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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "They will follow the standard of care and be enrolled in the study for 12 months post-op."
  • "Subjects will be enrolled in this study for 12 months."
  • "Patient will be followed for 12 months post treatment or until their death."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares using a ureteral stent (a small tube that helps urine drain from the kidney) with using no stent during bladder removal surgery. It is for adults with cancer who choose bladder removal and a new path for urine made from a piece of bowel. A chance process assigns each person to a group, and the study tracks problems after surgery for 12 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign and date a form agreeing to join the study.
  • Be willing to follow all study steps and take part for the full 12 months after surgery.
  • Be 18 to 85 years old.
  • Have bladder cancer or another cancer in the lower belly area that requires bladder removal, and choose surgery that uses a piece of bowel to make a new path for urine.

Who can't join

  • Have had or are now getting radiation treatment to the lower belly area.
  • Have retroperitoneal fibrosis, a buildup of scar tissue deep in the belly.
  • Have an untreated urinary tract infection within 30 days before surgery.
  • Be pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (2)

PA