Bladder Cancer Requiring CystectomyPhase 3NCT07655284
STENT X: a Randomized Trial to Assess Stent-free Radical Cystectomy
A Phase 3 study testing ureteral stents and no ureteral stent in people with Bladder Cancer Requiring Cystectomy and Ureteral Stents, run by Brigham and Women's Hospital at 2 sites in 2 countries.
Trial summary
Radical Cystectomy (RC) remains the gold standard for localized muscle-invasive bladder cancer (MIBC); however, use of ureteral stents at time of surgery remains controversial without level 1 evidence to comment on risks or benefits of their use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer Requiring Cystectomy, Ureteral Stents
- What is being tested?
- ureteral stents and no ureteral stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2026to 31 Aug 2029
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Brazil1 site
Instituto do Câncer do Estado de São Paulo (ICESP)
São Paulo, São Paulo, 01246-000
About this study
Official title: STENT X Non-stent Genito-urinary Tract Reconstruction After Radical Cystectomy for Bladder Cancer - a Prospective, Randomized, Controlled and Multi Institutional Trial
Radical Cystectomy (RC) remains the gold standard for localized muscle-invasive bladder cancer (MIBC); however, use of ureteral stents at time of surgery remains controversial without level 1 evidence to comment on risks or benefits of their use. RC complications commonly include urinary tract infections (UTIs), pyelonephritis, ureteroileal leakage and stenosis, and can occur with either ileal conduit or orthotopic neobladder diversions. Traditionally, ureteral stents are thought to support anastomotic healing and reduce the risk of anastomotic leakage and strictures; however, emerging evidence from retrospective studies suggests that stent use may paradoxically increase rates of postoperative morbidity. This randomized, multicenter and prospective study aims to compare 30-day postoperative complication rates between stented and non-stented urinary diversions in patients undergoing RC for MIBC, in both ileal conduit or neobladder with either robotic or open approaches.
Read the detailed description
Radical Cystectomy (RC) remains the gold standard for localized muscle-invasive bladder cancer (MIBC); however, use of ureteral stents at time of surgery remains controversial without level 1 evidence to comment on risks or benefits of their use. RC complications commonly include urinary tract infections (UTIs), pyelonephritis, ureteroileal leakage and stenosis, and can occur with either ileal conduit or orthotopic neobladder diversions. Traditionally, ureteral stents are thought to support anastomotic healing and reduce the risk of anastomotic leakage and strictures; however, emerging evidence from retrospective studies suggests that stent use may paradoxically increase rates of postoperative morbidity. This randomized, multicenter and prospective study aims to compare 30-day postoperative complication rates between stented and non-stented urinary diversions in patients undergoing RC for MIBC, in both ileal conduit or neobladder with either robotic or open approaches. Randomization between ureteroenteric anastomosis with or without ureteral stent placement will occur at time of surgery; the surgeon will know this information at time of surgery and the patient will be aware of the placement of stents following surgery as these are externalized and visible. The primary outcome will be complication rate in 30 days after the surgery. Secondary outcomes of this trial will include: length of stay, procedure duration, emergency room visits, patient reported pain, anastomotic leakage rate, ureteral stricture rate, post-operative nephrostomy tube placement, differences in complication rates between interrupted and running suture technique. The study will be conducted across three academic institutions: Brigham and Women's Hospital (BWH), Massachusetts General Hospital (MGH) and Instituto do Câncer do Estado de São Paulo (ICESP), Brazil.
- Being tested
- ureteral stents, no ureteral stent
- Keywords
- bladder cancer, cystectomy, ureteral stents
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ureteral stentsDevice
standard of care single-J externalized ureteral stents to be placed at time of radical cystectomy
no ureteral stentDevice
no ureteral stents used at time of radical cystectomy
| Study group | Role | What they receive |
|---|---|---|
| ureteral stents placed at time of cystectomy | Active comparator | standard of care ureteral stent placement at time of radical cystectomy (control arm) Receives: Device: ureteral stents |
| stent-free, no stent placement at time of cystectomy | Experimental | forgo ureteral stent placement at time of radical cystectomy (intervention arm) Receives: Device: no ureteral stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative readmission rate
percent of patients re-admitted
Measured: 30-days after surgery
Secondary outcomes (8)
length of stay
index hospitalization (days after surgery until discharge, excluding pre-admission if applicable)
Measured: 30 days
procedure duration
surgical time measured from incision to closing
Measured: 30 days
blood transfusion rate
percent of patients requiring blood transfusion
Measured: 30 days
Emergency room visits
percent of patients presenting to emergency room at least once after surgery
Measured: 30 days
patient reported pain on analog scale
analog 0 to 10 scale where 0 is no pain (best) and 10 is excruciating pain (worst)
Measured: 30 days
ureteral stricture rate
percent of patients developing ureteral stricture requiring intervention (e.g. nephrostomy tube placement)
Measured: 30 days
urine leak rate
percent of patients developing urine leak requiring intervention (e.g. interventional radiology procedure)
Measured: 30 days
pyelonephritis rate
percent of patients developing of urinary tract infection (defined by clinical sequelae of infection in setting of positive urinalysis requiring treatment with antibiotics)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Why it stopped: Study withdrawn prior to enrollment. Principle Investigator changed institutions prior to obtaining IRB approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Cancer Requiring CystectomyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Clinton, Brigham and Women's Hospital
- Investigators
- Timothy N Clinton, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655284
- Sponsor's protocol ID
- 2025P002187
- Status last verified
- Aug 2026
- First submitted
- 12 Jun 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: As part of IRB approval of the study decision was for privacy policy that only aggregated data would be intended to be shared outside the institutional system and any IPD would be solely stored on HIPAA compliant servers at the facility. De-identified or aggregated data would be permitted to be shared so long as subjects could not be identified.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STENT X Non-stent Genito-urinary Tract Reconstruction After Radical Cystectomy for Bladder Cancer - a Prospective, Randomized, Controlled and Multi Institutional Trial
- ClinicalTrials.gov ID
- NCT07655284
- Acronym / sponsor ID
- 2025P002187
- Keywords
- bladder cancer, cystectomy, ureteral stents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn prior to enrollment. Principle Investigator changed institutions prior to obtaining IRB approval.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 17 Jun 2026 (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.
Radical Cystectomy (RC) remains the gold standard for localized muscle-invasive bladder cancer (MIBC); however, use of ureteral stents at time of surgery remains controversial without level 1 evidence to comment on risks or benefits of their use. RC complications commonly include urinary tract infections (UTIs), pyelonephritis, ureteroileal leakage and stenosis, and can occur with either ileal conduit or orthotopic neobladder diversions. Traditionally, ureteral stents are thought to support anastomotic healing and reduce the risk of anastomotic leakage and strictures; however, emerging evidence from retrospective studies suggests that stent use may paradoxically increase rates of postoperative morbidity. This randomized, multicenter and prospective study aims to compare 30-day postoperative complication rates between stented and non-stented urinary diversions in patients undergoing RC for MIBC, in both ileal conduit or neobladder with either robotic or open approaches.
Detailed description
Radical Cystectomy (RC) remains the gold standard for localized muscle-invasive bladder cancer (MIBC); however, use of ureteral stents at time of surgery remains controversial without level 1 evidence to comment on risks or benefits of their use. RC complications commonly include urinary tract infections (UTIs), pyelonephritis, ureteroileal leakage and stenosis, and can occur with either ileal conduit or orthotopic neobladder diversions. Traditionally, ureteral stents are thought to support anastomotic healing and reduce the risk of anastomotic leakage and strictures; however, emerging evidence from retrospective studies suggests that stent use may paradoxically increase rates of postoperative morbidity. This randomized, multicenter and prospective study aims to compare 30-day postoperative complication rates between stented and non-stented urinary diversions in patients undergoing RC for MIBC, in both ileal conduit or neobladder with either robotic or open approaches. Randomization between ureteroenteric anastomosis with or without ureteral stent placement will occur at time of surgery; the surgeon will know this information at time of surgery and the patient will be aware of the placement of stents following surgery as these are externalized and visible. The primary outcome will be complication rate in 30 days after the surgery. Secondary outcomes of this trial will include: length of stay, procedure duration, emergency room visits, patient reported pain, anastomotic leakage rate, ureteral stricture rate, post-operative nephrostomy tube placement, differences in complication rates between interrupted and running suture technique. The study will be conducted across three academic institutions: Brigham and Women's Hospital (BWH), Massachusetts General Hospital (MGH) and Instituto do Câncer do Estado de São Paulo (ICESP), Brazil.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ureteral stents placed at time of cystectomy | Active comparator | Device: ureteral stentsstandard of care ureteral stent placement at time of radical cystectomy (control arm) |
| stent-free, no stent placement at time of cystectomy | Experimental | Device: no ureteral stentforgo ureteral stent placement at time of radical cystectomy (intervention arm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 stentsstandard of care single-J externalized ureteral stents to be placed at time of radical cystectomy | Device | ureteral stents placed at time of cystectomy |
| no ureteral stentno ureteral stents used at time of radical cystectomy | Device | stent-free, no stent placement at time of cystectomy |
Primary outcome
Post-operative readmission rate
Time frame: 30-days after surgery
percent of patients re-admitted
8 secondary outcomes
length of stay
Time frame: 30 days
procedure duration
Time frame: 30 days
blood transfusion rate
Time frame: 30 days
Emergency room visits
Time frame: 30 days
patient reported pain on analog scale
Time frame: 30 days
ureteral stricture rate
Time frame: 30 days
urine leak rate
Time frame: 30 days
pyelonephritis rate
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No. As part of IRB approval of the study decision was for privacy policy that only aggregated data would be intended to be shared outside the institutional system and any IPD would be solely stored on HIPAA compliant servers at the facility. De-identified or aggregated data would be permitted to be shared so long as subjects could not be identified.
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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. This study is not recruiting at the moment.
Timothy N Clinton, MD principal investigator
Brigham and Women's Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ureteral stents and no ureteral stent in people with Bladder Cancer Requiring Cystectomy and Ureteral Stents, run by Brigham and Women's Hospital at 2 sites in 2 countries.
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 13 Aug 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, Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative readmission rate (time frame: 30-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 13 Aug 2026.