NCT07655284WithdrawnPhase 3
STENT X: a Randomized Trial to Assess Stent-free Radical Cystectomy
STENT X Non-stent Genito-urinary Tract Reconstruction After Radical Cystectomy for Bladder Cancer - a Prospective, Randomized, Controlled and Multi Institutional Trial
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Reason given: Study withdrawn prior to enrollment. Principle Investigator changed institutions prior to obtaining IRB approval.
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 12 Jun 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Bladder cancer
- NCT number
- NCT07655284
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Simultaneous surgical procedures (except those specified in the inclusion criteria that are considered part of a routine radical cystectomy)
- History of prior urinary diversion
- Previous radiation therapy in the pelvis for any reason
Other illness
- Cystectomy for other reasons than Bladder cancer
Other
- Patients who decline to participate, lack understanding of the study's purpose, or are unable to provide informed consent
- Extremely debilitated patients, malnourished individuals, or those undergoing palliative or hygienic cystectomy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | Brazil | Unknown status |
| Brigham and Women's Hospital | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.