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Clinical Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy

Randomized Controlled Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy

Who can join

Ages 18 to 85 · All sexes

Inclusion Criteria:

* Individuals must meet all the following inclusion criteria to be eligible to participate in the study:

  * Provide signed and dated informed consent form
  * Willing to comply with all study procedures and be available for the duration of the study
  * Male or female, age 18 to 85
  * Diagnosed with bladder cancer, other pelvic malignancies necessitating a cystectomy (e.g.: colorectal, prostate, gynecologic) and have elected for a cystectomy with ileal conduit urinary diversion

Exclusion Criteria:

* An individual who meets any of the following criteria will be excluded from participation in this study:

  * Current or history of pelvic radiation
  * Retroperitoneal fibrosis
  * Untreated urinary tract infection (UTI) within 30 days prior to RCIC
  * Pregnancy

About the study

Subjects will be randomized into 2 groups (stent or no stent) prior to radical cystectomy with ileal conduit urinary diversion (RCIC). They will follow the standard of care and be enrolled in the study for 12 months post-op. Risk of post-op complications will be analyzed.

What is being tested

• Ureteral Stent Placement (procedure)
• No Ureteral Stent (procedure)
• Indocyanine Green with Fluorescence Imaging (diagnostic test)

Sponsor: Thomas Jefferson University · Participants: 70 · Started: Dec 23, 2025

Contact the study team

• Mihir S Shah, MD · Phone: 215-955-6961

Official record on ClinicalTrials.gov — NCT07234968

Locations in the U.S.

Conditions

• Bladder Cancer
• Urothelial (Transitional Cell) Carcinoma
• Urinary Tract Infections

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.