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

Conditions

• Bladder Cancer Requiring Cystectomy
• Ureteral Stents

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ureteral stents — DEVICE
  standard of care single-J externalized ureteral stents to be placed at time of radical cystectomy
• no ureteral stent — DEVICE
  no ureteral stents used at time of radical cystectomy

Study Details

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.

Key Dates

First listed

Jun 17, 2026

Start date

Sep 1, 2026

Status verified

Aug 2026

Primary completion

Jun 30, 2029

Completion

Aug 31, 2029

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: ureteral stents placed at time of cystectomy
  standard of care ureteral stent placement at time of radical cystectomy (control arm)
• Experimental: stent-free, no stent placement at time of cystectomy
  forgo ureteral stent placement at time of radical cystectomy (intervention arm)

Primary Outcome Measure

Post-operative readmission rate [ Time Frame: 30-days after surgery ]

Locations (1)

Find similar trials in Boston, MA

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