Does Antibiotic Prophylaxis at Urinary Catheter Removal Prevent Urinary Tract Infections

Not Applicable

• Conditions: Urologic Diseases; Urinary Tract Disease
• Interventions: Drug: Cefuroxime axetil (trimethoprim/sulfamethoxazole if penicillin allergy)

• Registration Number: NCT05577273
• Lead Sponsor: Omri Schwarztuch Gildor

Brief Summary

At the end of most urological procedures, the doctor inserts a urethral catheter for a period of up to 5 days. According to AUA's guidelines, prophylactic antibiotic is indicated during catheter removal.

The aim of our study is to check the influence of the antibiotic treatment on urinary tract infections after catheter removal

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-14
• Status Verified: 2022-10
• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-09
• Last Update Submitted: 2022-10-09
• Study First Posted: 2022-10-13
• Last Update Posted: 2022-10-13
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• performing urological operation for other reason

Exclusion Criteria

• cannot give informed consent
• <18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotic prophylaxis	Cefuroxime axetil (trimethoprim/sulfamethoxazole if penicillin allergy)	Single dose of p.o. antibiotic given 1 hour before catheter removal. The antibiotic of choice is Cefuroxime axetil 500 mg. For penicillin allergy, trimethoprim/sulfamethoxazole 160mg/800mg.

Primary Outcome Measures

Name	Time	Method
UTI	30 day	Number of participants with primary care/emergency department visits because of dysuria, fever, chills or other UTI related symptoms

Secondary Outcome Measures

Name	Time	Method
Hospitalizations due to UTI	30 day
Bacteremia	30 day	Number of patients admitted to the hospital, that have at least 1 positive blood culture
positive culture approved UTI	30 day	Number of participants with primary care/emergency department visits because of dysuria, fever, chills or other UTI related symptoms, and a positive urine/blood culture taken during the time frame

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar-Sava, Israel