Early vs Late Stent Removal for Bladder Cancer

(STENT-OPT Trial)

Overseen By Kaydee Connors, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Palliative cystectomies, Alternative diversions, Radiotherapy, Upper tract cancer

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal timing for removing stents in patients undergoing bladder cancer surgery. Stents, small tubes that aid urine flow post-surgery, can also lead to infections. The study compares early stent removal (5-7 days after surgery) with later removal (4-6 weeks after surgery) to determine which approach results in fewer complications. Patients who undergo bladder cancer surgery with a specific type of urinary reconstruction (ileal conduit) may be suitable for this trial. As an unphased trial, it provides patients the chance to contribute to significant research that could enhance post-surgical care and outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this stent removal protocol is safe?

Studies have shown that early removal of stents after bladder surgery can be safer for patients. Research indicates that removing the stent around 5 days post-surgery results in fewer urinary tract infections (UTIs) and reduces the likelihood of hospital readmission within 90 days. This leads to fewer complications for those who have the stent removed early.

In contrast, keeping the stent in for 4-6 weeks has been linked to more hospital visits, suggesting that delaying stent removal may increase risks.

Overall, early stent removal appears to be easier on patients and results in fewer issues compared to extended stent retention. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these stent removal techniques for bladder cancer because they aim to optimize the timing of stent removal, potentially improving patient outcomes. Unlike the standard approach where stent removal timing isn't precisely defined, this investigation compares early versus late removal, offering insights into which timing reduces complications and enhances recovery. By refining the removal schedule, these methods could lead to less discomfort, faster recovery, and better overall patient experiences.

What evidence suggests that this trial's treatments could be effective for bladder cancer?

This trial will compare early stent removal with late stent removal after bladder removal surgery. Research has shown that early stent removal can lead to fewer urinary tract infections and reduce the likelihood of hospital readmissions. One study found that removing the stent around 8 days after surgery did not increase the risk of urine leaks or infections compared to later removal. Waiting longer, typically 4 to 6 weeks, to remove the stent has been linked to a higher chance of narrowings at the surgical connection points. Overall, early stent removal appears to result in fewer complications and better outcomes regarding infections and hospital visits. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone radical cystectomy and ileal conduit formation due to bladder cancer. It's designed to see if removing stents early (5-7 days) or late (4-6 weeks) after surgery is better. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards.

Inclusion Criteria

Able to give informed written consent to participate

I am an adult with bladder cancer scheduled for major bladder surgery.

Exclusion Criteria

I am undergoing or have undergone a specific type of urinary tract surgery.

I have had radiotherapy in my abdomen or pelvis before.

My treatment is not aimed at curing my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo radical cystectomy and ileal conduit formation with either early stent removal (5-7 days) or late stent removal (4-6 weeks)

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of uretero-enteric anastomosis complications

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Early Stent removal
• Late Stent removal

Trial Overview The study tests the timing of stent removal following bladder cancer surgery with an ileal conduit urinary diversion. Participants will be randomly assigned to have their stents removed either early or late post-operation, aiming to determine which method leads to fewer complications like infections or strictures.

How Is the Trial Designed?

Group I: Arm A Experimental Treatment 1 Intervention

Early Stent removal

Group II: Arm B Active Control 1 Intervention

Late Stent removal

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2405456925001543

Bladder Cancer A Systematic Review and Meta-analysis ... Early stent removal (5 d) was associated with reduced urinary tract infections and hospital readmission (n = 1). There was a high/serious risk ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06595446

Study Details | NCT06595446 | A Feasibility Randomized ... The progression rate of NMIBC to Muscle-invasive bladder cancer (MIBC) varies between 5-50% at 5 years dependent on histopathological features such as grade, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11833543/

Comparative outcomes of internal, external, and no stent in ... Internal stents reduce early postoperative complications, including hydronephrosis and renal dysfunction, while lowering the risk of late UIAS.

4. urologytimes.com urologytimes.com/view/early-stent-removal-following-radical-cystectomy-does-not-increase-risk-of-uti-urine-leak

Early stent removal following radical cystectomy does not ... The average day of stent removal for the patients with early removal was 8.0, compared with 19.9 for patients in the late removal cohort.

5. urotoday.com urotoday.com/conference-highlights/cua-2017/114459-post-ureteral-stent-removal-symptoms.html

Post Ureteral Stent Removal Symptoms Radical cystectomy is an effective treatment option for high-risk, non-muscle-invasive bladder cancer (NMIBC) to prevent progression. A recent 12-year ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32303901/

Safety of decreasing ureteral stent duration following ... The duration of stenting decreased significantly from approximately 15.5-5 days (P < 0.001). The LSR had higher 90-day overall readmission rates (OR = 2.57, 95% ...

7. auajournals.org auajournals.org/doi/10.1097/JU.0000000000004387

Perioperative Complications and Omission of Ureteral ... Some early studies found a decreased rate of urine leaks when using ureteral stents, while others found no significant difference in ...

8. urotoday.com urotoday.com/center-of-excellence/mcrpc-treatment/from-the-editor/114459-post-ureteral-stent-removal-symptoms.html

Post Ureteral Stent Removal Symptoms What we found out was that 64% had symptoms after the stent was removed, and they were mostly: ... ...but they also included: ... All the symptoms ...