Clinical trial NCT06520267: Prevalence of Bacteriuria, Antibiotic Susceptibility, and Treatment Response in Symptomatic Benign Prostatic Hyperplasia
Official title: Prevalence of Bacteriuria, Antibiotic Susceptibility, and Treatment Response in Patients With Symptomatic Benign Prostatic Hyperplasia: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall 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
Keywords: Bacteriuria
Benign Prostate Hyperplasia
Urinary Tract Infection
Lead sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 131
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Identification of common pathogens and Antibiotic susceptibility testing
timeFrame: 4 weeks
Secondary outcomes:
measure: Severity of LUTS in patients with symptomatic BPH
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Dharān Bāzār
country: Nepal
facility: BP Koirala Institute of Health Sciences
state: Koshi
Study officials:
References: