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

NCT07655284 | Not Yet Recruiting Phase 3 FDA Device

• 1 other identifier: 2025P002187
• Study Type: interventional
• Target: 190
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Bladder Cancer Requiring Cystectomy; Ureteral Stents

Keywords

bladder cancer; cystectomy; ureteral stents

Outcome Measures

Primary Outcomes (1)

• Post-operative readmission rate

  percent of patients re-admitted

  30-days after surgery

Secondary Outcomes (8)

• length of stay

  30 days

• procedure duration

  30 days

• blood transfusion rate

  30 days

• Emergency room visits

  30 days

• patient reported pain on analog scale

  30 days

Study Arms (2)

ureteral stents placed at time of cystectomy

ACTIVE COMPARATOR

standard of care ureteral stent placement at time of radical cystectomy (control arm)

Device: ureteral stents

stent-free, no stent placement at time of cystectomy

EXPERIMENTAL

forgo ureteral stent placement at time of radical cystectomy (intervention arm)

Device: no ureteral stent

Interventions

ureteral stents DEVICE

standard of care single-J externalized ureteral stents to be placed at time of radical cystectomy

ureteral stents placed at time of cystectomy

no ureteral stent DEVICE

no ureteral stents used at time of radical cystectomy

stent-free, no stent placement at time of cystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Instituto do Câncer do Estado de São Paulo (ICESP)

São Paulo, São Paulo, 01246-000, Brazil

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Timothy N Clinton, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy N Clinton, MD

CONTACT

617-732-6384; tclinton1@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Surgeon

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); BR (1)