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OpenTrials
Completed

NCT Number: NCT04731090

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

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Armed forced Hospital

Mecca, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

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

Other

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

Primary outcomes

  1. Urinary tract infection

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Egyptian Biomedical Research Network

Network

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 29, 2021
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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