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

NCT06520267 | Completed DMC

• 1 other identifier: IRC/1694/019
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Bacteriuria; Benign Prostate Hyperplasia; Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Severity of LUTS in patients with symptomatic BPH

  4 weeks

Study Arms (1)

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

Interventions

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.

Also known as: Antibiotics

symptomatic BPH

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Male patient with Benign Prostate Hyperplasia
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with symptomatic BPH.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

BP Koirala Institute of Health Sciences

Dharān, Koshi, 56700, Nepal

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine culture and antibiotic sensitivity tests were conducted to assess the bacteriological profile among symptomatic BPH patients.The DNA of these microorganisms can be extracted and analyzed as part of the bacterial evaluation process.

MeSH Terms

Conditions

Bacteriuria; Prostatic Hyperplasia; Urinary Tract Infections

Interventions

Anti-Infective Agents; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal Investigator

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: July 25, 2024
• Study Start: September 1, 2020
• Primary Completion: June 12, 2021
• Study Completion: August 15, 2021
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available after publication of manuscript in the journal.
• 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.

Locations

NE (1)