Phase 3 STENT X compares ureteral stent device vs stent-free reconstruction (peri-anastomotic support)

Brigham and Women’s Hospital (Mass General Brigham) is running this Phase 3, prospective, randomized, multi-institution trial testing a very practical surgical question after radical cystectomy for bladder cancer: should surgeons place ureteral stents across the ureteroenteric anastomoses or omit them entirely. Participants undergoing radical cystectomy for muscle-invasive bladder cancer and selected high-risk non–muscle-invasive disease (both of which commonly proceed to cystectomy) are randomized to standard ureteral stent placement vs a stent-free approach; both ileal conduit and orthotopic neobladder diversions are allowed, and robotic or open approaches are permitted. The “interventions” are devices/technique choices (stents vs no stents)—there is no drug being tested here; the nitric-oxide vasodilator language appears to be erroneous/misplaced for this specific trial record. The key scientific/commercial angle is Level 1 evidence for a long-debated practice where retrospective data suggest stents may increase infectious morbidity despite their theoretical benefit for healing. Today’s care for these patients is radical cystectomy with pelvic lymph node dissection plus urinary diversion, with perioperative antibiotics and careful post-op monitoring; this study aims to reduce 30-day complications like UTIs/pyelonephritis, leaks, and later ureteroenteric strictures by optimizing the diversion technique.