Prevalence of Bacteriuria, Antibiotic Susceptibility, and Treatment Response in Symptomatic Benign Prostatic Hyperplasia

Completed

• Conditions: Treatment Response to Antibiotics in Symptomatic Benign Prostate Hyperplasia; Bacteriuria in Symptomatic Benign Prostate Hyperplasia; Antibiotic Susceptibility in Symptomatic Benign Prostate Hyperplasia
• Interventions: Drug: Antibiotic therapy

• Registration Number: NCT06520267
• Lead Sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.

Brief Summary

The goal of this prospective observational study is to identify the common pathogens and antibiotic sensitivity pattern in urine samples of men with symptomatic BPH and to assess severity of LUTS in patients with symptomatic BPH using IPSS score before and after antibiotic therapy.

Detailed Description

This was a hospital-based prospective observational study.

All patients with symptomatic BPH attending the Urology Out-Patient Department (OPD) of the study site were enrolled. Informed and written consent was obtained from all participants. Demographic data were recorded, and detailed histories were taken regarding the duration and symptoms of BPH, including incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining, nocturia, and relevant past history. IPSS scoring was conducted. A thorough clinical examination, including general physical, systemic, and digital rectal examination, was performed. During the rectal examination, the prostate was checked for nodules, softness, induration, or tenderness. Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile.

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2021-06-12
• Study Completion: 2021-08-15
• Status Verified: 2024-07
• Study First Submitted: 2024-07-21
• Study First Submitted QC: 2024-07-21
• Last Update Submitted: 2024-07-21
• Study First Posted: 2024-07-25
• Last Update Posted: 2024-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 131

Inclusion Criteria

• Patients with symptomatic BPH.

Exclusion Criteria

• Patients with indwelling catheters
• Recent antibiotic use
• Immunocompromised states (e.g., HIV, HCV)
• Uncontrolled diabetes mellitus (Hemoglobin A1c > 7%)
• Steroid therapy
• Those who declined to provide consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
symptomatic BPH	Antibiotic therapy	All patients with symptomatic BPH attending the Urology Out-Patient Department (OPD) of the study site were enrolled. Informed and written consent was obtained from all participants. Demographic data were recorded, and detailed histories were taken regarding the duration and symptoms of BPH and relevant past history. IPSS scoring was conducted. A thorough clinical examination, including general physical, systemic, and digital rectal examination, was performed. During the rectal examination, the prostate was checked for nodules, softness, induration, or tenderness. Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile.

Primary Outcome Measures

Name	Time	Method
Identification of common pathogens and Antibiotic susceptibility testing	4 weeks	Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile among symptomatic patients with BPH.

Secondary Outcome Measures

Name	Time	Method
Severity of LUTS in patients with symptomatic BPH	4 weeks	The study assess severity of LUTS in patients with symptomatic BPH using IPSS score before and after antibiotic therapy.

Trial Locations

Locations (1)

BP Koirala Institute of Health Sciences; 🇳🇵 Dharān Bāzār, Koshi, Nepal