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Clinical Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy

RECRUITINGN/ASponsored by Thomas Jefferson University
Actively Recruiting
PhaseN/A
SponsorThomas Jefferson University
Started2025-12-23
Est. completion2028-04-30
Eligibility
Age18 Years – 85 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →

NCT07234968

Summary

Subjects will be randomized into 2 groups (stent or no stent) prior to radical cystectomy with ileal conduit urinary diversion (RCIC). They will follow the standard of care and be enrolled in the study for 12 months post-op. Risk of post-op complications will be analyzed.

Eligibility

Age: 18 Years – 85 YearsHealthy volunteers accepted
Inclusion Criteria:

* Individuals must meet all the following inclusion criteria to be eligible to participate in the study:

  * Provide signed and dated informed consent form
  * Willing to comply with all study procedures and be available for the duration of the study
  * Male or female, age 18 to 85
  * Diagnosed with bladder cancer, other pelvic malignancies necessitating a cystectomy (e.g.: colorectal, prostate, gynecologic) and have elected for a cystectomy with ileal conduit urinary diversion

Exclusion Criteria:

* An individual who meets any of the following criteria will be excluded from participation in this study:

  * Current or history of pelvic radiation
  * Retroperitoneal fibrosis
  * Untreated urinary tract infection (UTI) within 30 days prior to RCIC
  * Pregnancy

Conditions7

Bladder CancerBladder NeoplasmBladder Transitional Cell CarcinomaCancerMuscle-Invasive Bladder CarcinomaPelvic MalignancyUrothelial Carcinoma

Locations2 sites

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Mihir S Shah, MD215-955-6961
Jefferson Einstein Philadelphia Hospital
Philadelphia, Pennsylvania, 19141
Mihir S Shah, MD215-955-6961

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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