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

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

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.

Study Overview

• Status: Completed
• Conditions: Bacteriuria in Symptomatic Benign Prostate Hyperplasia; Antibiotic Susceptibility in Symptomatic Benign Prostate Hyperplasia; Treatment Response to Antibiotics in Symptomatic Benign Prostate Hyperplasia
• Intervention / Treatment: Drug: 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 Type: Observational
• Enrollment (Actual): 131

Contacts and Locations

Study Locations

• Nepal
  • Koshi
    • Dharān Bāzār, Koshi, Nepal, 56700
      • BP Koirala Institute of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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. 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. The patients was started on antibiotic therapy for a week based on antibiotic susceptibility testing.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Drug: 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.; Other Names: Antibiotics

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): June 12, 2021
• Study Completion (Actual): August 15, 2021

Study Registration Dates

• First Submitted: July 21, 2024
• First Submitted That Met QC Criteria: July 21, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 21, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Urinary Tract Infection; Bacteriuria; Benign Prostate Hyperplasia
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Urologic Diseases; Disease Attributes; Prostatic Diseases; Urinary Tract Infections; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia; Bacteriuria; Disease Susceptibility; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: IRC/1694/019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Individual Participant Data (IPD) to be shared from this study will encompass demographic details (age, sex), clinical characteristics (severity and duration of lower urinary tract symptoms, baseline IPSS scores), microbiological findings (bacterial species isolated from urine cultures, antibiotic sensitivity patterns), treatment information (antibiotic regimen and duration), and clinical outcomes (post-treatment IPSS scores, follow-up urine culture results). This comprehensive dataset will facilitate in-depth analysis of the impact of antibiotic therapy on symptom relief and bacteriuria in patients with symptomatic Benign Prostatic Hyperplasia (BPH), thereby supporting future research and enhancing clinical management strategies.
• IPD Sharing Time Frame: Data will be made available after publication of manuscript in the journal.
• IPD Sharing Access Criteria: Researchers must provide a clear scientific rationale for requesting the data. Data will be shared upon reasonable request to the corresponding author. Requests must detail the intended use of the data and ensure it aligns with the ethical guidelines, ensuring patient confidentiality.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No