Comparing Ureteral Stents With No Stents During Bladder Removal Surgery for Bladder Cancer
Compares using a ureteral stent or not during bladder removal surgery for bladder cancer.
Key facts
- Who runs it
- Thomas Jefferson University
- Where
- Philadelphia, United StatesSee the 2 sites
- Trial code
- Registry title
- Clinical Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy
- Status
- Recruiting
- People taking part
- 70 people, planned
- Started
- 23 Dec 2025
- Expected to end
- 30 Apr 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Ureteral Stent Placement
- No Ureteral Stent
- Indocyanine Green with Fluorescence Imaging
- Record updated
- 17 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who need a bladder removal operation (cystectomy) with an ileal conduit, a way to drain urine through a piece of bowel. People are randomly placed in a group with ureteral stents or without.
- Age
- 18 to 85 years
- Sex
- All sexes can join.
- Disease stage
- Bladder cancer or another cancer in the pelvis that needs the bladder removed. The person has chosen cystectomy with an ileal conduit urinary diversion.
- Earlier treatment
- Cannot have had radiation to the pelvis, now or in the past.
Main reasons for not taking part
- Current or past radiation to the pelvis
- Retroperitoneal fibrosis
- Untreated urinary tract infection (UTI) within 30 days before the surgery
- Pregnancy
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Where in United States
- Jefferson Einstein Philadelphia HospitalPhiladelphia, United StatesContact: Mihir S Shah, MDNot yet recruiting
- Thomas Jefferson University HospitalPhiladelphia, United StatesContact: Mihir S Shah, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Arm 1: Ureteral StentTreatment being tested
Subjects randomized to the stent arm will receive ureteral stents (double J or single J ureteral catheter, per surgeon preference) during radical cystectomy with ileal conduit urinary diversion (RCIC). Intraoperative use of indocyanine green with fluorescence imaging with be noted. Ureteral stents will be placed intraoperatively and removed at follow up visit per surgeon discretion. Either approach would be considered standard of care for muscle invasive bladder cancer, for which radical cystectomy with urinary diversion is the gold standard of treatment. 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.
Treatment: Ureteral Stent Placement and Indocyanine Green with Fluorescence Imaging
- Arm 2: No Ureteral StentExisting treatment, for comparison
Subjects randomized to the no-stent arm will undergo radical cystectomy with ileal conduit urinary diversion (RCIC) without placement of ureteral stents. 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.
Treatment: No Ureteral Stent and Indocyanine Green with Fluorescence Imaging
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Randomized Controlled Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy
- Plain-language title
- Comparing Ureteral Stents With No Stents During Bladder Removal Surgery for Bladder CancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07234968, who can take part
- Record updated
- 17 February 2026