Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic for UTI Prevention

University of Indonesia (UI)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Urinary Tract Infections; Urological System Complication of Procedure

Treatments: Drug: Levofloxacin 500mg; Drug: Fosfomycin 3000 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06017479

22-11-1343

Details and patient eligibility

About

The goal of this clinical trial is to compare the use of single dose fosfomycin and single dose levofloxacin as pre-urodynamic antibiotic prophylaxis for urinary tract infection prevention post-urodynamic in patients with lower urinary tract symptoms. The main question[s] it aims to answer are:

• What is the difference between the effectiveness of administering a single dose of fosfomycin and levofloxacin prior to the procedure in terms of the incidence rate of urinary tract infection (UTI) post-urodynamic examination?
• What is the incidence rate of UTI in the administration of single-dose fosfomycin and levofloxacin prior to the procedure on the incidence rate of UTI post-urodynamic examination? Participants fulfilling the inclusion criteria will be taken their history and vital signs and consume either fosfomycin or levofloxacin based on the randomisation prior to urodynamic procedure. Afterwards, participants will undergo urine analysis 4 days post urodynamic to evaluate if there's any urinary tract infection. If there is any bacteria present, the sample will be cultured to identify bacteria found in the urine.

Full description

This study employs a single-blinded randomized clinical trial design to compare the proportion of UTI post-urodynamic examination between the group receiving single-dose levofloxacin pre-urodynamic examination and the group receiving levofloxacin post-urodynamic examination for three days. The target population consists of patients undergoing urodynamic examination at Dr. Cipto Mangunkusumo National Referral Hospital, Persahabatan National Hospital, and Siloam Asri Hospital. The total sample size required for this study is 126 patients. On the fourth day post-urodynamic examination, urinalysis and urine culture are performed to determine the diagnosis of UTI. To analyze the association between UTI and therapy groups, a chi-square test is used. Results are considered statistically significant if p < 0.05.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male/female patients > 18 years who have indications for urodynamics
• Willing to participate in research

Exclusion criteria

• Allergy to levofloxacin
• Allergy to fosfomycin
• History of taking antibiotics in 1 month
• Pregnant
• Uncontrolled DM
• Use of urinary catheter
• Having a UTI before urodynamics, based on clinical symptoms and urine examination results
• Refuse to participate in research

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 2 patient groups

Pre-urodynamic Fosfomycin

Experimental group

Description:

Fosfomycin 3 g single dosage 1 hour before the urodynamic examination

Treatment:

Drug: Fosfomycin 3000 MG

Pre-urodynamic Levofloxacin

Experimental group

Description:

Levofloxacin 500 miligrams single dosage 1 hour before the urodynamic examination

Treatment:

Drug: Levofloxacin 500mg