Prophylactic Antibiotics After Bladder Cancer Surgery
This study is looking at whether taking prophylactic antibiotics (preventative antibiotics) after surgery for muscle-invasive bladder cancer (cancer that has spread into the bladder muscle) is better than not taking them. Specifically, it's comparing no antibiotics to a drug called nitrofurantoin, given daily for 10 or 21 days depending on your type of urinary diversion (how urine leaves your body after bladder removal). The main goal is to see if not taking antibiotics is just as good as taking them at preventing urinary tract infections (UTIs) in the 90 days after surgery. You may be able to join if you are 18 or older, have muscle-invasive bladder cancer, and are having your bladder removed with either an ileal conduit or neobladder diversion. The study plans to enroll 120 participants.
- Study design
- This is a randomized study with two groups, meaning participants are randomly assigned to either receive nitrofurantoin or no prophylactic antibiotics. It plans to enroll 120 participants.
- What's involved
- Participants will receive nitrofurantoin daily for 10 or 21 days after surgery, depending on their type of urinary diversion. The study will compare rates of postoperative urinary tract infections.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will follow participants for 90 days after surgery to measure the difference in risk of urinary tract infections.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Prophylactic Antibiotics in Cystectomy With Diversion
At a glance
Conditions
NCT06190197
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Minnesota
Minneapolis, Minnesotastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Hamed Ahmadi · PRINCIPAL_INVESTIGATOR · University of Minnesota
Who to contact
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Inclusion
Exclusion
What this trial measures
- test for non-inferiority90 days
Test for non-inferiority of no antibiotic therapy versus the prophylactic oral antibiotic, nitrofurantoin, through comparison of rates of postoperative urinary tract infections within the 90-day postoperative period in patients with muscle invasive bladder cancer who undergo radical cystectomy with urinary diversion.
- Difference in risk30 and 90 days
Difference in risk of UTI within the first 30 days postoperative between treatment and no treatment groups. 2-sample, 2-sided, t-test for a difference in proportions. Statistical hypothesis: H0: R1 - R2 = 0, Hα: R1 - R2 ≠ 0, where R1 is the risk (proportion) of UTI infection within the first 30 days, post operation, among those in the treatment group, and R2 among placebo.