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Study on Ureteral Stent Use During Bladder Cancer Surgery

This study is looking at whether placing a ureteral stent (a small tube that helps urine flow from the kidney to the bladder) during surgery for bladder cancer affects recovery. The surgery is called a radical cystectomy with ileal conduit urinary diversion (RCIC), which removes the bladder and creates a new way for urine to leave the body. You would be randomly assigned to either receive a ureteral stent during your surgery or not. Researchers will then compare the number of urinary tract infections (UTIs) in both groups 90 days after surgery. This study is open to men and women aged 18 to 85 who have been diagnosed with bladder cancer or other pelvic cancers requiring this surgery. The study is currently recruiting about 70 participants, but its exact status is unclear.

Study design
This study is an interventional trial where participants are randomly assigned to one of two groups: receiving a ureteral stent or not receiving one during surgery. Approximately 70 participants will be enrolled.
What's involved
If you join, you will undergo radical cystectomy with ileal conduit urinary diversion (RCIC). You will have follow-up visits within 30 days, 3 months, 6 months, and 12 months after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after their surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07234968

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

Recruiting
NAAges 18–85InterventionalTreatment
Thomas Jefferson University
~70 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:Ureteral Stent PlacementNo Ureteral StentIndocyanine Green with Fluorescence Imaging

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of urinary tract infection (UTI)
Measured over 90 days after surgery

Conditions

Bladder Cancer
Muscle-Invasive Bladder Carcinoma
Urothelial Carcinoma
Pelvic Malignancy
Bladder Transitional Cell Carcinoma
Bladder Neoplasm

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Where it's being run

2 sites across 1 states
Pennsylvania2

Study leadership

  • Mihir S Shah, MD · PRINCIPAL_INVESTIGATOR · Thomas Jefferson University

Who to contact

Mihir S Shah, MD
[email protected]
215-955-6961
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of urinary tract infection (UTI)90 days after surgery

    UTI is defined as clinical symptoms consistent with UTI as well as a positive urine culture showing ≥ 10⁵ CFU/mL of a uropathogen. Subjects who do not complete the 90-day follow-up period but had no evidence of infection at last follow-up will be excluded from the analysis. the Mantel-Haenszel stratified-adjusted estimate of the risk difference for incidence of urinary tract infection (risk in no stent arm - risk in stent arm) will be estimated along with one-sided (upper bound) 80% confidence interval.