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

STENT X Non-stent Genito-urinary Tract Reconstruction After Radical Cystectomy for Bladder Cancer - a Prospective, Randomized, Controlled and Multi Institutional Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bladder Cancer Requiring Cystectomy; Ureteral Stents
• Intervention / Treatment: Device: ureteral stents; Device: no ureteral stent

Detailed Description

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. Randomization between ureteroenteric anastomosis with or without ureteral stent placement will occur at time of surgery; the surgeon will know this information at time of surgery and the patient will be aware of the placement of stents following surgery as these are externalized and visible. The primary outcome will be complication rate in 30 days after the surgery. Secondary outcomes of this trial will include: length of stay, procedure duration, emergency room visits, patient reported pain, anastomotic leakage rate, ureteral stricture rate, post-operative nephrostomy tube placement, differences in complication rates between interrupted and running suture technique. The study will be conducted across three academic institutions: Brigham and Women's Hospital (BWH), Massachusetts General Hospital (MGH) and Instituto do Câncer do Estado de São Paulo (ICESP), Brazil.

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Timothy N Clinton, MD; Phone Number: 617-732-6384; Email: tclinton1@bwh.harvard.edu

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 01246-000
      • Instituto do Câncer do Estado de São Paulo (ICESP)
      • Contact: Guilherme Garcia Barros, MD; Phone Number: +55 11 96350-7080; Email: guilhermegarcia.urologia@gmail.com
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
      • Contact: Timothy N Clinton, MD; Phone Number: 617-732-6384; Email: tclinton1@bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults (> 18 years old)
• Muscle invasive bladder cancer or non-muscle invasive bladder cancer with indication of Radical Cystectomy
• No concomitant surgeries like nephrectomies, colectomies or removal of other organs affected by the tumor (Except standard lymph node dissections as well as in men the prostate and seminal vesicles and in women the uterus, fallopian tubes, ovaries and vagina, that are considered part of the oncological radical cystectomy.)
• Patients who have the capacity to understand the study procedures and provide written informed consent

Exclusion Criteria:

• Simultaneous surgical procedures (except those specified in the inclusion criteria that are considered part of a routine radical cystectomy)
• History of prior urinary diversion
• Patients who decline to participate, lack understanding of the study's purpose, or are unable to provide informed consent
• Cystectomy for other reasons than Bladder cancer
• Previous radiation therapy in the pelvis for any reason
• Extremely debilitated patients, malnourished individuals, or those undergoing palliative or hygienic cystectomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ureteral stents placed at time of cystectomy; standard of care ureteral stent placement at time of radical cystectomy (control arm)	Device: ureteral stents; standard of care single-J externalized ureteral stents to be placed at time of radical cystectomy
Experimental: stent-free, no stent placement at time of cystectomy; forgo ureteral stent placement at time of radical cystectomy (intervention arm)	Device: no ureteral stent; no ureteral stents used at time of radical cystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative readmission rate	percent of patients re-admitted	30-days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of stay	index hospitalization (days after surgery until discharge, excluding pre-admission if applicable)	30 days
procedure duration	surgical time measured from incision to closing	30 days
blood transfusion rate	percent of patients requiring blood transfusion	30 days
Emergency room visits	percent of patients presenting to emergency room at least once after surgery	30 days
patient reported pain on analog scale	analog 0 to 10 scale	30 days
ureteral stricture rate	percent of patients developing ureteral stricture requiring intervention (e.g. nephrostomy tube placement)	30 days
urine leak rate	percent of patients developing urine leak requiring intervention (e.g. interventional radiology procedure)	30 days
pyelonephritis rate	percent of patients developing of urinary tract infection (defined by clinical sequelae of infection in setting of positive urinalysis requiring treatment with antibiotics)	30 days

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Timothy N Clinton, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: June 12, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: bladder cancer; cystectomy; ureteral stents
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 2025P002187

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: As part of IRB approval of the study decision was for privacy policy that only aggregated data would be intended to be shared outside the institutional system and any IPD would be solely stored on HIPAA compliant servers at the facility. De-identified or aggregated data would be permitted to be shared so long as subjects could not be identified.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No