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

Not Applicable

Completed

• Conditions: Urinary Tract Infections
• Interventions: Drug: IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively.; Other: Urine culture, antibiotic prophylaxis and hydrophilic-coated ureteral access sheaths

• Registration Number: NCT04731090
• Lead Sponsor: Egyptian Biomedical Research Network

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2021-01
• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-01-28
• Last Update Submitted: 2021-01-28
• Study First Posted: 2021-01-29
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard antibiotic prophylaxis	IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively.	IV fluoroquinolone 1 hour preoperatively and oral antibiotics were used for 24h postoperatively.
enhanced prophylaxis	Urine culture, antibiotic prophylaxis and hydrophilic-coated ureteral access sheaths	Patients had urine culture 10 days before the procedure. In addition to the antibiotic prophylaxis, hydrophilic-coated ureteral access sheaths were systematically used.

Primary Outcome Measures

Name	Time	Method
Urinary tract infection	30-day postoperative	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.

Trial Locations

Locations (1)

Armed forced Hospital; 🇸🇦 Mecca, Saudi Arabia