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

ConditionsBladder Cancer Muscle-Invasive Bladder Carcinoma Urothelial Carcinoma Pelvic Malignancy Bladder Transitional Cell Carcinoma Bladder Neoplasm

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-85

SponsorThomas Jefferson University

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Current or history of pelvic radiation

Retroperitoneal fibrosis

Untreated urinary tract infection (UTI) within 30 days prior to RCIC

Pregnancy

Trial design

Treatments tested in this trial

Ureteral Stent Placement
No Ureteral Stent
Indocyanine Green with Fluorescence Imaging

Treatment groups

70 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Thomas Jefferson University

Lead sponsor

Source ClinicalTrials.gov