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

NCT ID: NCT06520267

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 131 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-08-15

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.

Conditions

Bacteriuria in Symptomatic Benign Prostate Hyperplasia; Antibiotic Susceptibility in Symptomatic Benign Prostate Hyperplasia; Treatment Response to Antibiotics in Symptomatic Benign Prostate Hyperplasia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

symptomatic BPH

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.

Antibiotic therapy

Intervention Type: DRUG

Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile. The patients were then prescribed antibiotics based on susceptibility testing for a duration of 1 week.

Interventions

Antibiotic therapy

Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile. The patients were then prescribed antibiotics based on susceptibility testing for a duration of 1 week.

Intervention Type: DRUG

Other Intervention Names

Antibiotics

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Tribhuvan University Teaching Hospital, Institute Of Medicine.

OTHER

Sponsor Role: lead

Responsible Party

Ishwor Thapaliya

Prinicpal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

BP Koirala Institute of Health Sciences

Dharān, Koshi, Nepal

Countries

Nepal

Other Identifiers

IRC/1694/019

Identifier Type: -

Identifier Source: org_study_id