Standard Antibiotic Versus Enhanced Prophylactic Measures on Rate of Urinary Tract Infection After Flexible Ureteroscopy

Study Overview
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Brief Summary
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Background and aim: Urinary tract infections (UTIs) are commonly seen after flexible ureteroscopy. Prevention of UTIs remains controversial. The present randomized study aimed to compare the rate of post-procedural UTI in patients subjected to the standard antibiotic prophylaxis alone versus enhanced prophylactic measures. Patients and methods: The study included 100 patients subjected to fURS for management of ureteral and/or renal stones. Patients were equally and randomly allocated into one of the two treatment groups using randomly computer-generated allocation tables and concealed envelope technique. Treatment groups included standard antibiotic prophylaxis group and enhanced prophylaxis group. Patients in the standard antibiotic prophylaxis group IV fluoroquinolone 1 hour preoperatively and oral antibiotics were used for 24h postoperatively. In the enhanced prophylaxis group, patients had urine culture 10 days before the procedure. In addition to the antibiotic prophylaxis, hydrophilic-coated ureteral access sheaths were systematically used.

Official Title
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Effect of Standard Antibiotic Prophylaxis Versus Enhanced Prophylactic Measures on Rate of Urinary Tract Infection After Flexible Ureteroscopy

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Drug: IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively.
* Other: Urine culture, antibiotic prophylaxis and hydrophilic-coated ureteral access sheaths


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients subjected to flexible ureteroscopy for management of ureteral and/or renal stones. Exclusion Criteria: Symptomatic urinary tract infection. Use of rigid ureteroscopy and antegrade ureteroscopy.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard antibiotic prophylaxis<br>IV fluoroquinolone 1 hour preoperatively and oral antibiotics were used for 24h postoperatively. | Drug: IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively.<br>* IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively.<br>|
| Experimental: enhanced prophylaxis<br>Patients had urine culture 10 days before the procedure. In addition to the antibiotic prophylaxis, hydrophilic-coated ureteral access sheaths were systematically used. | Other: Urine culture, antibiotic prophylaxis and hydrophilic-coated ureteral access sheaths<br>* Patients had urine culture 10 days before the procedure. In addition to the antibiotic prophylaxis, hydrophilic-coated ureteral access sheaths were systematically used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary tract infection | Postoperative UTI was defined as the occurrence of a temperature higher than 38 °C associated with pyuria and/or bacteriuria without any other focal infectious sites. | 30-day postoperative |