Clinical Trial

STENT X: a Randomized Trial to Assess Stent-free Radical Cystectomy

Withdrawn Phase 3

Why the trial stopped

Study withdrawn prior to enrollment. Principle Investigator changed institutions prior to obtaining IRB approval.

Summary

Radical Cystectomy (RC) remains the gold standard for localized muscle-invasive bladder cancer (MIBC); however, use of ureteral stents at time of surgery remains controversial without level 1 evidence to comment on risks or benefits of their use. RC complications commonly include urinary tract infections (UTIs), pyelonephritis, ureteroileal leakage and stenosis, and can occur with either ileal conduit or orthotopic neobladder diversions. Traditionally, ureteral stents are thought to support anastomotic healing and reduce the risk of anastomotic leakage and strictures; however, emerging evidence from retrospective studies suggests that stent use may paradoxically increase rates of postoperative morbidity. This randomized, multicenter and prospective study aims to compare 30-day postoperative complication rates between stented and non-stented urinary diversions in patients undergoing RC for MIBC, in both ileal conduit or neobladder with either robotic or open approaches.

Protocol Amendment History 3 changes

critical Withdrawn before enrolling 2026-08-14

critical Trial withdrawn: Study withdrawn prior to enrollment. Principle Investigator changed institutions prior to obtaining IRB approval. 2026-08-14

notable Enrollment reduced: 190 -> 0 participants 2026-08-14

Trial Details

NCT Number	NCT07655284
Lead Sponsor	Brigham and Women's Hospital
Conditions	Bladder Cancer Requiring Cystectomy, Ureteral Stents
Start Date	2026-09-01
Primary Completion	2029-06-30 (estimated)
Study Completion	2029-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-13