Purpose:We reviewed the oncologic and surgical outcomes of endoscopic treatments for low-grade upper tract urothelial carcinoma (UTUC), and assessed the prognostic significance of tumor size, locat...

The aim of this study was to examine ureteral stricture rate after the use of UAS in an unstented ureter and compare complications of smaller vs. larger-caliber UAS. We conducted a retrospective analysis of consecutive RIRS for renal stones, with the use of UAS in unstented ureters. We excluded cases with previous ureteroscopies, who carried ureteral stent or nephrostomy, had impacted stones, underwent radiation treatment, or had urinary tract malignancies. The primary outcome was formation of ureteral strictures diagnosed by hydronephrosis in ultrasound test and late secretion in dynamic renal scan. Secondary outcome was stone-free-rate (SFR) and complications. In addition, we compared safety and efficacy of smaller (9.5/11.5Fr) vs. larger-caliber (12/14Fr) UAS. The cohort included 165 patients with a median follow-up time of 115 days. There was no case of ureteral stricture formation after the use us UAS, despite using a larger-caliber UAS in nearly half the cases. Larger-caliber UAS was not associated with more complications compared to the smaller-caliber one (p = 0.780). SFR was non-significantly higher in the larger-caliber UAS group (p = 0.056), despite having a larger stone burden, and only stone number was associated with SFR (p = 0.003). These data suggest that the use of UAS during RIRS in an unstented ureter is safe and does not involve ureteral stricture formation after one procedure. Furthermore, the use of wider sheaths was not found to be associated with higher complications rate.

Objectives: Malignant ureteral obstruction (MUO) is a devastating complication of cancer, and it is commonly treated by drainage via percutaneous nephrostomy (PCN). The objective of this study was to determine the efficacy, safety, and functional outcome of tandem ureteral stents (TUS) in the management of MUO. Materials and Methods: The medical records of all patients with MUO who underwent balloon dilation and TUS insertion in Sheba Medical Center between 2014 and 2018 were retrospectively analyzed. Safety was measured by intra- and postoperative complications, efficacy by time to event analysis, and failure by the requirement of PCN attributable to renal failure or infection. Independent risk predictors of TUS failure were determined by a multivariable Cox regression analysis. Results: A total of 103 procedures were performed on 81 patients during the study period. The median follow-up was 32 weeks (interquartile range [IQR] 24–67). Fifty-nine (72.9%) patients remained with TUS while 22 patients required PCNs. The median time to procedural failure was 4 months (IQR 2–8). Complications developed after 18 (22.2%) procedures. Two patients requested stent removal due to lower urinary tract symptoms. Independent predictors for TUS failure were metastasis (hazard ratio [HR] 3.03, 95% confidence interval [CI] 1.27, 7.23, p = 0.013) and prior PCN (HR 3.38, 95% CI 1.40, 8.13, p = 0.007). Conclusions: TUS is an efficient and safe management option for patients with MUO. It can alleviate renal failure without the need for an external PCN. Metastasis and prior PCN are associated with TUS failure.

Background: There is an unmet need for an effective local treatment of upper tract urothelial carcinoma (UTUC). Drug delivery to the pyelocaliceal system and pursuant efficacy of intracavitary therapy is limited by urine production that washes the drug away, shortening dwell time and direct contact with the urothelium. Successful endoscopic management is often dictated by lesion size, grade, and focality. A thermo-reversible hydrogel formulation of Mitomycin C (UGN-101, formerly MitoGel) was developed and has demonstrated the safety and feasibility of increased time of the drug in the pyelocaliceal system resulting in chemoablation of tumors. Objectives: To examine the efficacy and safety of UGN-101 used for chemoablation of UTUC. Methods: There were 22 patients approved for compassionate use treatment at 14 institutions. Six-weekly instillations of UGN-101 were administered via ureteral catheter or percutaneous nephrostomy. Ureteroscopy was performed 2–6 weeks following treatment completion for response determination. Adverse events were recorded throughout treatment. Patients were followed up according to the standard of care of each center. Results: Median age of the cohort was 75 yrs., with 16 (73%) males. Eighteen patients had low-grade (LG) tumors, 2 high-grade (HG), and 2 had indeterminate grade. Median volume of UGN-101 instilled was 13.5cc with median Mitomycin dosage of 54 mg. Eight patients had complete response (36%) including 44% (8/18) of the patients with low grade tumors. Partial responses were observed in 23% and 28% of LG. Two patients had no response (9%) and 1 did not undergo ureteroscopy. Four patients could not complete 6 weeks due to adverse events (pyelonephritis, acute renal failure, pancytopenia, and unstable cardiac condition); 1 patient was diagnosed with a non-urothelial cancer during treatment; and 1 patient died prior to the third instillation due to suspected pulmonary embolus, determined to be unrelated to treatment with UGN-101. Out of the patients who had a complete response, 3 (37.5%) patients are recurrence free from 18–30 months. A total of 83 adverse events were recorded. Of these, 6 events related to UGN-101 were serious (requiring medical intervention), and 23 events related to UGN-101 were not serious. Conclusions: This compassionate use program of UGN-101 demonstrates proof of concept for chemoablation treatment of UTUC. A single arm Phase III multi-center registration trial to treat patients with low-grade low-volume renal pelvis tumors is open and enrolling patients (NCT02793128).