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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04731090

Enrollment

100

Registered

2021-01-29

Start date

2018-08-01

Completion date

2020-09-30

Last updated

2021-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infections

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.

Interventions

DRUGIV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively.

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

OTHERUrine 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026