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OpenTrials
Completed

NCT Number: NCT06520267

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

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.

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Key information

Conditions

Bacteriuria in Symptomatic Benign Prostate Hyperplasia Antibiotic Susceptibility in Symptomatic Benign Prostate Hyperplasia Bacteriuria Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Infections Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Treatment Response to Antibiotics in Symptomatic Benign Prostate Hyperplasia Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

40 year and older

Sex eligibility

Male

Study type

Observational

Primary location

BP Koirala Institute of Health Sciences

Dharān, Koshi, 56700, Nepal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotic therapy

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.

Other names: Antibiotics

Primary outcomes

  1. Identification of common pathogens and Antibiotic susceptibility testing

    Time frame: 4 weeks

    Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile among symptomatic patients with BPH.

Secondary outcomes

  1. Severity of LUTS in patients with symptomatic BPH

    Time frame: 4 weeks

    The study assess severity of LUTS in patients with symptomatic BPH using IPSS score before and after antibiotic therapy.

Sponsors and collaborators

Lead sponsor

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Other

Registry information

Official study title

Prevalence of Bacteriuria, Antibiotic Susceptibility, and Treatment Response in Patients With Symptomatic Benign Prostatic Hyperplasia: a Prospective Observational Study

Acronym: BPH

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 25, 2024
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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