Recruiting

Stent

Sponsor:

Thomas Jefferson University

Code:

NCT07234968

Conditions

Bladder Cancer

Muscle-Invasive Bladder Carcinoma

Urothelial Carcinoma

Pelvic Malignancy

Bladder Transitional Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ureteral Stent Placement

No Ureteral Stent

Indocyanine Green with Fluorescence Imaging

Study Details

Brief summary:

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.

Conditions

Bladder Cancer

Muscle-Invasive Bladder Carcinoma

Urothelial Carcinoma

Pelvic Malignancy

Bladder Transitional Cell Carcinoma

Study ID

NCT07234968

Start date

Dec 23, 2025

Status verified date

Feb, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1: Ureteral Stent

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.

active comparator: Arm 2: No Ureteral Stent

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.

Interventions

Ureteral Stent Placement

Placement of ureteral stents (double J or single J) intraoperatively during radical cystectomy with ileal conduit urinary diversion (RCIC). Stent placement will be a one-time occurrence inserted during RCIC, and be removed typically between 7-21 days post-op at the discretion of the surgeon.

No Ureteral Stent

Radical cystectomy with ileal conduit urinary diversion (RCIC) performed without ureteral stent placement.

Indocyanine Green with Fluorescence Imaging

Indocyanine green (ICG) with fluorescence imaging is an advanced technique used to enhance the visualization of the ureters during complex pelvic surgeries, such as those for bladder cancer. The technology helps surgeons identify the ureters, which are the tubes connecting the kidneys to the bladder, and distinguish them from surrounding tissues.

Primary outcome measure

  • Number of urinary tract infection (UTI) [ Time Frame: 90 days after surgery ]

Central Contacts and Locations

Central contacts

Locations

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Mihir S Shah, MD

215-955-6961

More Information

Sponsor

Thomas Jefferson University

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • Bladder
  • Stent-free Cystectomy
  • Urinary Tract Infection
  • Urinary Leak
  • UTI
  • Pelvic Malignancy
  • Bladder Cancer
  • Urologic Oncology
  • Muscle-invasive Bladder Cancer
  • indocyanine green
  • fluorescence imaging
  • ureteral stents
  • RCIC
  • cystectomy
  • colorectal
  • prostate
  • gynecologic
  • ileal conduit urinary diversion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2026-02-17.