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

NCT04731090 | Completed

• 1 other identifier: N2113
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• Urinary tract infection

  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.

  30-day postoperative

Study Arms (2)

Standard antibiotic prophylaxis

ACTIVE COMPARATOR

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.

enhanced prophylaxis

EXPERIMENTAL

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

Interventions

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

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

Standard antibiotic prophylaxis

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.

enhanced prophylaxis

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients subjected to flexible ureteroscopy for management of ureteral and/or renal stones.

You may not qualify if:

• Symptomatic urinary tract infection.
• Use of rigid ureteroscopy and antegrade ureteroscopy.

Sponsors & Collaborators

• Egyptian Biomedical Research Network: lead

Study Sites (1)

Armed forced Hospital

Mecca, Saudi Arabia

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Fluoroquinolones; Anti-Bacterial Agents; Antibiotic Prophylaxis

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Chemoprevention; Drug Therapy; Therapeutics; Premedication

Study Officials

• Mohamed Elhelaly

  Al-Azhar Universiy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 29, 2021
• Study Start: August 1, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)