Microbiology, Antibiotic Resistance, and Risk Factors Associated with Infectious Complications in Patients Undergoing Transrectal Prostate Biopsy.

doi:10.21203/rs.3.rs-4926928/v1

Purpose: Urinary tract infections (UTI) are a potentially fatal complication in men undergoing transrectal prostate biopsy (TRPB). Antibiotic prophylaxis is indicated for every patient and recommendations are vastly empiric or based on older epidemiological data. Adequate antibiotic stewardship tailored to local data is essential to reduce the incidence of MDR bacteria. The aim of this study is to investigate the microbiology in our population and to identify risk factors associated with infectious complications after prostate biopsy.

Methods: A retrospective analysis of prospectively collected data from 531 patients undergoing a TRPB biopsy at a tertiary care center in Mexico City between 2017-2023 was performed. Baseline characteristics, clinica and microbiological data were compared between patients with and without protoperative UTIs. Biniary logistic regression was used to identify risk factors for infectious compliations.

Results: Of the 531 patients, 44 (8.3%) developed UTIs, with 9 (1.7%) requiring hospitalization due to sepsis. Significant risk factors included Diabetes Mellitus (DM), dyslipidemia, and previous abdominal radiotherapy. DM was the only independent risk factor (OR 2.82, CI 95% 1.48-5.39). E. coli was the most common isolate (85.7%), with high antibiotic resistance.

Conclusions: Postoperative UTIs were observed in 8.3% of patients, with DM being the sole independent risk factor. High antibiotic resistance rates in E. coli isolates suggest a need for alternative prophylactic strategies.

Antibiotic resistance

urinary tract infections

prostate biopsy

prophylaxis

Prostate biopsy (PB) is the gold standard for diagnosing prostate cancer, with 1 to 3.4 million procedures performed annually worldwide, 95% of which are transrectal using ultrasound guidance. These biopsies have a significant rate of complications, including minor issues such as dysuria, hematospermia, and hematuria, as well as severe complications like sepsis and septic shock, occurring in 0.4 to 3.4% of cases, often requiring hospitalization and increasing healthcare costs and patient morbidity [1–8].

Various strategies, including antibiotic prophylaxis, are used to reduce the incidence of complications. However, these strategies are often empirical or based on outdated epidemiological data. The rise of multidrug-resistant (MDR) bacteria has further complicated the approach to antibiotic prophylaxis and treatment, highlighting the need for personalized prophylactic strategies for high-risk patients [9–10].

This study aims to investigate the microbiology and antibiotic resistance in patients undergoing transrectal prostate biopsy (TRPB) and identify risk factors for infectious complications.

Study Design and Patient Population

This descriptive study included 531 patients who underwent transrectal prostate biopsy (TRPB) at a tertiary care hospital in Mexico City from 2017 to 2023. Eligible patients were over 18 years old with a suspicious digital rectal exam (DRE), elevated prostate-specific antigen (PSA > 4 ng/dL), or lesions rated as PI-RADS ≥ 3 on MRI. Exclusion criteria were a previous prostate biopsy within six months, anorectal malformations, or active urinary tract infection at the time of the biopsy.

Pre-procedural Preparation

Before TRPB, each patient provided a urine culture to ensure no active infection. If the culture was positive, appropriate treatment was given before the biopsy, followed by a new urine culture to confirm the absence of bacteriuria. Antibiotic prophylaxis was administered, mainly a single dose of 1 g intravenous Amikacin (91.14% of cases), with adjustments based on urine culture results.

Procedural Details

TRPB procedures were categorized into systematic (343 cases, 64.59%) and cognitive (188 cases, 35.4%) biopsies. Systematic biopsies involved taking multiple samples from predefined prostate areas, while cognitive biopsies targeted suspicious areas identified through imaging studies.

Data Collection and Outcome Measures

Data collected included demographics (age, BMI, smoking status, alcohol consumption), clinical history (comorbidities, history of prior infections, laboratory values), and procedure details (number of biopsy samples, prostate volume). Infectious and non-infectious complications were monitored within 30 days post-procedure. For those who developed an infectious complication, a urine culture was taken to describe bacterial frequency and resistance patterns. Microbiological data focused on the frequency and resistance patterns of pathogens isolated from post-biopsy urine cultures.

Statistical Analysis

Statistical analysis was conducted using IBM SPSS v24 software (BM Co, Armonk, NY, USA). Parametric variables were compared using the Student’s T-test, while nonparametric variables were analyzed with the Mann-Whitney U test. Categorical variables were examined using chi-square or Fisher’s exact test. Univariate and multivariate logistic regression models were performed to identify risk factors for infectious complications. A p-value < 0.05 was considered statistically significant.

A total of 531 patients met the inclusion criteria. Among them, 487 were classified as non-infected and 44 as infected, resulting in an 8.3% prevalence of infectious complications. The mean age was 65 years. Non-infectious complications included acute urinary retention (1.5%), rectal bleeding (2.25%), and hematuria (5.64%). Infectious complications primarily presented as UTIs (55.6%) and fever (53.3%).

Baseline characteristics

The mean age of both groups was 65 years. Patients with infectious complications were more likely to have type 2 diabetes mellitus (DM2) (57% vs 29.8%, p = 0.001), dyslipidemia (40.9% vs 24.8%; p = 0.02), and a history of radiotherapy (6.8% vs 1.6%, p = 0.021) (Table 1).

Table 1

Baseline Characteristics of Patients
Variable	Non- infected (n: 487)	Infected (n: 44)	p-Value
Demographic Characteristics
Age	68 ± 7.8	63.72 ± 8	0.001
Weight	74.7 ± 11	77.1 ± 12	0.186
BMI	26.52 ± 3.7	26.86 ± 3.5	0.568
Tobacco use (+)	191 (39.2%)	20 (45.5%)	0.418
Alcohol Use (+)	132 (27.2%)	15 (34.1%)	0.32
Personal Pathological History
Type 2 Diabetes Mellitus (DM2)	145 (29.8%)	25 (56.8%)	0.001
Hypertension (HTN)	226 (46.4%)	20 (45.5%)	0.903
Chronic Kidney Disease (CKD)	48 (9.9%)	5 (11.4%)	0.749
Dyslipidemia	121 (24.8%)	18 (40.9%)	0.02
History of Infections	33 (6.8%)	4 (9.1%)	0.564
History of Cancer	86 (17.7%)	6 (13.6%)	0.5
History of Chemotherapy	26 (5.3%)	1 (2.3%)	0.375
History of Radiotherapy	8 (1.6%)	3 (6.8%)	0.021
History of Surgery	268 (55%)	27 (61.4%)	0.41
Surgical Complications	10 (2.1%)	0 (0%)	0.337
Inmunosuppression	22 (4.5%)	4 (9.1%)	0.178
Hospitalization in the Last 30-Days	15 (3.1%)	3 (6.8%)	0.189
Prior Use of Antibiotics	2 (0.4%)	0 (0%)	0.67
Antecedentes urológicos
Hematuria	65 (13.3%)	8 (18.2%)	0.37
Urolithiasis	66 (13.6%)	7 (15.9%)	0.66
Sexually Transmitted Infections (STIs)	17 (3.5%)	2 (4.5%)	0.718
Lower Urinary Tract Symptoms (LUTS)	385 (79.1%)	32 (72.7%)	0.32
Benign Prostatic Hyperplasia / Obstructive Prostatic Growth	201 (41.3%)	18 (40.9%)	0.96
Instrumentation	153 (31.4%)	17 (38.6%)	0.32
Recurrent Urinary Tract Infections (UTIs)	37 (7.6%)	5 (11.4%)	0.37
Chronic Urinary Catheterization	38 (7.8%)	5 (11.4%)	0.407
Previous Transrectal Prostate Biopsy (TRPB)	134 (27.5%)	11 (25%)	0.72
Notes: DM2: Type 2 Diabetes Mellitus; HTN: Hypertension; CKD: Chronic Kidney Disease; STIs: Sexually Transmitted Infections; LUTS: Lower Urinary Tract Symptoms. Notes: Data includes demographic characteristics, personal pathological history, and urological antecedents for non-infected and infected patients. Values are presented as mean ± standard deviation or number (percentage). a Significant at p < 0.05

Procedure characteristics

The ASA scores and Charlson Comorbidity Index did not significantly differ between the groups (p = 0.998 and p = 0.183, respectively). Laboratory results indicated that infected patients had significantly higher leukocyte (7.2 ± 2.5 vs 6.4 ± 1.77, p = 0.006) and neutrophil counts (64.5 ± 9.8 vs 60.91 ± 9.5, p = 0.018), as well as hemoglobin A1c levels (6.9 ± 1.4 vs 6.7 ± 1.2, p = 0.035). There were no significant differences in hemoglobin, platelets, abnormal urinalysis, or prostate-specific antigen levels. The distribution between systematic (12 cores) and fusion (≥ 13 cores) biopsies was similar across groups (p = 0.425), and prostate volume also showed no significant difference (p = 0.151).

Univariate and multivariate analysis

In a multivariable analysis, DM2 remained the only independent risk factor for UTIs (OR 2.82; 95% CI 1.48–5.39; p = 0.002). (Table 2).

Table 2

Multivariable Logistic Regression
Variable	OR	IC 95%	p-Value
DM2	2.82	1.48–5.38	0.002
Dyslipidemia	1.66	0.85–3.22	0.131
History of Radiotherapy	4.05	0.95–17.27	0.058
Notes: Multivariable logistic regression analysis identifying independent risk factors for urinary tract infections (UTIs) post-transrectal prostate biopsy (TRPB). OR: Odds Ratio; CI: Confidence Interval; DM2: Type 2 Diabetes Mellitu

Complication Rates

Overall, we observed a complication prevalence of 14.87%, with 10.73% for hemorrhagic complications and 8.1% for infectious complications. Notably, 9 patients (11.39%) required hospitalization for the management of these complications. The average time from the procedure to presentation at our emergency department was 2.1 days, with the first 48 hours being critical for the development of complications.

Microbiological Findings

Of the patients who developed infectious complications, 28 (63.6%) had positive urine cultures. Escherichia coli was the most frequently isolated pathogen (24 cases, 85.71%), including one case of extended-spectrum beta-lactamase (ESBL)-producing E. coli. Other pathogens included Enterococcus faecium, Serratia marcescens, Enterococcus faecalis, and Raoultella ornithinolytica (each accounting for 3.57% of cases). The resistance patterns of these isolated pathogens are detailed in Table 3.

Table 3

Resistance Pattern of Isolated Bacteria in Patients with Infectious Complications Following Transrectal Prostate Biopsy
Pharmacological group	Drug	E. coli	E. faecium	Serratia marcesenses	E. faecalis	Raoultella ornithonolytica
Aminoglycosides	Gentamicin, Amikacin	4 (16.6%)	0 (0%)	0 (0%)	1 (100%)	0 (0%)
Folate Synthesis Inhibitors	TMP/SMX	8 (33.33%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Quinolones / Fluoroquinolones	Norfloxacin, Ciprofloxacin	15 (62.43%)	0 (0%)	0 (0%)	0 (0%)	1 (100%)
Phosphonates	Fosfomycin	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Nitrofurans	Nitrofurantoin	1 (4.16%)	0 (0%)	1 (100%)	0 (0%)	0 (0%)
Beta-lactamase Inhibitors + Penicillins	Ampicillin/Sulbactam, Piperacillin/Tazobactam	2 (8.33%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Cephalosporins 1st Generation	Cefazolin, Cefalotin	7 (29.1%)	0 (0%)	1 (100%)	0 (0%)	0 (0%)
Cephalosporins 2nd Generation	Cefuroxime, Cefoxitin	7 (29.1%)	0 (0%)	1 (100%)	0 (0%)	0 (0%)
Cephalosporins 3rd Generation	Ceftazidime, Ceftriaxone	11 (45.83%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Carbapenems	Doripenem, Ertapenem, Imipenem, Meropenem	4 (16.64%)	0 (0%)	0 (0%)	0 (0%)	1 (100%)
Penicillins	Amoxicillin/Clavulanate, Ampicillin	15 (62.43%)	1 (100%)	0 (0%)	0 (0%)	1 (100%)
Oxazolidinones	Linezolid	0 (0%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Notes: The table illustrates the resistance patterns of isolated bacteria to various antibiotics. TMP/SMX: Trimethoprim/Sulfamethoxazole; ESBL: Extended-Spectrum Beta-Lactamase. Data Source: Instituto Nacional de Ciencias Médicas y Nutrición “Salvador Zubirán”

Antibiotic Resistance Patterns

The resistance patterns of isolated pathogens are shown in Fig. 1. The high level of resistance to commonly used antibiotics underscores the challenge in selecting effective prophylactic regimens in this patient population.

Our study highlights the significant risk of infectious complications following TRPB, particularly among patients with type 2 diabetes mellitus (DM2). The overall complication rate of 14.87% aligns with existing literature, which reports similar rates of hemorrhagic and infectious complications, ranging from 2–7%, associated with a 2.65-fold increased risk of hospital readmission _[11−15] and higher associated costs _{[9, 15]}.

The predominance of Escherichia coli, including ESBL-producing strains, reflects global trends and underscores the need for effective antimicrobial stewardship. High resistance to commonly used antibiotics presents a significant challenge for selecting effective prophylactic regimens. ESBL-producing bacteria, resistant to key antibiotics such as fluoroquinolones and aminoglycosides, are found in 10–30% of patients. These resistances have substantial implications for prophylaxis and treatment of complications, as many urological procedures could become excessively risky without effective antibiotics _[16−26].

The higher incidence of infections in patients with DM2, dyslipidemia, and prior radiotherapy indicates the need for rigorous preoperative assessment and tailored prophylactic measures. DM2, identified as an independent risk factor (OR 2.82; 95% CI 1.48–5.39; p = 0.002), emphasizes the importance of addressing this comorbidity in TRPB. Additional risk factors include recent hospitalization, antibiotic use, cardiovascular disease, psychiatric disorders, dementia, and urinary tract abnormalities _[27−29].

Given the high incidence of antibiotic-resistant infections, alternative prophylactic strategies should be considered, including pre-procedural rectal swabs to identify resistant organisms and rectal cleaning with povidone-iodine combined with targeted antibiotic therapy, significantly reducing UTI likelihood. Extending the duration or broadening the spectrum of antibiotic prophylaxis could benefit high-risk groups, particularly those with DM2. AUA and EAU guidelines recommend a single dose or at least a full day of antibiotics before TRPB, with antibiotic choice guided by local resistance patterns _[30−35].

A major strength of our study is its large sample size and comprehensive analysis of demographic and procedural factors. However, its retrospective design and single-center setting may limit generalizability. Additionally, reliance on medical records could introduce selection bias or data inaccuracies.

Further research is needed to evaluate the efficacy of alternative prophylactic protocols and identify additional risk factors for postoperative infections. Prospective studies are essential to assess intervention effectiveness in reducing infection rates. Investigating the impact of patient education on reducing self-medication and ensuring timely medical interventions is also crucial.

In our study, the incidence of postoperative UTIs following TRPB was 8.3%, with sepsis and septic shock occurring in 1.69% of cases. DM2 was the only independent risk factor for UTIs, highlighting the need for tailored prophylactic approaches in this high-risk group. Escherichia coli was the most frequently isolated pathogen, showing significant resistance to standard antibiotics, which underscores the challenge of antimicrobial resistance.

These findings support the need for personalized and evidence-based prophylactic strategies, particularly for patients with DM2. Future research should focus on validating these strategies through prospective, multicenter studies and exploring the efficacy of alternative prophylactic measures.

Compliance with Ethical Standards

Funding: The authors did not receive support from any organization for the submitted work.

Competing Interests: The authors have no relevant financial or non-financial interests to disclose.

Ethical Approval: Aproved by the institutional review boards at the Instituto Nacional de Ciencias Médicas y Nutrición “Salvador Zubirán”

Informed Consent: Informed consent was obtained from all individuals participants included in the study

Author contributions:

H. E. Lagos-Beitz: Conceptualization, Data collection and Manuscript writing

G.H. Martinez-Delgado: Data analysisi and Mansucript editing

W. Gonzalez-Sosa: Data collection

G. Trujillo-Martínez: Data analysis

R. Escalante-Armenta: Mansucript writing

G. Tena-González-Méndez: Data analysis and Mansucript editing

R.A. Castillejos-Molina: Data analysis and Mansucript editing

G. Feria-Bernal: Mansucript editing

A. Garza-Gangemi: Project development and Manuscript editing

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No competing interests reported.

Microbiology, Antibiotic Resistance, and Risk Factors Associated with Infectious Complications in Patients Undergoing Transrectal Prostate Biopsy.

Status:

Version 1

Abstract

Figures

Introduction

Materials and methods

Study Design and Patient Population

Pre-procedural Preparation

Procedural Details

Data Collection and Outcome Measures

Statistical Analysis

Results

Baseline characteristics

Procedure characteristics

Univariate and multivariate analysis

Complication Rates

Microbiological Findings

Antibiotic Resistance Patterns

Discussion

Conclusions

Declarations

References

Additional Declarations

Status:

Version 1