Ureteral Stents for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effects of using ureteral stents (small tubes to keep urine flowing) during surgery for muscle-invasive bladder cancer. The researchers aim to determine if these stents reduce post-surgery complications, such as infections or leaks. Participants will either receive a stent during surgery or not, to assess which approach is more effective. This trial may suit individuals undergoing bladder cancer surgery without other organ removal, who can understand and consent to the study. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.
What prior data suggests that ureteral stents are safe for bladder cancer surgery?
Research has shown that skipping ureteral stents during surgery might be safe. One study found no major differences in complications within 30 days between patients with stents and those without. Another study suggested that omitting stents after certain surgeries did not lead to more problems. These findings indicate that avoiding stents could be a safe option.
Despite this, ureteral stents are commonly used in surgeries to aid healing. Some studies indicate that stents might actually increase the risk of complications, such as infections. While stents are often used to prevent leaks and blockages, their necessity is under scrutiny. Prospective trial participants should consider these points.12345Why are researchers excited about this trial?
Researchers are excited about the trial exploring the use of ureteral stents in bladder cancer surgery because it challenges the current standard of care. Typically, ureteral stents are placed during a radical cystectomy to help urine pass from the kidneys to the bladder. However, this trial is investigating whether skipping the stent placement could be just as effective or even more beneficial. The key difference here is the potential to reduce complications and discomfort associated with stents, such as pain, infection, or the need for additional procedures. By exploring a stent-free approach, this trial could lead to a less invasive option for patients undergoing bladder cancer surgery.
What evidence suggests that this trial's treatments could be effective for bladder cancer?
This trial will compare the outcomes of using ureteral stents versus not using them during bladder cancer surgery. Research has shown that not using ureteral stents might reduce the risk of complications. One study found that patients without stents experienced fewer problems, such as urinary infections and blockages, compared to those with stents. Another study indicated that using ureteral stents could increase the risk of developing other urinary tract cancers later on. Additionally, evidence suggests that avoiding stents does not raise the risk of urine leaks after surgery. Overall, not using stents might lead to a smoother recovery and fewer issues post-surgery.12345
Who Is on the Research Team?
Timothy N Clinton, MD
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
This trial is for adults with muscle-invasive or certain non-muscle invasive bladder cancer who need their bladder removed (radical cystectomy). Participants must be able to understand and consent, and can't have had prior pelvic radiation, previous urinary diversion, or major additional surgeries at the same time.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo radical cystectomy with randomization to stented or non-stented urinary diversion
Post-operative Monitoring
Participants are monitored for 30-day postoperative complications including infection, leakage, and stricture rates
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- No Ureteral Stent
- Ureteral Stents
Trial Overview
The study compares two approaches during bladder removal surgery: using ureteral stents versus not using them. Patients are randomly assigned to either group to see which method leads to fewer complications within 30 days after surgery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
forgo ureteral stent placement at time of radical cystectomy (intervention arm)
standard of care ureteral stent placement at time of radical cystectomy (control arm)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Citations
Clinical Trial to Evaluate Post-Operative Outcomes of ...
The Principal Investigator hypothesizes that patients with no ureteral stent placement during RCIC will not be associated with a higher risk of post-op ...
Does Ureteral Stenting Increase the Risk of Metachronous ...
Patients treated with ureteral stents had a higher likelihood of metachronous upper tract urothelial carcinoma compared to no stents (OR: 3.49, ...
Stents for malignant ureteral obstruction - PMC - NIH
They had 28% failure rate, Their success rate of insertion was 86.9% of which 91.2% achieved patency of the urinary system. Overall, success rate of this ...
A Feasibility Randomized Trial Evaluating Early vs Late ...
Their review did not provide evidence that these stents were more effective than not using stents in preventing post-diversion urinary leakage.
Bladder Cancer A Systematic Review and Meta-analysis ...
Although there was some evidence of reduced postoperative complications (urinary leak, ureteroileal stricture, postoperative obstruction, length of stay, and ...
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