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

Egyptian Biomedical Research Network

Status: Completed

Conditions: Urinary Tract Infections

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

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04731090

N2113

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Standard antibiotic prophylaxis

Active Comparator group

Description:

IV fluoroquinolone 1 hour preoperatively and oral antibiotics were used for 24h postoperatively.

Treatment:

Drug: IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively.

enhanced prophylaxis

Experimental group

Description:

Patients had urine culture 10 days before the procedure. In addition to the antibiotic prophylaxis, hydrophilic-coated ureteral access sheaths were systematically used.

Treatment:

Other: Urine culture, antibiotic prophylaxis and hydrophilic-coated ureteral access sheaths