The role of fosfomycin as prophylaxis in

transrectal and transperineal biopsies

Updates on Prostate Biopsy: different techniques and antibiotic prophylaxis

Truls E. Bjerklund Johansen

MD, DMSci, FRCS (Eng), FRSM (UK)
Urology Department, Oslo University Hospital and Telemark Hospital
Trust
University of Oslo, Norway
University of Aarhus, Denmark
Zambon lecture 20. July 2023
Outline
1. About prostate biopsies
2. Nosocomial infections
3. Principles related to infection prevention
4. Principles of antibiotic prophylaxis
5. Antibiotic prophylactic regimens
6. The role of Fosfomycin trometamol
7. The Norway case
8. Conclusions
1. About prostate biopsies
• What is a prostate biopsy?
• How is it evaluated?
• Biopsy approach
• Transrectal
• Transperineal
• Image guidance
• Ultrasound
• MRI
• Fusion
• Cognitive
• Biopsy pattern and number of specimens
• Targeted
• Systematic
• Saturation
• Mapping
1. About prostate biopsies
• What is a prostate biopsy?
• How is it evaluated?
• Biopsy approach
• Transrectal
• Transperineal
• Image guidance Diam 1mm, Length 20mm
• Ultrasound
• MRI
• Fusion
• Cognitive
• Biopsy pattern and number of specimens
• Targeted
• Systematic
• Saturation
• Mapping
1. About prostate biopsies
• What is a prostate biopsy? Microscopy:
• How is it evaluated? • Gleason score
• Biopsy approach • Tumour length
• Transrectal
• Transperineal
• Image guidance Objective:
• Ultrasound • Rule in cancer
• MRI • Rule out cancer
• Fusion
• Cognitive
• Biopsy pattern and number of specimens
• Targeted
• Systematic
• Saturation
• Mapping
1. About prostate biopsies
• What is a prostate biopsy?
• How is it evaluated?
• Biopsy approach
• Transrectal
• Transperineal
• Image guidance
• Ultrasound
• MRI
• Fusion
• Cognitive
• Biopsy pattern and number of specimens
• Targeted
• Systematic
• Saturation
• Mapping
1. About prostate biopsies Side-fire
Bi-plane
• What is a prostate biopsy?
• How is it evaluated?
• Biopsy approach
• Transrectal
• Transperineal
• Image guidance
• Ultrasound
End –fire
• MRI
Transverse plane
• Fusion
• Cognitive
• Biopsy pattern and number of specimens
• Targeted
• Systematic
• Saturation
• Mapping
1. About prostate biopsies Side-fire
Bi-plane

• What is a prostate biopsy?

• How is it evaluated?
• Biopsy approach
• Transrectal
• Transperineal End –fire
• Image guidance Transverse plane
• Ultrasound
• MRI
• Fusion
• Cognitive
• Biopsy pattern and number of specimens Ultrsound image
• Targeted Transverse plane
• Systematic
• Saturation
• Mapping
 MRI- pictures
1. About prostate biopsies
• What is a prostate biopsy? MRI-fusion
• How is it evaluated?
• Biopsy approach
• Transrectal
• Transperineal
• Image guidance
• Ultrasound
• MRI
• Fusion
• Cognitive Finger guidance
• Biopsy pattern and number of specimens
• Targeted
• Systematic
• Saturation
• Mapping
Needle positioning in transperineal bx
 Prostate imaging reporting and data system (PI-RADS)

• PI-RADS 1: very low (clinically significant cancer is highly unlikely to be present)

• PI-RADS 2: low (clinically significant cancer is unlikely to be present)

• PI-RADS 3: intermediate (the presence of clinically significant cancer is equivocal)

• PI-RADS 4: high (clinically significant cancer is likely to be present)

• PI-RADS 5: very high (clinically significant cancer is highly likely to be present)

1. About prostate biopsies
• What is a prostate biopsy?
• How is it evaluated?
• Biopsy approach
• Transrectal
• Transperineal Targeted
• Image guidance
• Ultrasound
• MRI
• Fusion
• Cognitive
• Biopsy pattern and number of specimens
• Targeted
• Systematic
• Saturation
• Mapping
Classical sextant
a.m.Hodges
Systematic
8 – 12 biopsies
EAU guidelines
Saturation
biopsies
Mapping biopsies
Current procedure:
Each octant is divided into
3 zones, midline biopsies
are segregated= 26 zones

W. Barzell, FL: > 100 specimens

Outline
1. About prostate biopsies
2. Nosocomial infections
3. Principles related to infection prevention
4. Principles of antibiotic prophylaxis
5. Antibiotic prophylactic regimens
6. The role of Fosfomycin trometamol
7. The Norway case
8. Conclusions
 Current status on infectious complications after urological procedures

Sources of evidence
• Published series
• Without AP
• With AP
• Registry data Ca. 10% (7-21)
• Comparative studies
• RCTs
• Systematic reviews
Current status on infectious complications after urological procedures
Urodyn studies 6-45%
TURP and TURBT 2.9%
Open prostatectomy SSI 16%
Sources of evidence HOLEP 7.7%
• Published series TUMT 3.3-30%
Urethral sling 2.1-14%
• Without AP Artificial sphincters 1-8%
• With AP Bladder Botulinum toxin inj. 5.8%
Penile prosthesis implant 0.6-22.8%
• Registry data Perc. Nephrolithotomy 3-14%
ESWL 0-12%
• Comparative studies Simple nephrectomy SSI 5%
• RCTs Radical nephrectomy 0-5.2%
RALP 5.6%
• Systematic reviews HIFU 10.8%
Radical cystectomy 15.5-19.5%
Tandogdu Z. Health care associated urinary tract infections in urology departments. Dr. Philos
thesis. Faculty of medicine. University of Oslo, 2020. ISBN 978-82-8377-595-2
Current status on infectious complications after urological procedures

RCTs on prostate biopsy (Modified after Bootsma et al. 2008. Courtesy of Kurt Naber)

Sources of evidence Author

Kapoor et al. 1998
Study type
RCT, double
blind
Population
N=457
Intervention
•
•
Ciprofloxacin 500 mg p.o. SD
Placebo
Outcome
•
•
Bacteriuria
Sympt. UTI
AB
3%
No AB
8%*

• Published series Aron et al. RCT, patient

blinded
230/227
N=457 • Ciprofloxacin 500 mg p.o. SD +
tinidazole 600 mg p.o.
•
•
Bacteriuria
Fever
3%
5-8%
5%
19%*

• Without AP
2000 75/79/77 • Ciprofloxacin 500 mg p.o. bid + • Bacteraem 3% 7%
tinidazole 600 mg p.o. bid 3 days ia 0-1% 3%
• Placebo

• With AP Isen et al.

1999
RCT N=110

23/42/45
•
•
•
Ofloxacin 400 mg p.o. SD
TMP/SMX 160/800 mg p.o. SD
No AB
• Bacteriuria 5-7% 26%*

• Registry data Ruebush et al.

1979
RCT N=89 •
•
TMP/SMX
Placebo
•
•
•
Bacteriuria
Fever
Bacteraem
0% 21%*

18%

• Comparative studies Melekos et al. RCT N=38 • Piperacillin 2 g i.v. bid •

ia
Bacteriuria 9%
70%
31%

• RCTs
• No AB • Bacteraem
1990 16/22 ia 14% 38%
Crawford et al. RCT, patient N=48 • Carbenicillin 3 days • Bacteriuria 9% 36%

• Systematic reviews
blinded • Placebo • Fever
1982 25/23 • Bacteraem 17% 48%
ia 22% 16%
Brown et al. RCT N=19 • Gentamicin 80 mg i.v. • Bacteriuria 44% 20%
• No AB • Fever
1981 9/10 • Bacteraem 50% 22%
ia 40% 33%
Pathogens causing NAUTI
E coli

Pseudomonas

Klebsiella

Enterocooci

Proteus

Staphylococci

Enterobacter

Candida

Others

0 5 10 15 20 25 30 35
% of total
Antibiotic
resistance

All pathogens
Geographic variation of FLQ outpatient prescriptions
vs FLQ resistant HAIs
Courtesy of Jim C. Hu, M.D., MPH

Outpatient FLQ prescription 35.2% Hospital Acquired

1000 population Infections FLQ resistance
 AMR in 2050
10 million

Review on Antimicrobial Resistance

O’Neill Commission, 2015
Outline
1. About prostate biopsies
2. Nosocomial infections
3. Principles related to infection prevention
4. Principles of antibiotic prophylaxis
5. Antibiotic prophylactic regimens
6. The role of Fosfomycin trometamol
7. The Norway case
8. Conclusions
Principles related to infection prevention

• The procedure
• Contamination categories
• The patient
• Patient related risk factors
• The surgeon
• Technical aspects
• The need for Antimicrobial stewardship
Contamination
Surgical wound classification
• I. Clean
• Uninfected operative wound, …no ”bodily tracts” are entered

• II. Clean-contaminated
• Operative wound involving opening of bodily tracts under controlled conditions…

• III. Contaminated
• Open fresh accidental wounds…gross spillage from gastrointestinal tract…

• IV. Dirty-Infected
• Old traumatic wounds with devitalized tissue…clinical infection or perforated
viscera

…Ann Surg 1964;160(Suppl 2):1-132

Transperineal bx.

Transrectal bx.
Patient related risk factors for nosocomial infections
• High age
• Nutritional status
• Low level of albumin
• Anaemia
• Obesity
• Deficiency of immune response
• Inborn
• Acquired
• Co-morbidity
• Diabetes mellitus
• Connective tissue disorder
• Smoking
• Bacterial colonisation and resistance
Infect Control Hosp Epidemiol 1999.20:250-78
ASA physical status classification and risk of complications

Category Patient condition Risk of complication

1 Normal healthy patient No particular
2 Mild systemic disease No particular
3 Severe systemic disease Risk increase
4 Severe incapacitating systemic disease that is Risk increase
constant threat for life

5 Moribund, not expected to survive without High risk

the operation

W J Urol 2012;30:39-50
Principles for Perioperative Antibiotic Prophylaxis

• PAP should never substitute for good medical practices

• Hand hygiene
• Surgical practice
• Instrument sterilization
• Optimization of risk factors
• Perioperative temperature, fluid, oxygenation management, glycemic control
• Appropriate management of surgical wounds
• Antibiotic agents with narrowest spectrum of activity
required for efficacy
• PAP should be administered for procedures associated with
high risk of infection

Adapted from Global Alliance for Infections in Surgery 2023

Classification of UTI

Uncomplicated Complicated
Classification of UTI
Clinical diagnosis Grade of severity

Cystitis 1
Mild and moderate
pyelonephritis 2
Severe
pyelonephritis 3
Uncomplicated Urosepsis (simple)* 4
Complicated
Severe urosepsis* 5

Uroseptic shock* 6
Classification of UTI
Clinical diagnosis Grade of severity Phenotype

Cystitis 1 O
Mild and moderate
pyelonephritis 2 R
Severe
pyelonephritis 3 E

Uncomplicated
Urosepsis (simple)* 4 Complicated
N

Severe urosepsis* 5 U

Uroseptic shock* 6 C
 Host risk factors in urinary tract infections categorized according to
the ORENUC system
Category of risk factor Examples of risk factors Phenotype

NO known risk factor Otherwise healthy premenopausal women O

Sexual behaviour (frequency, spermicide),
Risk factors for Recurrent UTI, but no risk of Hormonal deficiency in postmenopause
more severe outcome Secretor type of certain blood groups R
Well controlled diabetes mellitus

Prematurity, newborn
Pregnancy
Extra-urogenital risk factors with risk of more
severe outcome
Male gender
Badly controlled diabetes mellitus
E
Relevant immunosuppression (not well defined)

Relevant renal insufficiency (not well defined)

Nephropathic diseases with risk of more severe
outcome
Polycystic nephropathy
Interstitial nephritis, e.g. due to analgetics
N
Ureteral obstruction due to a ureteral stone
Urological risk factors with risk of more severe Well controlled neurogenic bladder disturbances
outcome, which can be resolved during therapy Transient short-term external urinary catheter U
Asymptomatic bacteriuria*

Permanent urinary Catheter and non resolvable Long-term external urinary catheter
urological risk factors with risk of more severe
outcome
Non resolvable urinary obstruction
Badly controlled neurogenic bladder disturbances
C

*only under certain circumstances in combination with other risk factors, e.g. pregnancy, urological intervention.
Outline
1. About prostate biopsies
2. Nosocomial infections
3. Principles related to infection prevention
4. Principles of antibiotic prophylaxis
5. Antibiotic prophylactic regimens
6. The role of Fosfomycin trometamol
7. The Norway case
8. Conclusions
 Five key PAP measures from ECDC
Perioperative antibiotic Tasks
prophylaxis (PAP) modality
Modality #1 Multidisciplinary antimicrobial Hospitals should establish a multidisciplinary
management (AM) teams AM team who should develop and implement a
protocol of appropriate PAP
Modality #2 Appropriate timing of PAP PAP should be the responsibility of the
anaesthesiologist
Modality #3 Timing of PAP PAP should be administered within 60 minutes
before incision (except vancomycin and
fluoroquinolones), ideally at the time of
anaesthetic induction
Modality #4 Dosing and duration of PAP Although a single dose is preferred, subsequent
doses should be given depending on
the duration of the procedure and the half-life
of the antibiotic, and if significant blood loss
occurs during surgery
Modality #5 Termination of PAP Continuing antibiotic prophylaxis after the end
of surgery is not recommended
ECDC Systematic review and evidence-based guidance on perioperative antibiotic prophylaxis. Stockholm: ECDC; 2013
 ABP policy and surgical contamination
Surgical contamination Description ABP principle

Clean Urogenital tract not entered No

No evidence of inflammation
No break in technique
Blunt trauma
Clean-contaminated (UT) Urogenital tract entered with no or little (controlled ) spillage. Single dose
No break in technique

Clean-contaminated Gastrointestinal tract entered with no or little (controlled Single dose

(bowel) spillage. No break in technique

Contaminated UT or GI tracts entered, spillage of GI content; inflammatory Single dose or prolonged

tissue; major break in technique; ABP
Open, fresh accidental wounds

Dirty Pre-existing infection; viscera perforation Treatment

Old traumatic wound

EAU Urol Inf Guidelines 2010 MG

Principles for Perioperative Antibiotic Prophylaxis

• PAP should never substitute for good medical practices

• Hand hygiene
• Surgical practice
• Instrument sterilization
• Optimization of risk factors
• Perioperative temperature, fluid, oxygenation management, glycemic control
• Appropriate management of surgical wounds
• Antibiotic agents with narrowest spectrum of activity
required for efficacy
• PAP should be administered for procedures associated with
high risk of infection

Adapted from Global Alliance for Infections in Surgery 2023

 Choice of antibiotic for prophylaxis
• Protocol considerations
• Should not be required for treatment of infection
• Low side effects (C. difficile associated diarrhoea)
• Drug allergy
• Serum creatinine
• Prooven efficacy
• Suitable pharmacokinetic
• Individual patient considerations (Expected bacterial
spectrum, -resistance)
• Recent urine culture results
• Presence of any multi-resistant organisms
• Recent antibiotic exposure
• Evidence of symptomatic infection pre-procedure
Bonkat G et al., EAU guidelines 2023
Outline
1. About prostate biopsies
2. Nosocomial infections
3. Principles related to infection prevention
4. Principles of antibiotic prophylaxis
5. Antibiotic prophylactic regimens
6. The role of Fosfomycin trometamol
7. The Norway case
8. Conclusions
 EAU recommendations over years
EAU 2005 EAU 2014 EAU 2022
Main remarks Poor literature Altemeier Class Poor literature

Cystoscopy Fluoroquinolone or Amino/BLI or C2G 0 0

Prostate biopsy Fluoroquinolone or Amino/BLI or C2G Fluoroquinolone or TMP  SMX or Algorithm fig 4 p52 (TP / TR)
metronidazole
Radical Prostatectomy Fluoroquinolone or Amino/BLI or C2G TMP  SMX or C2G or C3G or « too weak to allow the panel to make recommendations
either for or against antibiotic prophylaxis »
Amino/BLI
Ureteroscopy Fluoroquinolone or Amino/BLI or C2G 0 if uncomplicated stone Trimethoprim or C2G or C3G or Amino/BLI

Partial nephrectomy Fluoroquinolone or Amino/BLI or C2G TMP  SMX or C2G or C3G or « too weak to allow the panel to make recommendations
either for or against antibiotic prophylaxis »
Amino/BLI
TURP Fluoroquinolone or Amino/BLI or C2G TMP  SMX or C2G or C3G or Trimethoprim or C2G or C3G or Amino/BLI
Amino/BLI
TURB Fluoroquinolone or Amino/BLI or C2G Trimethoprim or C2G or C3G or Trimethoprim or C2G or C3G or Amino/BLI
Amino/BLI (if high risk) (if high risk)
 EAU recommendations over years
EAU 2005 EAU 2014
Main remarks Poor literature Altemeier Class Poor literature
« No antibiotic prophylaxis is
Cystoscopy Fluoroquinolone or Amino/BLI or C2G 0 0
recommended for clean
Prostate biopsy Fluoroquinolone or Amino/BLI or C2G Fluoroquinolone or TMP  SMX or operations,
Algorithm figwhereas
4 p52 (TPa/ TR)
single
metronidazole or 1-day dose is
recommended in clean-
Radical Fluoroquinolone or Amino/BLI or C2G TMP  SMX or C2G or C3G or « too weak to allow the panel to make recommendations
contaminated. The approach
Prostatectomy either for or against antibiotic prophylaxis »
Amino/BLI
in contaminated operations
varies with the type
Ureteroscopy Fluoroquinolone or Amino/BLI or C2G 0 if uncomplicated stone Trimethoprim or C2G or C3G or Amino/BLI
of procedure, the level of
Partial Fluoroquinolone or Amino/BLI or C2G TMP  SMX or C2G or C3G or « too weak surgical site
to allow the panelcontamination
to make recommendations
nephrectomy either for or against antibiotic prophylaxis »
Amino/BLI and level of difficulty.
Opening of the urinary tract
TURP Fluoroquinolone or Amino/BLI or C2G TMP  SMX or C2G or C3G or Trimethoprim or C2G or C3G or Amino/BLI
is considered as clean-
Amino/BLI
contaminated surgery. »
TURB Fluoroquinolone or Amino/BLI or C2G TMP or C2G or C3G or Amino/BLI (if Trimethoprim or C2G or C3G or Amino/BLI
high risk) (if high risk)
 EAU recommendations over years
EAU 2005 EAU 2014 EAU 2022

Main remarks Poor literature Altemeier Class Poor literature

Cystoscopy Fluoroquinolone or Amino/BLI or C2G 0 0

Prostate biopsy Fluoroquinolone or Amino/BLI or C2G Fluoroquinolone or TMP  SMX or Algorithm fig. (TP / TR)
metronidazole
Radical Fluoroquinolone or Amino/BLI or C2G TMP  SMX or C2G or C3G or « too weak to allow the panel to make recommendations
Prostatectomy either for or against antibiotic prophylaxis »
Amino/BLI

Ureteroscopy Fluoroquinolone or Amino/BLI or C2G 0 if uncomplicated stone Trimethoprim or C2G or C3G or Amino/BLI

Partial nephrectomy Fluoroquinolone or Amino/BLI or C2G TMP  SMX or C2G or C3G or « too weak to allow the panel to make recommendations
either for or against antibiotic prophylaxis »
Amino/BLI
TURP Fluoroquinolone or Amino/BLI or C2G TMP  SMX or C2G or C3G or Trimethoprim or C2G or C3G or Amino/BLI
Amino/BLI
TURB Fluoroquinolone or Amino/BLI or C2G Trimethoprim or C2G or C3G or Trimethoprim or C2G or C3G or Amino/BLI
Amino/BLI (if high risk) (if high risk)
 EAU recommendations over years
EAU 2005 EAU 2014 EAU 2022 French Guidelines 2023
Main remark Poor literature Altemeier Class Poor literature

Cystoscopy Fluoroquinolone or 0 0 0
Amino/BLI or C2G
Prostate biopsy Fluoroquinolone or Fluoroquinolone or TMP  SMX Algorithm fig (TP / TR) T Perineal: 0
Amino/BLI or C2G or metronidazole T rectal: Fosfomycin or FQ or targeted

Radical Fluoroquinolone or TMP  SMX or C2G or C3G or « too weak to allow the panel to make recommendations 0
Prostatectomy Amino/BLI or C2G either for or against antibiotic prophylaxis »
Amino/BLI
Ureteroscopy Fluoroquinolone or 0 if uncomplicated stone Trimethoprim or C2G or C3G or Amino/BLI C1G or C2G
Amino/BLI or C2G
Partial Fluoroquinolone or TMP  SMX or C2G or C3G or « too weak to allow the panel to make recommendations 0
nephrectomy Amino/BLI or C2G either for or against antibiotic prophylaxis »
Amino/BLI
TURP Fluoroquinolone or TMP  SMX or C2G or C3G or Trimethoprim or C2G or C3G or Amino/BLI C1G or C2G
Amino/BLI or C2G Amino/BLI
TURB Fluoroquinolone or Trimethoprim or C2G or C3G or Trimethoprim or C2G or C3G or Amino/BLI 0
Amino/BLI or C2G Amino/BLI (if high risk) (if high risk)

Courtesy of F. Bruyere
Recommendations on antibiotic prophylaxis in transrectal bx -
EAU guidelines 2023
Antibiotic prophylaxis in
transrectal bx

EAU guidelines 2023

 Antibiotic prophylaxis Urology in Giessen, Germany 2023

Patients with UTI should be treated according to Recommended Standard-Dosage Alternatives in Type 1
susceptibility results antibiotic (< 80kgBW) Beta-Lactam Allergy

Clean interventions without risk factors: no prophylaxis

e.g. Urodynamics, cystoscopy, ESWL
Interventions with risk factors (anatomical anomalies, *Cefuroxim 1 x 1.5g i.v. (<80kg) Cotrimoxazol 1 x 800/160mg i.v.
urine transportation disturbances, urolithiasis, urinary
catheters, recurrent UTI)
Implantation of penis- or sphincter prosthesis *Cefuroxim plus 1 x 1.5g i.v. (<80kg) Cotrimoxazol 1 x 800/160mg i.v. plus
Vancomycin i.v. 1 x 15mg/kgKG i.v. Vancomycin 1 x 15 mg/kgKG i.v.
PCNL, nephrectomy/ partial nephrectomy, radical *Cefuroxim 1 x 1.5g i.v. (<80kg) Cotrimoxazol 1 x 800/160mg i.v.
prostatectomy, semicastration (with/without
prosthesis)
Clean-contaminated oeprations with potential Cefuroxim 1 x 1.5g i.v. (<80kg) Clindamycin 1 x 600mg (<80kg) plus
opening of bowel segments (e.g. cystectomy) plus Metronidazol 1 x 0.5g i.v. Gentamicin 1 x 3 mg/kgKG
Transperineal Prostate biopsy, TURP, TURB *Cefuroxim 1 x 1.5g i.v. (<80kg) Cotrimoxazol 1 x 800/160mg i.v.
*alternatively Ampicillin / 1 x 3.0g i.v With Enterococci Vancomycin instead
Sulbactam of Clindamycin plus Ciprofloxacin or
Aminoglykosid
Outline
1. About prostate biopsies
2. Nosocomial infections
3. Principles related to infection prevention
4. Principles of antibiotic prophylaxis
5. Antibiotic prophylactic regimens
6. The role of Fosfomycin trometamol
7. The Norway case
8. Conclusions
AUA and EAU guidelines 2019
Discussion AUA 2023

Infections ca. 10%

Deaths ca. 0.1%
(2500 deaths in Europe/year)
Discussion AUA 2023

Infections ca 10%
Deaths 0.1%
(2500 deaths in Europe/year)

➢ New regulations
➢ Antimicrobial
stewardship
concerns
 Discussion 2023

Infections ca 10%
Deaths 0.1%
(2500 deaths in Europe/year)

➢ New regulations
➢ Antimicrobial
stewardship
concerns

Slides from EAU 23 with courtesy

of Adrian Pilatz
Discussion 2023

Infections ca 10%
Deaths 0.1%
(2500 deaths in Europe/year)

➢ New regulations
Infections and deaths ➢ Antimicrobial
stewardship
can be brought down concerns
to zero!
The role of Fosfomycin trometamol in transperineal prostate bx
Consensus points
After having reached consensus on all points we
concluded as follows:
Outline
1. About prostate biopsies
2. Nosocomial infections
3. Principles related to infection prevention
4. Principles of antibiotic prophylaxis
5. Antibiotic prophylactic regimens
6. The role of Fosfomycin trometamol
7. The Norway case
8. Conclusions
I Roar Gulbrandsen, 68 years
n
t • TR prostate biopsy after MRI findings
r • Day 1.
o • Lower abdominal pain
d • Malaise
u
• Day 2.
c
• Couldn`t find words
t • Balance problems
i • Loss of lateral vision
o • Apoplexia?
n
• Day 6.
• Mors
 What are the resistance rates?

A
• Ciprofloxacin
U
2012-2018: 13%-40% 12
Percent of patients hospitalized
A 10
with suspected sepsis
• Co-trimoxazole
2 2012-2018: 28-62% 8

0 6

2
4
3 What are the complication rates?
2

2011-2017: 1.5-9% 0
2011 2012 2013 2014 2015 2016 2017
Information and recommendations to
Norwegian men

• The local resistance rates for the most commonly

used prophylactic antibiotics are a cause of concern
• The rate of infectious complications after transrectal
prost. bx is unacceptably high
• Transrectal biopsies should not be done without
rectal swab culture
• Transperineal biopsies should replace transrectal
biopsies
 Reactions
N
o Our chronicle was ridiculed and accused of
r
• false data
w
a
• exaggerations
y • frightening patients
Arguments against us
C • we did not understand sepsis
a • Roar`s death had nothing to do with prostate bx
s
• Health directorate saw no need to change practice
e
A request for compensation to Roar`s relatives was
rejected
A
The aftermath of the Oslo Case
f
t • Urology departments started switching from TR to TP-prostate biopsy almost
immediately after our chronicle
e
• Complication rates were double checked and confirmed, and accusations of false
r data and exaggerations were refuted
m • Roar`s death was regarded a complication of prostate bx and his family received
a financial compensation from The Norwegian System of Patient Injury
Compensation
t
• In 2022 the Norwegian Health Directorate officially ordered Norwegian urologists
h
to replace transrectal with transperineal bx
• Doctors and nurses at Oslo University Hospital are now undergoing obligatory
training courses in diagnosis and treatment of sepsis
• EAU guidelines recommend urologists to switch from TR to TP prostate bx
 Infections per patient Infections per patient
Oslo (%) Norway (%)

A
7
U 7
6
A 6
5
5
4 4

2 3 3
2
0 1
2

1
2 0
0
3 2017 2018
2019 2020 2017 2018
2021 2022 2019 2020
2021 2022

N=2784 N=35143
Outline
1. About prostate biopsies
2. Nosocomial infections
3. Principles related to infection prevention
4. Principles of antibiotic prophylaxis
5. Antibiotic prophylactic regimens
6. The role of Fosfomycin trometamol
7. The Norway case
8. Summary and conclusions
Experience with the GPIU study
Study principles

> 30 000 patients screened

• Altruistic project: Generate evidence –
improve practice

>120 countries
Other benefits for investigators
• Authorship
• Acknowledgement
• Access to data and slide decks

Selected publications 2020

• Joining an international research
association, make new friends

Benefits for departments

• Quality assurance
• Scientific merit
Why we decided to replace the GPIU with Deep-Uro

• Problems with ethical approval in

many countries
• Poor national representation
• Difficulties to get papers published in
high impact journals and inform
guidelines
• Retrospective design
• Random inclusion of study centers
• Poor documentation of how
investigators had been trained for
registering patients
Why we decided to replace the GPIU with Deep-Uro

• Problems with ethical approval in • Address upfront

many countries
• Poor national representation • National coordinators
• Difficulties to get papers published in
high impact journals and inform
guidelines
• Retrospective design • Prospective design
• Random inclusion of study centers
• Poor documentation of how
• Dedicated elite centers
investigators had been trained for • Instruction video
registering patients
How Deep-Uro is organized

ESIU
Chair: Zafer Tandogdu

Research group
Chair: Bela Koves

Deep-Uro
Res. ass: Eva Falkensammer
Deep-Uro study principles

Study platform with cycles of infective complications

incidence connected to discrete trials to de-escalate
antibiotic prophylaxis per procedure.

ECRFs that contain all relevant

risk factors
Updated definitions of infective complications
30-day follow-up
Similarities between PAP and empirical treatment (ET)
When PAP and ET are Egen slide –pil
administrated, we don’t Zaf`s thesis ref
know the identity and
susceptibility profile of
the causative pathogen

This can be predicted

based on local resistance
rates, procedure- and
patient-specific risk
factors and mathematical
modelling
Tandogdu Z. Health care associated urinary tract infections in urology departments.
Dr. Philos thesis. Faculty of medicine. University of Oslo, 2020. ISBN 978-82-8377-595-2
Why

• Did I go through all the principles

• Did I go through all the risk factors
• Did I go through current evidence

I have a dream
Why

• Did I emphasize all the knowledge gaps

• Did I emphasize all the uncertainties
• Did I emphasize all the weaknesses in guidelines recommendations
• Did I emphasize all the limitations in guidelines for individual patients

I have a dream – and a plan

Our dream
• Replace procedure specific with patient specific prophylaxis and treatment recommendations
• Offer individualized, tailored prophylaxis
Geographical, hospital-,
procedure-, patient- and
Our ambition condition specific data etc.
• The Deep-Uro study will fill knowledge gaps and incl. risk acceptance level
enable urologists to develop a personal PAP
calculator

We need PDA
• Dedicated investigators from
• strong urology centres who can commit themselves
• to perform complete Deep-Uro study cycles for a
given procedure and
• help provide high-level evidence to support
• publication in high impact journals and
Patient specific
• inform urological guidelines PAP (or no PAP)
• Dedicated industrial partners
Thanks for your attention!