laser enucleation of the prostate at a total of 4 academic hospitals between 2003 and 2015. Patient demographics, and operative and perioperative outcomes were compared between re-treatment and primary holmium laser enucleation of the prostate. Results Of the 360 of 2,242 men (16%) who underwent re-treatment holmium laser enucleation of the prostate the procedure was done for residual urinary symptoms in 71%. The most common primary procedure was transurethral resection of the prostate in 42% of cases. Mean time between prior benign prostatic hyperplasia surgery and re-treatment was 68 months (range 1 to 444). There were no significant differences in age, prostate size, AUA (American Urological Association) symptom score or average flow rate between the cohorts. Perioperatively, re-treatment holmium laser enucleation of the prostate was associated with significantly shorter operative time, reduced blood loss, lower specimen weight and shorter length of stay. The AUA symptom score improved in both groups, although it remained higher in men who underwent re-treatment (6.5 vs 5.0, p <0.001). The likelihood of clot retention (4.7% vs 1.8%, p = 0.01) and urethral stricture (3.3% vs 1.5%, p = 0.043) was slightly higher in the re-treatment group. Conclusions Immediate perioperative outcomes of holmium laser enucleation of the prostate performed in the re-treatment setting were no different from those in the primary setting. While re-treatment was associated with an increased likelihood of clot retention, urethral stricture and higher AUA symptom score, these minimal differences must be considered against the overall favorable symptom improvement across both cohorts.
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    Randomized controlled trial comparing three different modalities of lithotrites for intracorporeal lithotripsy in pcnl
    (Liebert, 2017) York, Nadya E.; Borofsky, Michael S.; Chew, Ben H.; Dauw, Casey A.; Paterson, Ryan F.; Denstedt, John D.; Razvi, Hassan; Nadler, Robert B.; Humphreys, Mitchell R.; Preminger, Glenn M.; Nakada, Stephen Y.; Krambeck, Amy E.; Miller, Nicole L.; Terry, Colin; Rawlings, Lori D.; Lingeman, James E.; Department of Urology, School of Medicine
    Purpose: To compare the efficiency (stone fragmentation and removal time) and complications of three models of intracorporeal lithotripters in percutaneous nephrolithotomy (PCNL). Materials and Methods: Prospective, randomized controlled trial at nine centers in the North America from 2009 to 2016. Patients were randomized to one of three lithotripter devices: the Cyberwand, a dual probe ultrasonic device; the Swiss Lithoclast Select, a combination pneumatic and ultrasonic device; and the StoneBreaker, a portable pneumatic device powered by CO2 cartridges. Since the StoneBreaker lacks an ultrasonic component, it was used with the LUS‐II ultrasonic lithotripter to allow fair comparison with combination devices. Results: 270 patients were enrolled, 69 were excluded after randomization. 201 patients completed the study: 71 in the Cyberwand group, 66 in the Lithoclast Select, and 64 in the StoneBreaker group. The baseline patient characteristics of the three groups were similar. Mean stone surface area was smaller in the StoneBreaker group at 407.8mm2 vs 577.5mm2 (Lithoclast Select) and 627.9mm2 (Cyberwand). The stone clearance rate was slowest in the StoneBreaker group at 24.0 mm2/min vs 28.9 mm2/min and 32.3 mm2/min in the Lithoclast Select and Cyberwand groups respectively. After statistically adjusting for the smaller mean stone size in the StoneBreaker group, there was no difference in the stone clearance rate among the three groups (p=0.249). Secondary outcomes, including complications and stone free rates, were similar between the groups. Conclusions: The Cyberwand, Lithoclast Select, and the StoneBreaker lithotripters have similar adjusted stone clearance rates in PCNL for stones > 2cm. The safety and efficacy of these devices are comparable.