An observational study in Ureteral Obstruction, Neoplasms and Acute Kidney Injury, sponsored by Barretos Cancer Hospital. Completed at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Barretos Cancer Hospital · Observational
This study aims to find out whether taking antibiotics to prevent a urinary tract infection after a medical procedure called percutaneous nephrostomy (placement of a catheter directly into the kidney to keep it working after the urinary tract has been blocked by a malignant tumour) actually prevents a urinary tract infection, compared to not taking antibiotic prophylaxis.
The medical records of cancer patients who underwent percutaneous nephrostomy between January 2013 and July 2020 were reviewed. Procedures were excluded if the nephrostomy was used for other procedures (e.g. double-J passage) or for non-malignant urinary tract obstruction (e.g. kidney stones). The association between antibiotic prophylaxis and UTI was assessed using association tests such as Pearson's chi-squared or Fisher's exact test. A significant level of 5% was adopted.
Definitions:
Urinary tract infection - occurs when there are signs and symptoms consistent with a local infection (fever, chills, dysuria, lower back pain, and costovertebral angle tenderness), such as cystitis (bladder or lower UTI) or pyelonephritis (kidney or upper UTI), combined with a positive urine culture (more than 104 colony-forming units of microorganisms per millilitre of urine with a catheter present or more than 105 colony-forming units of microorganisms per millilitre of urine without a catheter present).
UTI related to percutaneous nephrostomy procedure - occurs until seven days after the percutaneous nephrostomy procedure, both for first placement and/or catheter replacement.
UTI related to the nephrostomy catheter - occurs at another time, usually within 90 days of the procedure, in the presence of the nephrostomy catheter, and in the absence of another focus that would justify the infection.
Antibiotic prophylaxis was administered before percutaneous nephrostomy. If there was no record of antibiotics in the cost centre of the institution's database, it was considered that antibiotic prophylaxis was not given.
For the first percutaneous nephrostomy catheter placement, antibiotic prophylaxis was given empirically.
For catheter replacement, antibiotic prophylaxis was both empirical and targeted, based on the result of a pre-procedure urine culture to guide the antibiotic choice.
Percutaneous nephrostomies (first placement and/or catheter replacement) were excluded from analysis if patients were treated for UTI up to 7 days before or during the procedure. However, they were included in analysis outside the period of antibiotic prophylaxis for future UTIs.
33 studies on the registry are indexed under Ureteral Obstruction; 5 are open to participants now.
Browse Ureteral Obstruction studies →Barretos Cancer Hospital is the lead sponsor of 49 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated for cancer who required percutaneous nephrostomies
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
No antibiotic prophylaxis before percutaneous nephrostomy
With antibiotic prophylaxis before percutaneous nephrostomy
Drug: antibiotic prophylaxis
Antibiotic prophylaxis before percutaneous nephrostomy
Urinary Tract Infection After Percutaneous Nephrostomy Procedure
Proportion of urinary tract infection after each percutaneous nephrostomy
Time frame: Up to 7 days after percutaneous nephrostomy
Data were collected on age, sex, skin colour, number of percutaneous nephrostomies performed, including first placements and catheter replacements. The time spent ill and using the nephrostomy catheter was calculated.
| Milestone | No Antibiotic Prophylaxis (NAP) - Group | Antibiotic Prophylaxis (AP) - Group |
|---|---|---|
| Started | 66 | 153 |
| Completed | 66 | 153 |
| Not completed | 0 | 0 |
Proportion of urinary tract infection after each percutaneous nephrostomy
| Percutaneous nephrostomy procedure | No Antibiotic Prophylaxis (NAP) - Group | Antibiotic Prophylaxis (AP) - Group |
|---|---|---|
| Urinary Tract Infection After Percutaneous Nephrostomy Procedure | 5 | 10 |
Collected over From enrollment until end of follow-up, an average of 1 week.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Antibiotic Prophylaxis (NAP) - Group | 53/66 (80.3%) | 0/66 (0%) | 0/66 (0%) |
| Antibiotic Prophylaxis (AP) - Group | 127/153 (83%) | 0/153 (0%) | 0/153 (0%) |
The use of antibiotic prophylaxis is generally recommended by institutional protocol.
| Age, Continuous(year-old) | No Antibiotic Prophylaxis (NAP) - Group | Antibiotic Prophylaxis (AP) - Group | Total |
|---|---|---|---|
| Median | 54.37 (42.22 to 64.73) | 60.27 (49.45 to 70.19) | 59.04 (45.51 to 68.79) |
| Sex: Female, Male(Participants) | No Antibiotic Prophylaxis (NAP) - Group | Antibiotic Prophylaxis (AP) - Group | Total |
|---|---|---|---|
| Female | 46 | 87 | 133 |
| Male | 20 | 66 | 86 |
| Ethnicity (NIH/OMB)(Participants) | No Antibiotic Prophylaxis (NAP) - Group | Antibiotic Prophylaxis (AP) - Group | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 42 | 103 | 145 |
| Unknown or Not Reported | 24 | 50 | 74 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Publication in a peer-reviewed journal and release of data upon plausible justification
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: For an indefinite period
Access criteria: Justification sent by e-mail
Ran from Apr 2021 to primary completion in Oct 2024, 42 months.
Results were first posted in May 2026, 1 year 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Barretos Cancer Hospital