Transrectal biopsy slayer now taking on 'complicated' urinary tract infections
Part I
(Been an unusally busy week here at The Active Surveillor: covering Biden’s nodule, federal funding cuts of PCa research, and a urine test giving PSA a run for the money. Plus The Surveillor is preparing a webinar on Saturday. I promise to try to go slower next week. But when prostate news breaks ….
(I know when I run so much news in a week, I risk losing readers. I understand some feel they don’t want this much coverage. One former reader told me he preferred to think about his cancer once a month.
(But as a career journalist, I have news in my DNA. So I feel compelled to cover important stories. . Sorry to lose readers. But I know from reader surveys that others want to know “as much as they can.”
(So I am publishing another story this week on Dr. Truls E. Bjerklund Johansen, whose work led to European urology gudielines giving the nod to transperineal biopsies. And now he is taking on complicated Urinary Tract Infections, which can occur in biopsies and lead to sepsis. This is part I. I am doing another on his work on biopsies.
(Also, I urge you to attend the Surveillor webinar featuring Dr. Jonathan Epstein, the uropathology expert, who will talk about new news in prostate cancer and also will answer your questions.
(The program will be on from noon to 1:30 p.m. Eastern on Saturday, May 17.
(There’s still time to register: https://us02web.zoom.us/meeting/register/JwtdomJnT3mJttTI8urvuQ
By Howard Wolinsky
Without exaggeration, I have compared Dr. Truls E. Bjerklund Johansen, MD, emeritus professor of urology at University of Oslo, Norway and expert on infectious diseases in the field, to Dr. Ignaz Semmelweis, a pioneering Hungarian physician in the 1800s.
Semmelweis discovered that if clinicians disinfected their hands in dealing with pregnant women that infections and deaths could be reduced dramatically. He has been called the “savior of mothers.”
In my mind, Bjerklund Johansen has been the “savior of men”--like most readers here, who undergo serial biopsies to track prostate cancer-- and are potential victims of deadly and disabling sepsis from biopsies.
He campaigned successfully in Norway and then Europe-wide for guidelines that moved the biopsy needle from the germ-infested rectum to the sterile perineum--the area between the anus and the testicles--to avoid infections and sepsis, the worst case.
He told me urosepsis and sepsis deaths largely have disappeared from European hospital urology departments because of a switchover to transperineal biopsies in Europe. This has happened because of guidelines Bjerklund Johansen championed from the European Association of Urologists. BTW, American urologists largely has been dismissed him.
“If you look at sepsis diagnosed in, or brought to urology departments, biopsy-related sepsis used to be the most common, but in Europe we don`t see that anymore. So today, upper tract stones and CAUTI [catheter-associated urinary tract infections] are the most common types of urosepsis in urology departments,” noted Bjerklund Johansen. In 2018, he took on the cause after he discovered a biopsy he had performed led to a patient’s death. The patient’s daughter nudged him into researching the problem--after all of her dad’s other doctors blew her off.
Efforts in the U.S. have been far less successful. American urologists are skeptical that a problem even exists. (I’ll do a follow-up story soon. If you haven’t already, please respond to my survey on transrectal vs. transperineal: https://forms.gle/kiYTuwdyfjYr3R68A?)
Now, Bjerklund Johansen is slaying other dragons relating to urinary tract infectionx (UTIs), especially so-called complicated UTIs (cUTIs.)
In a consensus report in Lancet May 13, Bjerklund Johansen et al. call for a major reform in how cUTIs are studied to help find more effective antibiotics to combat them
(Dr. Truls E. Bjerklund Johansen—University of Oslo)
The expert panel described the growing concern among clinicians of an “unacceptable heterogeneity” in studies--meaning diverse or varied study-, patient- and pathogen characteristics, and hence results in studies of cUTI. (Pathogen = bacteria causing infections)
“Studies have compared apples and pears, and unfortunately there are no new antibiotics in PHARMA’s pipeline,” he said at a time when there is a desperate need for new antibiotics because of antibiotic-resistant, Gram-negative organisms that typically originate in the gut.
Bjerklund Johansen said a study of studies--a meta-analysis--provides “the highest level of evidence, but we cannot do meta-analysis if studies are too heterogeneous. This leads to bias and lack of trust in study findings. Bias is difficult to measure and, therefore, we assessed bias in a consensus process.”
Bjerklund Johansen, lead author of the report, said in an interview: “The criteria used to define a cUTI are too vague and lead to different interpretation and inclusion of different types of patients with different prognosis, especially the risk of recurrence within the observation period and hence the determination of sustainability of the effect of treatment.”
Kymora Scotland, assistant professor in the Department of Urology, Division of Endourology at UCLA and an expert in infections related to kidney stones, who was not part of the panel, explained that the term "UTI" encompasses a broad spectrum of infections.
(Dr. Kymora Scotland—UCLA)
While uncomplicated UTIs in young, healthy women typically responding well to standard antibiotics, are one end of the spectrum, on the other are "complicated UTIs" – those typically occurring in men, individuals with underlying health issues, or those with bladder emptying problems. She said the danger lies in the potential progression: from a localized bladder infection to kidney involvement (pyelonephritis) and, most alarmingly, to urosepsis, where the infection enters the bloodstream, triggering a life-threatening systemic inflammatory response, she said.
How do cUTis impact the health of men undergoing prostate biopsies?
Scotland, vice chair of the Society for Infection and Inflammation in Urology, a subsidiary of the American Urological Association, said cUTIs underscore the vulnerability of certain patient populations, including men undergoing invasive procedures like prostate biopsies.The introduction of bacteria during the biopsy, coupled with individual patient factors, can create a perfect storm for infection and its progression.”
The authors of the Lancet paper emphasized the urgent need for a paradigm shift in cUTI research. Bjerklund Johansen said the findings provide compelling support for a call for action from regulatory bodies like the U.S. Food and Drug Adminsitration (FDA), which sets standards for research, and major medical societies.
They said: “Standardizing study designs, patient criteria, and outcome measures is essential to develop effective treatments, combat antibiotic resistance, and ultimately improve outcomes for patients facing these potentially life-threatening infections, including the specific risks associated with procedures like prostate biopsies. The call for unified guidelines and greater vigilance is particularly pertinent in the context of prostate cancer diagnosis to mitigate this significant and potentially life-threatening complication.”
The very concept of "complicated UTI" as a research entity needs careful re-evaluation to ensure meaningful progress in developing effective treatments and preventative measures based on robust and reliable scientific evidence, they said.
The panel said in closing: “We hope this Review will push regulatory agencies and
international medical societies to prioritize the establishment of an expert panel with a mandate to improve definitions, standards, and phenotyping of patients for the betterment of evaluations of new antibiotics in urinary tract infection. Urinary tract infection remains
an important study field, particularly for antibiotics against Gram-negative pathogens, due to its clinical frequency and the strong likelihood of identifying the causative pathogen
and documenting microbiological treatment effect. Medical societies and regulatory bodies owe developers and patients clear guidance on how to do clinical studies
and improve clinical practice.”
In his concluding remarks Bjerklund Johansen said: “Some authoritative body should take the first step and press the start button. Most studies refer to the FDA guidance and therefore FDA is the most relevant authoritative body. The FDA might nominate a panel and define a mandate, or they could ask EAU, AUA, ESCMID [European Society of Clinical Microbiology and Infectious Diseases] or IDSA [Infectious Diseases Society of America] to come together and define a mandate and nominate a panel, but this approach seems more complicated.”
The FDA declined comment. Scotland said the AUA has guidelines on UTIs and is updating them.
More meetings, including a new one in the Windy City only for AS patients
—Chicago Area Active Surveillors meet in person 11:30. a.m.-1 p.m. Wednesday, May 21,
Be there or be square. But you gotta’ be there in person.
The newly formed Chicago Area Active Surveillors is meeting at
Seasons 52 in the Napa Room
3 Oakbrook Center
Oak Brook, IL 6052
If you want to join us, let me know at howard.wolinsky@gmail.com, and I’ll share details.
We have drawn members from as far away as Columbia, Missouri, for the meeting of what we believe is the largest in-person AS-only support group on the planet—certainly in the Chicago area. Maybe in the multi-verse.
—ZERO’s town hall meeting on ZOOM. Prostate cancer research—along with research on other diseases—has taken a body blow.
Attend a ZERO Prostate Cancer town hall at 7 p.m. Eastern Tuesday May 20 by ZERO to discuss the status of funding cuts under the proposed federal budget and what can be done about it. Register for the session here. More background on the cuts proposed for CDC here.
—UMiami’s Sanoj Punnen takes on the debate over transperineal vs. transrectal biopsies. Active Surveillance Patients International (ASPI)’s monthly webinar will focus on these issues in a program entitled, “The great biopsy debate: Where do we stand on transperineal vs. transrectal?”
The program will be on Saturday, May 24 from noon to 1:30 pm Eastern.
Register here:
https://zoom.us/meeting/register/UZVDHmq9Rlyw6y_mqmK0hg#/registration
Check out Punnen’s presentation of the MAST AS study at the recent meeting of the American Urological Association: https://news.med.miami.edu/improving-prostate-cancer-prediction-during-active-surveillance/
Please send questions in advance to: contactus@aspatients.org