Ureteral stent versus no stent for adults having radical cystectomy with an ileal conduit
Official title: Randomized Controlled Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy
Run by Thomas Jefferson University · NCT07234968 · Data updated 2026-11-12
This trial tests whether placing temporary ureteral stents at the time of radical cystectomy with ileal conduit reduces post-operative complications compared with not placing stents in adults having cystectomy for bladder or other pelvic cancers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Thomas Jefferson University Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Status | Recruiting |
| Started | December 23, 2025 |
| Main results expected | April 30, 2028 |
| Study ends | April 30, 2028 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT07234968 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–85 who are scheduled for radical cystectomy with ileal conduit for bladder or other pelvic malignancies, can consent and attend follow-up, and do not have recent pelvic radiation or an untreated UTI are ideal candidates.
✕Probably not a fit
Patients with prior pelvic radiation, retroperitoneal fibrosis, untreated urinary tract infection, pregnancy, or those receiving other types of urinary diversion are unlikely to benefit or be eligible for this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective randomized trial assigning patients 1:1 to receive intraoperative ureteral stents or no stents during radical cystectomy with ileal conduit, with randomization stratified by surgical approach (open, robotic, or hybrid). Stents, when placed, are removed typically between 7 and 21 days post-operatively at the surgeon's discretion. Participants follow standard clinical care and are seen at 30 days, 3 months, 6 months, and 12 months after surgery, with additional visits if stent replacement or interventions are needed. The study will compare rates of post-operative complications such as urinary leak, urinary tract infection, need for re-intervention, and related morbidity over a 12-month follow-up period.
Why it matters
Potential benefit: If successful, the approach could reduce urinary leaks, infections, and reoperations after cystectomy and improve post-operative recovery.
How similar studies have gone: Existing observational and institutional reports show mixed results on routine stent use and randomized evidence is limited, so this trial addresses an evidence gap.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States Recruiting -
Jefferson Einstein Philadelphia Hospital
Philadelphia, Pennsylvania, United States Not yet recruiting
Study contacts
- Principal investigator: Mihir S Shah, MD — Thomas Jefferson University
- Study coordinator: Mihir S Shah, MD
- Email: Mihir.Shah@jefferson.edu
- Phone: 215-955-6961
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.