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THE MANY ROBOTIC PROSTATECTOMY COMPLICATIONS

B​ert Vorstman MD, MS, FAAP, FRACS, FACS w​ww.urologyweb.com
The robotic prostatectomy is probably associated with more complications than any other surgical procedure. Furthermore, it is the only procedure where its many complications will also impact your spouse/partner and, commonly lifelong.
The following will let you understand why the robotic prostatectomy and its many complications is not for you.
> the dangers of the robotic prostatectomy are clearly evident from a Google search by the endless lawsuits filed against surgeons and the robot device manufacturer
> the scores of self­reported harms listed on the FDA’s own product safety system, MAUDE (Manufacturer and User Facility Device Experience) ­ representing only about 8% of actual adverse events
> the warnings issued by the USPSTF (U.S. Preventive Services Task Force), a Government oversight agency and that the harms of PSA­based prostate cancer screening and treatment outweigh any benefits
> the many warnings from a number of physicians and organizations
> the robot makers themselves who clearly recognize the device dangers for radical prostatectomy as their disclaimers are getting longer with each revision
These many warnings about​the dangers of the robotic prostatectomy are even more egregious when you also realize that:
> the FDA urology panelists approved fraudulently, the robotic device as safe and effective for use in the radical prostatectomy on the basis of some low­level and irrelevant gallbladder studies only and, without a single case of prostate cancer being included in that trial
> the AUA labelled the radical prostatectomy as “standard” for treating the common Gleason 3+3=6 “cancer” which LACKS the very hallmarks of a cancer. In essence, many men are treated for a disease which needs no treatment, undergo surgery with a scientifically unproven device and, are often left limp and leaking
> 2­3% of ALL men diagnosed with prostate cancer will die from their disease but only if they have high­grade prostate cancer. The Gleason 3+3=6 is NOT a health risk
Read More about the many Robotic Prostatectomy Complications >

http://www.urologyweb.com/robotic­prostatectomy­complications/

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​PROSTATE CANCER GRADE CREEP

B. Vorstman MD, MS, FAAP, FRACS, FACS
w​ww.urologyweb.com
The most common cause of prostate cancer grade creep is NOT some progressive worsening of a prostate cancer grade (aggressiveness), but a tendency for some pathologists to overestimate or inflate a Gleason grade and score to have a man thinking that his disease is more significant than it really is. In other words, grade creep is commonly grade inflation.
Currently, many men diagnosed with the Gleason 3+3=6 prostate “cancer” are well aware that this so­called cancer LACKS the hallmarks of a cancer (on both clinical and molecular biology grounds) and that they do not need any treatment. However, men can be deceived into thinking they should be treated if their Gleason grades and score have been inflated.
2­3% of ALL men diagnosed with prostate cancer will die from their prostate cancer but, ONLY if they have high­grade prostate cancer, not the 3+3=6 disease. Furthermore, the 3+3=6 does NOT progress to become high­grade cancer.
Although, it is evident now that the mp­3T MRI (in the right hands) is becoming quite reliable for detecting and diagnosing only the high­grade prostate cancer (and not the 3+3=6 which does not need treatment) to a point where a confirmatory prostate needle biopsy may not even be necessary, MRI prostate cancer screening is yet to be funded by insurance companies. Until then, there are some steps you can take to get some confidence about the real state of your pathology. Many of these steps also, may not be funded by your insurance company but they can be important for those men diagnosed with the Gleason 3+4=7 and those with high volume Gleason 3+3=6 disease. Only high­grade disease needs treatment.
> pathology validation. Any diagnosis of prostate cancer should be validated by an independent pathology reference laboratory to minimize the chance of under­reading or, inflating the Gleason grades and score. Validating your pathological diagnosis is especially important as many pathologists are employed now by robotic or radiation groups and these associations can be affected by the most powerful conflict of interest which is being financially incentivised to “treat” or, not to treat
> biomarkers such as ERG and PTEN immunohistochemistry studies, ProMark (an immunofluorescent study), Oncotype DX and Prolaris (assays the cell cycle gene signature) may assist in identifying more adverse pathology
> a confirmatory 12 core prostate needle biopsy 12 months later
> 6­12 month PSAs, PSA derivatives and PSA density while monitoring PSA kinetics for any persistent upward trending which may suggest the need for another biopsy or mp­3T MRI
Read More About the Deceptions in the Prostate Cancer Arena >
http://www.urologyweb.com/wp­content/uploads/BEWARE­BEWARE­FDA­_APPROVED_­ROBOTIC­PROS TATECTOMY­CARE­1.pdf

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Beware, Beware, FDA “Approved” Robotic Prostatectomy Care

CORAL SPRINGS, FL—MAY 18, 2015— A South Florida‐based urologist today has
issued a stinging report critical of the Food and Drug Administration (FDA) decision
to approve robotic surgery for treating prostate cancer on the basis of only some
low‐level and irrelevant gallbladder studies.

Dr. Bert Vorstman is a proponent of focal therapy in certain cases of prostate cancer
and his dire warnings regarding the misrepresentations, lack of ethics and chicanery
surrounding the robotic prostatectomy have been echoed by a number of physicians
and organizations.

Said Dr. Vorstman, “Not only has the healthcare public been totally duped into
thinking that robotics have been scientifically proven to be safe and effective in the
treatment of prostate cancer (when it has not) but the robotic prostatectomy is
commonly used to treat the Gleason 3+3=6 “cancer” which lacks the hallmarks of a
cancer. In essence, many men are treated for a disease which needs no treatment,
undergo surgery with an unproven device and are often left limp and leaking.”

In his report, Dr. Vorstman added, “The dangers of the robotic prostatectomy are
clearly evidenced by the endless lawsuits filed against surgeons and the device
manufacturer; the scores of self‐reported harms listed on the FDA’s own product
safety system, MAUDE (Manufacturer and User Facility Device Experience)
representing only about 8% of actual adverse events, as well as the warnings
issued by the USPSTF (U.S. Preventive Services Task Force), a Government oversight
agency and the robot makers themselves who clearly recognize the device dangers
as their disclaimers are getting longer with each revision.”

Dr. Vorstman continued, “The intentional withholding of information, deceptions, and distortions regarding the radical prostatectomy being perpetrated now by robotics advocates know no bounds. Even worse than the fraudulent approval of robotics for treating prostate cancer without a single case of prostate cancer ever being tested for that study was the recent shameful FDA denial of the high‐intensity‐focused‐ultrasound (HIFU) application. For this HIFU device evaluation, emboldened FDA urology panelists protected their fraudulently approved robotic prostatectomy franchise even further by conjuring up trial criteria ensuring the HIFU application would fail.”

Furthermore, said Dr. Vorstman, “Embarrassingly, some urologists have stooped
even lower recently by exploiting the medical illiteracy of Senate Staff for a political
pushback on the USPSTF to discredit its “D” grading of PSA‐based prostate cancer
screening and their conclusion that screen‐detected prostate cancer treatment
benefits are outweighed by the harms.”

Dr. Vorstman warned, “The FDA is responsible for protecting the public health by
assuring the safety of medical devices. However, when powerful urologists are able
to penetrate the nation’s oversight agencies and exert influence to satisfy self-serving needs, it signals a dangerous failure of regulatory oversight. Sadly, the need
to protect a surgical “truth” which only urologists can see, has trumped patient
safety in favor of profit.”

To review Dr. Vorstman’s full report, please go to

http://www.urologyweb.com/wp-content/uploads/BEWARE-BEWARE-FDA-_APPROVED_-ROBOTIC-PROSTATECTOMY-CARE-1.pdf

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ROBOTIC PROSTATECTOMY “ FDA APPROVAL” DECEPTION

Bert Vorstman MD, MS, FAAP, FRACS, FACS
www.urologyweb.com

The FDA approval of robotics for prostate cancer treatment in 2000 was based upon a trial conducted by the robotic company itself. Aside from this serious conflict of interest, the trial had two other major problems:
a) the study was undertaken only on diseased gallbladders
b) when the 113 men who had robotic surgery were compared to the 132 men who had laparoscopic surgery, the robotic surgery proved no more effective than the standard and less costly laparoscopic surgery
However, underhandedly, using an arbitrary “soft­tissue” classification to include both the gallbladder and prostate, the FDA urology panelists were able to finagle an “FDA approval” of robotics for “treating” prostate cancer without the device ever having been tested directly on any prostate cancer for safety or effectiveness.
To read more about how these FDA urology panelists pulled off this fraudulent exercise and continue to endorse the radical robotic prostatectomy as “standard”, go to: Beware, Beware FDA “APPROVED” Robotic Prostatectomy Care

Posted in: Prostate Cancer News

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Good long-term cancer control following a laparoscopic surgery for bladder cancer

New findings suggest that long-term survival rates following laparoscopic surgery for bladder cancer are comparable to those of open surgery. Published in BJU International, the largest study to date with long-term follow-up after this type of minimally invasive surgery, indicate that prospective randomized trials comparing these two bladder cancer surgeries are warranted.
The removal of the bladder through open surgery or ‘open radical cystectomy’ is the treatment of choice for muscle invasive and high-risk non-muscle invasive bladder cancer but the surgery can lead to serious complications. Laparoscopic radical cystectomy is still being used by some hospitals but there is little information on the effectiveness of these procedures for preventing cancer recurrence over the long term.

To address this, a large database of laparoscopic radical cystectomy procedures performed across Europe is being built by the European Association of Urology (EAU)-section of Uro-technology. An international team led by Simone Albisinni, MD and Roland van Velthoven, MD, PhD, of the Universite Libre de Bruxelles in Belgium have found from the database that laparoscopic radical cystectomy can lead to reliable cancer control even many years after surgery. About 66 percent of patients had no signs of bladder cancer recurrence after 5 years and among those followed for 10 years, 62 percent had no signs of recurrence.

“Analyzing over 500 patients and with a median follow-up of 5 years, these results are vital to globally evaluate the efficacy of this procedure. They suggest that a laparoscopic approach to bladder cancer, when performed correctly, can be as safe
as open surgery with regards to cancer control, though maintaining the benefits of a minimally invasive approach,” said Dr. Albisinni.
There is a growing interest for robotic-assisted radical cystectomy which the authors noted and another minimally invasive procedure, in the international community as well; however many hospitals in Europe do not own a robot. On the other hand, laparoscopic equipment is more widely available. “As such, this data represents crucial information for urologists who are performing laparoscopic surgery, or who wish to implement laparoscopic cystectomy in their departments. In spite of the technical difficulty and the need for a learning curve, these findings support the use of a laparoscopic approach for the management of bladder cancer,” said Dr. Albisinni.

Posted in: General Healthcare

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Insights into the role of genetic variants in kidney disease

A new research that appeared in an upcoming issue of the Journal of the American Society of Nephrology (JASN) provide insights into the ties between certain genetic variants and kidney disease in African Americans. The genetic association is one of the strongest ever reported for a common disease and these latest study may help improve diagnosis and treatment.

Recent work from several research groups has shown that African Americans have a 4-fold increased risk for chronic kidney disease compared with European Americans and that much of this risk is due to genetic variations in a gene called apolipoprotein L1 (APOL 1). This gene creates a protein that is a component of HDL, or good cholesterol. These variants arose tens of thousands of years ago in sub-Saharan Africa, and so are present in individuals who have recent sub-Saharan African ancestry. Approximately 5 million African Americans are placed at increased risk for kidney disease because most of them carry APOL1 risk variants.

Information on 94 patients with focal segmental glomerulosclerosis (FSGS) were investigates by Jeffrey Kopp, MD (National Institutes of Health) and his colleagues to understand the role of APOL1 variants in a particular form of FSGS. The team found that patients who had APOL1 variants tended to have more advanced disease when they were diagnosed, which fits with prior observations that this genetic form of FSGS progresses rapidly. Previous research has shown that patients with two APOL1 variants respond to glucocorticoids with reductions in urinary protein excretion but they nonetheless may experience progressive loss of kidney function. The present s tudy showed a similar pattern with cyclosporine and mycophenolate mofetil. “New therapies targeting APOL1 injury pathways are needed, as standard therapies do not work for many people with this gene variant,” said Dr. Kopp.

The investigators also found that 72% of self-identified African Americans in the study had APOL1 risk variants, similar to earlier findings. “We also found the APOL1 risk genotype in 2 individuals of Hispanic descent, which is well known, and in 2 individuals who self-identified as White, or European American, which has not been reported before. This last finding suggests that APOL1 risk variants can be present in individuals who self-identify in various ways,” said Dr. Kopp.

In an accompanying editorial, Christopher Larsen, MD (Nephropath) and Barry Freedman, MD, PhD (Wake Forest School of Medicine) write that “the report by Kopp et al. enhances our understanding of a common etiology of the FSGS lesion seen on kidney biopsy in African Americans.” They note, however, that the findings from the trial, although informative, are not encouraging due to the poor outcomes that patients with APOL1 variants often ultimately experience.

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Is a more frequent dialysis schedule efficient?

Patients with End Stage Renal Disease are dialyzed 3 times per week for about four hours each time. The idea to implement a more frequent dialysis schedule seems appealing where observational studies have associated long dialysis intervals with an excess risk of mortality and cardiovascular disease hospitalizations, while on the other hand a rather new study has suggested that daily dialysis might improve left- ventricular mass and health-related quality of life.

Prof. Carmine Zoccali, NDT Editor-in-Chief took the task o analyse the pros and cons if a more frequent schedule really is efficient, e.g. beneficial and economically justifiable. More on his review on this can be read in the January edition of NDT.
There might be a benefit on mortality but, on the other, a more frequent (e.g. alternate) hemodialysis might increase the risk of arteriovenous fistula problems and, thus, increase the disease burden, Zoccali points out. The impact on the outcome has not yet been proven, he emphasized: “Evidence that these regimes are beneficial mainly derives from observational studies and the possibility that the same regimes are harmful cannot be excluded”. As long as new data is missing, there is no need to change dialysis schedules. “Only in problematic patients we should think about pro-actively applying more frequent HD regimes”.

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Links Between Bullying and LUTS in Children

(HealthDay News) – In its February issue publication, The Journal of Urology featured a study that says bullying is associated with 8 to 11 year-olds exhibiting lower urinary tract symptoms or LUTS.

The correlation between pediatric lower urinary tract symptoms and exposure to bullying among 8 to 11 year-olds were examined by Christina B. Ching, M.D., from Vanderbilt University Medical Center in Nashville, Tenn. and her colleagues. Using the Vancouver Symptom Score at a pediatric urology clinic, it was revealed that exposure to school bullying was assessed via the Setting the Record Straight bullying questionnaire among children who were also being assessed for lower urinary tract symptoms. Children presenting for pediatric well visits also completed the questionnaires. Data were included for 113 children at the urology clinic and 63 children in the primary care setting.

Within the urology clinic group, Vancouver Symptoms Score was significantly associated with self-perceived and peer-perceived victimization scores (both P< 0.001) A significant association was also seen between Vancouver Symptom Score and self-perceived (P = 0.01)and peer perceived (P = 0.001) bullying perpetrator scores in the primary care group. 33% of children seen at the primary care office had a significant Vancouver Symptom Score. These observations were significant differences between the two populations, with more perpetrators of bullying in the primary care group (7.9% versus 0.9%; P = 0.02).
“Although bullying exposure is multifactorial, we found that Vancouver Symptom Score can be associated with bullying victimization and perpetrator scores,” the authors write.

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Laparoscopic surgery for bladder cancer leads to good long-term cancer control

Bert Vorstman, MD,MS,FAAP,FRACS,FACS www.urologyweb.com

Findings indicate that long-term survival rates for bladder cancer after laparoscopic surgery are comparable that those of open surgery. The study, published in BJU International indicates that prospective randomized trials comparing these two bladder cancer surgeries are warranted.

A treatment for muscle invasive and high-risk non-muscle invasive bladder cancer is the open radical cystectomy or removal of the bladder through open surgery. The other is chemo-radiation. However, conventional surgery can also lead to serious complications. Laparoscopic radical cystectomy is one of the minimally invasive procedures that some hospitals are using but there is little information on the effectiveness of these procedures for preventing cancer recurrence over the long term.

The European Association of Urology (EAU)-section of Uro-technology has been building a large database of laparoscopic radical cystectomy procedures performed across Europe to address this. Simone Albisinni, MD and Roland van Velthoven, MD, PhD, of the Université Libre de Bruxelles of Belgium lead an international team in exploring this database and found that laparoscopic radical cystectomy can lead to reliable cancer control even many years after surgery. Sixty-five percent of patients had no signs of bladder cancer recurrence after 5 years and among those followed for 10 years, 62 percent had no signs of recurrence.

“Analyzing over 500 patients and with a median follow-up of 5 years, these results are vital to globally evaluate the efficacy of this procedure. They suggest that a laparoscopic approach to bladder cancer, when performed correctly, can be as safe as open surgery with regards to cancer control, though maintaining the benefits of a minimally invasive approach,” said Dr. Albisinni.

The authors noted that there is growing interest for robotic-assisted radical cystectomy, another minimally invasive procedure, in the international community as well; however, many hospitals in Europe do not own a robot. Laparoscopic equipment, on the other hand, is

more widely available. “As such, this data represents crucial information for urologists who are performing laparoscopic surgery, or who wish to implement laparoscopic cystectomy in their departments. In spite of the technical difficulty and the need for a learning curve, these findings support the use of a laparoscopic approach for the management of bladder cancer,” said Dr. Albisinni.

To learn more visit Dr. Vorstman at http://www.urologyweb.com/ exclusive-medical-reports/ Dr. Vorstman also blogs at http://www.urologyweb.com/uro-health-blog/
Contact him directly at bvorstmanmd@gmail.com

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Method to assess UTI risk in women after pelvic-floor surgery

Bert Vorstman, MD,MS,FAAP,FRACS,FACS www.urologyweb.com

The latest issue of PLOS ONE reported that researchers may have found a method to assess the women at risk for developing a urinary tract infection (UTI) following pelvic-floor surgery.

Urinary tract infections (UTI), the most common type of bacterial infection, have estimated treatments costs exceeding USD$1 billion a year in the United States alone. Women who undergo surgery for pelvic-organ prolapsed or urinary incontinence are more likely to develop a UTI following the procedure. Due to a lack of effective methods to identify the risks, clinicians found it difficult to treat specific patients with an increased UTI risk in the past.

Findings found that certain urinary bacteria and antimicrobial peptides, which normally help the bladder immune system function, may identify women at increased risk for a UTI following pelvic-floor surgery.

“This information may help us improve UTI prevention and treatment strategies for women down the road,” said Katherine Radek, PhD, senior author, assistant professor, Department of Surgery and a member of Loyola’s Burn & Shock Trauma Research Institute.

Relationship between urinary bacteria, antimicrobial peptides and UTI symptom severity in 54 women undergoing pelvic-floor surgery were the focus of the study. Participants completed a questionnaire and provided a catheterized urine specimen obtained under anesthesia on the day of surgery. The urine was analysed using advanced DNA-based detection methods. Of these 54 women, 10 or 18.5% developed UTI symptoms after surgery while four or 7% had positive urine cultures after surgery. Thirteen participants, or 24% of the group, had positive urine cultures before surgery. The rest had negative urine cultures before surgery.

Researchers found that the diversity and abundance of specific urinary bacteria and the amount of a specific antimicrobial peptide were different in women who developed a UTI following surgery compared with those who did not: lower risk of post-operatvie UTI correlated with greater bacterial diversity, greater abundance of the Lactobacillus species and higher levels of the antimicrobial peptide β-defensin-1.

Further insight into the mechanisms by which bladder bacteria and antimicrobial peptides communicate during normal and disease states will facilitate the development of better prevention and/or treatment strategies for UTI-susceptible populations.

For more information about various urological conditions, visit Dr. Bert Vorstman at http:// www.urologyweb.com/exclusive-medical-reports/
Dr. Vorstman also blogs at http://www.urologyweb.com/uro-health-blog/
Contact him directly at bvorstmanmd@gmail.com.

Posted in: Womens Health

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