Administration of Antibiotic Prophylaxis for Transperineal Prostate Biopsy in Cipto Mangunkusumo Hospital

• Status: Recruiting
• Trial end date: 2023-07-06
• Target enrollment: 0
• Participant gender: Male

Summary

This randomized controlled trial aims to compare the rate of perioperative infection complications in transperineal prostate biopsy between the group that receives prophylactic antibiotic and the group that receives placebo. The types of infection studied included bacteriuria, urinary tract infection (UTI), UTI with fever (febrile UTI), and sepsis. This study hypothesized that the administration of prophylactic antibiotics during transperineal prostate biopsy would result in lower rates of perioperative infection complications.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indonesia University
• Treatments: Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

Inclusion Criteria:

• Patient with lower urinary tract symptoms aged >45 years with either PSA levels of 4.0 ng/mL or higher or abnormal findings on digital rectal examination (DRE)

• Patient with a negative initial urine culture / urinalysis test

Exclusion Criteria:

• Patients who refuses to undergo transperineal prostate biopsy

• Patients who refuses to participate in the research

• Patient who is unable to communicate effectively

• Patient with a documented history of cotrimoxazole allergy

• Patient who has consumed antibiotics for other indications prior to undergoing prostate biopsy

• Patient with urinary tract infection symptoms prior to undergoing prostate biopsy

• Patient with a history of immunodeficiency disorders or long-term corticosteroid use

• Patient with a history of prostate cancer

• Patient with a history of prior prostate biopsy