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

Sponsor

Egyptian Biomedical Research Network (Other)

Overall Status

Completed

CT.gov ID

NCT04731090

Collaborator

(none)

100

Enrollment

Location

Arms

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infections	Drug: IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively. Other: Urine culture, antibiotic prophylaxis and hydrophilic-coated ureteral access sheaths	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 1, 2018

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Sep 30, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Standard antibiotic prophylaxis

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.

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

Experimental: enhanced prophylaxis

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Armed forced Hospital	Mecca		Saudi Arabia

Sponsors and Collaborators

Egyptian Biomedical Research Network

Investigators

Principal Investigator: Mohamed Elhelaly, Al-Azhar Universiy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Egyptian Biomedical Research Network

ClinicalTrials.gov Identifier:

NCT04731090

Other Study ID Numbers:

N2113

First Posted:

Jan 29, 2021

Last Update Posted:

Jan 29, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Communicable Diseases

Urinary Tract Infections

Anti-Bacterial Agents

Fluoroquinolones

Antibiotics, Antitubercular

Study Results

No Results Posted as of Jan 29, 2021