Bladder CancerNCT07234968
Clinical Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy
A study testing Ureteral Stent Placement, No Ureteral Stent and Indocyanine Green with Fluorescence Imaging in people with Bladder Cancer and Muscle-Invasive Bladder Carcinoma, run by Thomas Jefferson University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bladder Cancer, Muscle-Invasive Bladder Carcinoma, Urothelial Carcinoma
- What is being tested?
- Ureteral Stent Placement, No Ureteral Stent and Indocyanine Green with Fluorescence Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Dec 2025to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Mihir S Shah, MD, 215-955-6961
- Not yet recruiting
Jefferson Einstein Philadelphia Hospital
Philadelphia, Pennsylvania, 19141
Mihir S Shah, MD, 215-955-6961
About this study
Official title: 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.
Read the 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.
- Conditions
- Bladder Cancer, Muscle-Invasive Bladder Carcinoma, Urothelial Carcinoma, Pelvic Malignancy, Bladder Transitional Cell Carcinoma, Bladder Neoplasm
- Being tested
- Ureteral Stent Placement, No Ureteral Stent, Indocyanine Green with Fluorescence Imaging
- 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
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteral Stent PlacementProcedure or surgery
Also called double J, single J, ureteral stents
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 StentProcedure or surgery
Radical cystectomy with ileal conduit urinary diversion (RCIC) performed without ureteral stent placement.
Indocyanine Green with Fluorescence ImagingDiagnostic test
Also called ICG
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Ureteral Stent | Experimental | 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. Receives: Procedure: Ureteral Stent Placement; Diagnostic Test: Indocyanine Green with Fluorescence Imaging |
| Arm 2: No Ureteral Stent | Active comparator | 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. Receives: Procedure: No Ureteral Stent; Diagnostic Test: Indocyanine Green with Fluorescence Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days after surgery
Secondary outcomes (2)
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.
Measured: 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.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start23 Dec 2025
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized 1:1 to receive stent or no stent during RCIC. 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mihir S Shah, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234968
- Sponsor's protocol ID
- iRISID-2025-0635
- Other IDs
- JT 45452, 2025-117
- Status last verified
- Feb 2026
- First submitted
- 14 Oct 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy
- ClinicalTrials.gov ID
- NCT07234968
- Acronym / sponsor ID
- iRISID-2025-0635
- Conditions
- Bladder Cancer, Muscle-Invasive Bladder Carcinoma, Urothelial Carcinoma, Pelvic Malignancy, Bladder Transitional Cell Carcinoma, Bladder Neoplasm
- Keywords
- Bladder, Stent-free Cystectomy, Urinary Tract Infection, Urinary Leak, UTI, Pelvic Malignancy, Bladder Cancer, Urologic Oncology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1 to receive stent or no stent during RCIC. 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Ureteral Stent | Experimental | Procedure: Ureteral Stent Placement, Diagnostic Test: Indocyanine Green with Fluorescence ImagingSubjects 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. |
| Arm 2: No Ureteral Stent | Active comparator | Procedure: No Ureteral Stent, Diagnostic Test: Indocyanine Green with Fluorescence ImagingSubjects 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals must meet all the following inclusion criteria to be eligible to participate in the study:
Key exclusion criteria (5 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ureteral Stent PlacementAlso: double J, single J, ureteral stentsPlacement 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. | Procedure or surgery | Arm 1: Ureteral Stent |
| No Ureteral StentRadical cystectomy with ileal conduit urinary diversion (RCIC) performed without ureteral stent placement. | Procedure or surgery | Arm 2: No Ureteral Stent |
| Indocyanine Green with Fluorescence ImagingAlso: ICGIndocyanine 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. | Diagnostic test | Arm 1: Ureteral Stent, Arm 2: No Ureteral Stent |
Primary outcome
Number of urinary tract infection (UTI)
Time frame: 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.
2 secondary outcomes
Incidence of urinary leak
Time frame: 90 days after surgery
Incidence of ureteral stricture
Time frame: 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mihir S Shah, MD principal investigator
Thomas Jefferson University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ureteral Stent Placement, No Ureteral Stent and Indocyanine Green with Fluorescence Imaging in people with Bladder Cancer and Muscle-Invasive Bladder Carcinoma, run by Thomas Jefferson University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mihir S Shah, MD (215-955-6961, Mihir.Shah@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of urinary tract infection (UTI) (time frame: 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.