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Using a randomized 2 arm design, this study is being conducted to test for non-inferiority of no prophylactic 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | No prophylactic antibiotics post operatively. Participants will receive antibiotics only if needed post-operatively such as for infection | |
| Treatment group | Experimental | Prophylactic antibiotics postoperatively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylactic antibiotics postoperatively. | Drug | Prophylactic antibiotics postoperatively. All participants in this arm will receive nitrofurantoin 100 milligrams by mouth daily for either 10 or 21 days based on whether they had an ileal conduit or orthotopic neobladder, respectively, for the diversion. Participants will be instructed to swallow the capsule whole, preferably with food and at the same time each day. If a dose is forgotten, participants will be asked to take it when they remember and then take the next dose as usual. However, if they do not remember until the next dose, do not take extra capsules to make up the missed dose. |
| Measure | Description | Time Frame |
|---|---|---|
| test for non-inferiority | 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. | 90 days |
| Difference in risk | 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. | 30 and 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Judith Graziano | Contact | 612-625-7486 | grazi005@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hamed Ahmadi | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55414 | United States |
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Randomized non-inferiority trial.
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