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Bladder cancer surgery: do stents help or hurt?

NCT ID NCT07655284

Disease control Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This study looks at whether using ureteral stents (small tubes) after bladder cancer surgery leads to more or fewer problems than not using them. About 190 adults having their bladder removed will be randomly assigned to get stents or not. The main goal is to see who ends up back in the hospital within 30 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ureteral stents (device)
What this could lead to
If this trial succeeds, it could show that skipping stents reduces complications and hospital readmissions after bladder cancer surgery.
What could go wrong
This is a Phase 3 trial, but results may vary by patient and surgical technique. Stents have been standard for years, so not using them could increase leakage or stricture risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults (\> 18 years old) * Muscle invasive bladder cancer or non-muscle invasive bladder cancer with indication of Radical Cystectomy * No concomitant surgeries like nephrectomies, colectomies or removal of other organs affected by the tumor (Except standard lymph node dissections as well as in men the prostate and seminal vesicles and in women the uterus, fallopian tubes, ovaries and vagina, that are considered part of the oncological radical cystectomy.) * Patients who have the capacity to understand the study procedures and provide written informed consent Exclusion Criteria: * Simultaneous surgical procedures (except those specified in the inclusion criteria that are considered part of a routine radical cystectomy) * History of prior urinary diversion * Patients who decline to participate, lack understanding of the study's purpose, or are unable to provide informed consent * Cystectomy for other reasons than Bladder cancer * Previous radiation therapy in the pelvis for any reason * Extremely debilitated patients, malnourished individuals, or those undergoing palliative or hygienic cystectomy

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Conditions

The condition(s) this trial relates to.

infiltrating bladder urothelial carcinoma non-invasive bladder urothelial carcinoma superficial urinary bladder carcinoma urinary bladder cancer urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder cancer requiring cystectomy Ureteral stents

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Instituto do Câncer do Estado de São Paulo (ICESP)

    São Paulo, São Paulo, 01246-000, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.