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

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Cancer; Urothelial Carcinoma; Muscle-Invasive Bladder Carcinoma; Bladder Neoplasm; Bladder Transitional Cell Carcinoma; Pelvic Malignancy
• Intervention / Treatment: Procedure: Ureteral Stent Placement; Diagnostic test: Indocyanine Green with Fluorescence Imaging; Procedure: No Ureteral Stent

Detailed Description

Patients who are indicated for RCIC will be recruited for this prospective RCT. 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.

Patients will be randomized 1:1 to receive stent or no stent during RCIC (Stent: N=35, No Stent: N=35). Randomization will be stratified by surgical approach (open vs. robotic vs. hybrid). The randomization schedule will be created by the study statistician using the method of random permuted blocks.

Stent placement, if applicable, 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. For this study, subjects will continue to be followed for up to 1-year post-op. Subjects will be enrolled in this study for 12 months.

Post treatment, the patient will have a follow-up visit within 30 days post-operatively, 3 months follow-up visit (+/- 1 week), 6 months follow-up visit (+/- 21 days), and 12 months follow-up visit (+/- 21 days). Patient will be followed for 12 months post treatment or until their death. Additional visits or follow-ups may be indicated for instances of the need for replacement of ureteral stents and catheters or percutaneous nephrostomies. The need for surgical repair for a ureteral leak or stricture may also occur.

The Principal Investigator hypothesizes that patients with no ureteral stent placement during RCIC will not be associated with a higher risk of post-op complications compared to those with a ureteral stent.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mihir S Shah, MD; Phone Number: 215-955-6961; Email: Mihir.Shah@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University Hospital
      • Contact: Mihir S Shah, MD; Phone Number: 215-955-6961
    • Philadelphia, Pennsylvania, United States, 19141
      • Not yet recruiting
      • Jefferson Einstein Philadelphia Hospital
      • Contact: Mihir S Shah, MD; Phone Number: 215-955-6961

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: 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.; Other Names: ureteral stents; double J; single J; Diagnostic test: 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.; Other Names: ICG
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.	Diagnostic test: 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.; Other Names: ICG; Procedure: No Ureteral Stent; Radical cystectomy with ileal conduit urinary diversion (RCIC) performed without ureteral stent placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of urinary tract infection (UTI)	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.	90 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of urinary leak	Measurement will be the presence or absence of a urinary leak. Urinary leak will be identified through clinical symptoms, laboratory abnormalities, or imaging findings. Relevant assessments include vitals, laboratory testing (CBC and BMP/CMP), urinalysis, and imaging reports. Data will be aggregated as the number and percentage of participants with a urinary leak within the time frame.	90 days after surgery
Incidence of ureteral stricture	Measurement will be the presence or absence of ureteral stricture. Ureteral stricture will be identified through clinical symptoms, laboratory abnormalities, or imaging findings. Relevant assessments include vitals, laboratory testing (CBC and BMP/CMP), urinalysis, and imaging reports. Data will be aggregated as the number and percentage of participants with ureteral stricture within the time frame.	12 months after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of readmission	Measurement will be the presence or absence of hospital readmission. Readmission is defined as any unplanned hospital admission during follow-up. Assessments include vitals, adverse event review, labs, urinalysis, and imaging performed at the scheduled post-operative visits. Data will be aggregated as the number and percentage of participants with ureteral stricture within the time frame.	within 90 days
Incidence of secondary intervention or procedure related to UTI or Urine Leak or Ureteral Stricture	Measurement will be the presence or absence of secondary intervention or procedure related to UTI or Urine Leak or Ureteral Stricture. These will be identified through hospital readmissions. Readmission is defined as any unplanned hospital admission during follow-up. Assessments include vitals, adverse event review, labs, urinalysis, and imaging performed at the scheduled post-operative visits. Data will be aggregated as the number and percentage of participants with ureteral stricture within the time frame.	within 12 months after surgery

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Mihir S Shah, MD, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: October 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: colorectal; Urinary Tract Infection; Bladder; UTI; Bladder Cancer; indocyanine green; prostate; Urinary Leak; cystectomy; fluorescence imaging; Muscle-invasive Bladder Cancer; gynecologic; Urologic Oncology; Stent-free Cystectomy; Pelvic Malignancy; ureteral stents; RCIC; ileal conduit urinary diversion
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Urinary Tract Infections; Carcinoma, Transitional Cell; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Optical Imaging
• Other Study ID Numbers: iRISID-2025-0635; JT 45452 (Other Identifier: JeffTrial Number); 2025-117 (Other Identifier: PRMC Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No