Prostate cancer screening
Alternative and generic drug substitution
Androgen deficiency and testosterone replacement therapy
Pelvic floor surgery
Advanced and complicated procedures
Prostate cancer screening: A message to my patients
Screening for prostate cancer has been highly controversial and is becoming increasingly complicated.
About 3% of men die from prostate cancer. By the age of 70 years, about 70% of men who die from unrelated causes have some prostate cancer if careful autopsy is performed. Most deaths from prostate cancer occur at an old age, so a longer life expectancy increases the probability that prostate cancer will be the cause of death.
For over 20 years, screening for prostate cancer has included a PSA blood test and a digital rectal exam (DRE). Treatment choices included surgical removal of the prostate, external radiation therapy, and implanted radioactive seeds. Sometimes injections to stop testosterone production were added. The medical industry has invested heavily in the screening and treatment of prostate cancer, and a 10 billion dollar per year industry has developed.
Analysis of decades of data concluded that the PSA screening program was a failure. The United States Preventative Services Task Force (USPSTF), American Association of Family Practice (AAFP), and American College of Physicians all agreed that screening for prostate cancer with PSA and DRE caused more harm to patients than benefit. Under political pressure from vested financial interests including the American Urological Association (AUA), the USPSTF backed down and stated that PSA was a reasonable option for limited ages if the patient was fully informed of the risks.
The harmful aspects of screening require some explanation. Screening does decrease by about 20% the probability that prostate cancer will be the cause of death. The biopsies and treatments clearly degrade the quality of life, and they may even hasten death from other causes related to the treatment, thereby reducing the probability of death from prostate cancer. Furthermore, most patients with aggressive prostate cancer will die from the cancer regardless of our best efforts for early diagnosis and aggressive treatment. For these patients, the treatments may degrade the quality of their remaining years of life.
All of us will die from something. In general, we care about the length of our lives and the quality of our lives. Medical science uses a metric called the “quality adjusted years of life”. For example, a year with incontinence may be only 80% as valuable as a year with perfect health. A year bedridden and unresponsive may be worth almost nothing to most of us. Emotional stress and cost (by decreasing our other opportunities) may be factors in decreasing our quality of life.
In summary, and based on the best available evidence, prostate cancer screening with PSA and DRE appears to decrease our quality adjusted years of life.
Subsequent to the unfavorable assessment of prostate cancer screening with PSA and DRE, the medical industry has been working to improve the results of screening. Initiatives include the following:
· Low-risk cancers are not always aggressively treated. Active surveillance or even simple follow-up with PSA testing may be chosen if the identified cancer is small and the cells appear to be less aggressive.
· Screening should be limited to healthier patients.
· All patients with a high PSA may not be biopsied. Additional tests may be used to increase the probability that only patients with significant disease will be biopsied.
· Repeat biopsies can be performed more selectively based on special testing of the original biopsy specimen or based on the results of an MRI of the prostate.
These newer approaches are complicated and expensive. The costs for a patient to decide whether to biopsy or treat can add up to $10,000-$20,000 even before establishing a diagnosis or deciding about treatment. There is no general agreement about the best approach.
I have been carefully following the process of developing a new approach to the screening and treatment of prostate cancer. Marketing from the vested financial interests has been overwhelming. It is essential to not only look at the raw scientific data but to also consider the source. My opinions follow:
· The probability that prostate cancer screening may offer benefit is slowly improving, and the risk of harm may be slightly decreasing.
· The costs of these new tests are overwhelming and not affordable for a mass screening program.
· At this time there is still no good evidence that prostate screening, biopsies when recommended, and treatment as currently advised result in a net improvement in the quality adjusted years of life.
· I consider prostate screening, even with today’s tools, to be a bad gamble.
· Continuing research is appropriate.
The diagnosis of Cancer elicits a basic response of fear that frequently exceeds the severity of the problem. Most of us have known people who have suffered or died from cancer. While cancer may be a serious disease that may be fatal, urinary tract cancers are more commonly manageable chronic problems that are cured or that persist allowing the patient to die of old age or from other causes.
Using modern techniques for screening and early detection, we commonly diagnose kidney and prostate cancers that are so early that the patient would die of old age before the cancer were to cause problems even it the cancer were never diagnosed or treated. Not infrequently, the treatment is worse than the disease.
At the same time, urinary tract cancer is a common cause of serious illness and death. The challenge is to decide what, if any, treatment is appropriate for each patient. It’s not always possible to be certain.
Prostate cancer is the most prevalent cancer in men and it is the second most common cause of cancer death in men. Over half of men who die from other causes have prostate cancer, and about 20% of men over 50 years old will be found to have prostate cancer if the prostate is biopsied. About 3% of American men die from prostate cancer, and a high percentage, perhaps most, of these fatal cases will not be cured by current approaches of screening and biopsy. Today’s challenge is to help patients with potentially fatal cancer yet to avoid harming those with insignificant cancer. In this endeavor, we fail more often than we succeed.
Bladder cancer is common and generally presents with bloody urine. While these tumors are almost always considered malignant, over 80% are easily managed by removal through the urethra and without an incision. Like most skin cancers, these low grade bladder cancers almost never spread or cause fatality, but they commonly recur in different areas of the bladder and urinary tract. More aggressive bladder cancers do occur in a minority of patients. These aggressive bladder cancers may require complicated major surgery and they are commonly fatal. The challenges for low grade bladder tumors are to prevent recurrences and to monitor adequately but not excessively. The challenges for aggressive bladder cancer are to decrease the fatality rate by properly timed extensive surgery and to manage patients who are not cured by surgery alone.
Kidney cancer has become much more common, primarily because new imaging techniques can identify much smaller tumors than were previously detectable. In the past, total removal of the kidney including surrounding structures was standard treatment for kidney cancer. Recent studies have identified a high risk of kidney failure leading to dialysis or death in patients with kidney cancer managed by complete removal of the kidney. Particularly in patients with smaller cancers, partial removal of the kidney has been proven to be adequate treatment. A large percentage of small, incidentally detected kidney cancers have been shown not to grow significantly over many years; accordingly, observation alone may be preferable in some patients. The challenges for kidney cancer are to avoid over-treatment of patients with small and non-aggressive tumors and to improve the treatment of patients with aggressive tumors that are not cured by surgery alone.
Testicular cancer is a disease of younger men. Therapy has been with a combination of surgery, chemotherapy, and radiation therapy. Using modern therapies, the cure rate is over 90%, and even patients with advanced disease are commonly cured. Nevertheless, fatal outcomes still occur. Today’s challenge is primarily to reduce the morbidity of treatment while maintaining the same high rate of cure.
When I retired from my practice of urology in Ohio, I turned over to my many younger partners the management of hundreds of patients that I managed with diagnosed genitourinary cancer. I had performed major surgery on some, others underwent only minor procedures, and others were simply observed. Not all of these patients were cured of their cancer, but few of them will die from that cancer. Almost all will die from old age or other diseases.
The treatment of urinary tract cancer should be based not on fear, but on scientific evidence and good clinical judgment. It’s important for patients with cancer to recognize that cancer is frequently a chronic disease, not unlike diabetes or heart disease. Properly managed, most patients with a diagnosis of genitourinary cancer will grow old and die from something else. It’s unreasonable to greatly compromise the quality of life unless the gain from treatment justifies the sacrifice.
Cystoscopy or a cystoscopic exam is the standard procedure to visually examine the inside of the urethra and bladder. The test is often advised to evaluate voiding difficulty, urinary infections, or blood in the urine.
The test involves passage of a tube up the urethra and into the bladder. Water flows through the tube to hold the urethra and bladder away from the lens. A fiberoptic system illuminates the urintry tract, and a system of lenses or fiberoptics allows visualization of the inside of the lower urinary tract. The test can be performed with either a rigid or a flexible cystoscope.
Discomfort is generally mild and tolerable without anesthesia, particularly when a flexible cystoscope is used. Local anesthesia has been shown not to decrease discomfort and is not generally used. The test frequently takes only 1-2 minutes to perform. Temporary burning with urination is common following the procedure.
Complications are generally mild and infrequent. Urinary infection occurs in about 1% of patients and is usually easily treated with antibiotics. Because the risk of side effects exceeds the usual benefit, preventative antibiotics are not advised in most cases. Injury to the urinary tract is rare in the absence of underlying abnormalities.
The best advice that I can offer is to relax the pelvic muscles and to focus your attention on something else. The procedure will be over quickly.
Ultrasound Guided Prostate Biopsy
Ultrasound guided needle biopsy of the prostate is the standard procedure to diagnose prostate cancer that is suspected based on PSA screening or abnormal digital rectal exam.
Biopsy identifies not only the presence of prostate cancer but also provides information about the extent and aggressiveness of the cancer. Biopsy is imperfect and may miss small cancers in the prostate.
Performance of the biopsy involves the placement of an ultrasound probe through the anus into the rectum to image the prostate. A biopsy needle perforates the rectal wall to obtain samples of the prostate. Each biopsy is rapidly performed using a spring-loaded device. The location of biopsies is determined using the ultrasound imaging and is based on extensive experience from thousands of patients. Also, based on extensive experience, about 12 needle biopsies are generally obtained during the procedure.
Specialized centers are offering prostate MRI to aid in the localization of possible cancer and help direct biopsy. Standards and techniques continue to evolve.
Needle biopsy of the prostate involves a limited degree of discomfort. Insertion of the probe is mildly uncomfortable for many patients. The actual needle biopsies generally cause only mild discomfort for most patients, but some patients experience more pain than others. Local anesthesia may be helpful.
The primary risks of prostate biopsy are infection and bleeding. A single antibiotic dose is advisable just prior to the procedure. Additional antibiotics generally cause more side effects than benefit and are reserved for patients who experience fever following the biopsy. Enemas and bowel preparation have not been found to greatly decrease the risk of infection.
Bleeding can occur from the rectal wall of from deeper structures. Rarely, fulguration through an endoscope may be required to control bleeding. It is important to avoid anticoagulants such as aspirin, Plavix, or coumadin prior to the biopsy. Some of these drugs need to be stopped several days prior to the biopsy.
Alternative and Generic Drugs
Prescribed drugs are traditionally selected on the basis of benefit and risk. Cost can also be an important consideration. My goal is to help you make the best selection for your personal situation.
In general, I will initially recommend what I consider to be the best drug available. If an equally desirable generic drug or less expensive alternative is available, I will recommend the less expensive drug.
Even when brand names are prescribed, pharmacists may automatically substitute drugs that are legally determined to be generic equivalents unless the prescription specifically forbids substitution. Sometimes the generic drugs are truly equivalent, and sometimes there is a significant difference. Generic equivalence is a legal rather than a scientific determination.
Frequently, the difference in effectiveness between the best drug available and an alternative is small while the cost difference can be enormous. A reasonable person might well select the less expensive alternative.
Please inform me of your financial concerns about obtaining prescriptions. I’ll be happy to discuss less expensive alternatives along with the associated differences in benefit and risk.
I have an open mind about alternative therapies. Often, effective treatments are not marketed or recommended for finincial rather than medical reasons. FDA approval is expensive, and without patent protection to assure a profit, no company is willing to assume this cost.
Information about nutritional supplements and dietary measures that have been demonstrated to be scientifically effective in managing urology conditions can be found at www.theralogix.com.
Androgen Deficiency and Testosterone Replacement Therapy
What is normal?
Testosterone levels in normal men vary significantly throughout the day and are generally higher early in the morning. Random testing may yield subnormal results in men who generally have normal levels. In young men, 98% of total testosterone is either tightly bound to hormone binding globulin or loosely bound to albumin. Only about 2% of the total testosterone is unbound and biologically available. The lower limit of normal is about 200-300. The average testosterone level gradually declines with age. The pharmaceutical industry has attempted to claim that a high percentage of older men are "abnormal" based on normal values for young men. Perceptions have been greatly distorted by enormous financial interests and related marketing.
I have seen no good evidence that androgen replacement therapy is either safe or effective when given to men with physiologic moderately low testosterone levels. I do not recommend and have never recommended testosterone replacement therapy for these individuals.
An abnormal random total testosterone level is unreliable and inadequate to establish a diagnosis of androgen deficiency requiring lifelong therapy. Confirmatory testing is needed.
Symptoms of androgen deficiency include lack of libido, poor sexual function, lethargy, weakness, and depression. These symptoms are not specific for androgen deficiency. The placebo effect from any therapy for these symptoms is substantial; accordingly, a therapeutic trial is a poor test of the effectiveness of androgen replacement therapy. Men with these symptoms and with mild decreases in testosterone have not been shown to have improved symptoms with androgen replacement, and men with mild decreases in testosterone level do not have an increased probability of having these symptoms.
Who should be tested?
Patients with erectile dysfunction, loss of libido, lethargy, and depression may suffer from androgen deficiency and may benefit from testing. Patients who fail to develop normal adult male characteristics should be tested.
A morning total testosterone level is a reasonable screening test for patients with loss of libido, sexual dysfunction, or other symptoms suggesting androgen deficiency. Evaluation is clearly indicated for patients with infertility, failure to undergo normal male maturation or signs of hypogonadism.
In the absence of clearly defined pathology, such as anorchia (no testicles), patients with an abnormal total testosterone should be further evaluated before committing to long term androgen replacement therapy. Generally, a serum free testosterone, prolactin, LH, and FSH are appropriate. Decreased levels of FSH or LH or an elevated prolactin level may indicate further evaluation of the pituitary gland including imaging with MRI.
A clearly decreased morning serum free testosterone combined with a very low or very high serum LH strongly suggests a diagnosis of androgen deficiency in a symptomatic patient. A mild decrease in serum free testosterone along with a normal LH suggests a normal physiologic decrease in testosterone.
Androgen replacement therapy.
Symptomatic males with clearly defined androgen deficiency and not interested in fertility may benefit from androgen replacement therapy. Men with clearly defined hypogonadism clearly benefit from androgen replacement therapy. Androgen replacement therapy is inappropriate in men who are attempting to reproduce. Gonadotropin therapy is needed to stimulate sperm production in these patients.
Androgen replacement therapy is expensive, and long-term treatment is associated with risks and potential adverse consequences. This treatment should be offered only when the risks clearly outweigh the benefits. The consequences of under-treatment are limited to inadequate symptomatic relief and perhaps a mild increase in the risk of osteoporosis. Treatment beyond the point of symptomatic relief probably offers little value in the middle aged or older male.
Follow-up testosterone levels should be obtained on patients who continue to have symptoms of androgen deficiency while on therapy. Because symptoms of erectile dysfunction, lethargy, and depression are frequently unrelated to androgen deficiency, resolution of symptoms is often incomplete or absent. An increase in the dose of medication in the face of a normal testosterone level is unlikely to be beneficial, and potential adverse consequences are possible.
Adverse consequences of Androgen Replacement Therapy.
Testosterone replacement therapy interferes with the normal production of gonadotropins and arrests the normal testicular production of testosterone and sperm. This interferes with fertility, and it alters the normal pattern and ratio of sexually active hormones in the body. In the short and median term these changes are reversible.
Excessive levels of androgens may cause polycythemia, excessive virilization, emotional lability, hyperlipidemia, worsening congestive heart failure, and (rarely) liver abnormalities. Prostate enlargement may result, and an increase in the growth of prostate cancer may occur. Multiple studies have shown a 30%-50% increase in the probability of heart attack, stroke, and all cause mortality for individuals who take testosterone therapy for physiologic low testosterone of aging.
Regular testing is advised for patients using androgen replacement therapy. Since the intent of therapy is only to restore normal androgen levels, the rational behind these recommendations is questionable; nevertheless, physicians have difficulty not following established standards. Serum hemoglobin, lipid levels, liver function tests, and prostate specific antigen are commonly tested on a routine basis in patients receiving androgen replacement therapy.
Oral: Testosterone is digested and inadequately absorbed if given orally. Fluorinated testosterone (Halotestin) has been shown to cause significant risk of liver damage and is rarely used. No acceptable oral preparation is available.
Intramuscular: Testosterone enanthate and testosterone cypionate are available in oil suspension for intramuscular administration. These preparations deliver the highest serum testosterone concentrations within about 3 days of injection and deliver a declining level over the next few weeks. Even with weekly administration, variability in serum levels can cause mood alterations and other symptoms.
Dermal patch: Dermal patches to be applied to the scrotum or to other areas of the skin are available. These patches are applied daily and can deliver testosterone with a reasonably physiologic diurnal pattern. Generally, delivered drug is about 4-6 mg per day. Inconvenience and skin irritation have been problems.
Transdermal testosterone gel: Application of testosterone gel (Androderm, Testim), when applied daily, has been demonstrated to maintain fairly constant serum levels of testosterone in the physiologic range. Transference to others can be a problem. Although expensive, transdermal gel seems to have the best patient acceptance.
Pelvic floor surgery
Female pelvic floor surgery for stress incontinence and pelvic relaxation has evolved substantially over the past several years. While long-term success has improved in many ways, the complexity, the risk of complications, and the costs have greatly increased. Fellowship training in pelvic floor surgery following the completion of a standard urology residency is now common.
The placement of permanent mesh made from braided polypropylene and other materials has become standard. Large sheets of this material are sometimes placed around the urethra, below the bladder, and above the rectum to provide permanent support. The material may be attached to the sacrospinous ligament, high in the pelvis, to suspend the top of the vagina.
Although early reports suggested a high degree of success with a low risk of complications, later reports told a different story. While many patients have an excellent result, the risks of failure, minor complications, and even devastating complications are much higher than originally reported. Up to 25% of patients develop increased urinary frequency and urgency. Complete retention of urine can occur. Erosion of the mesh into the vagina requiring surgical correction commonly occurs, and devastating erosion of the mesh into the bladder or urethra isn’t rare. Longstanding pelvic pain and painful intercourse can occur.
Medical device manufacturers are frequently introducing expensive new products for use in pelvic reconstruction. The approval of these devices is supported by favorable results from experienced pelvic floor surgeons. Profit for the medical device industry and for the operating surgeon is consistently high. Excessive complication rates seem to be reported only following a few years of experience. In my opinion, recommendations for complex pelvic floor surgery are frequently driven by profit rather than patient benefit and inadequately trained surgeons may be performing many of these procedures.
My personal attitude about complex pelvic floor reconstruction is conservative. I have a low tolerance for life-changing complications and frequent surgical revisions following treatment for medical conditions that are not life threatening. In my former urology practice in Ohio, I performed a large volume of pelvic floor reconstructive surgery between 1980 and 2002. My results were excellent. Around 2002, when mesh implants became common, my group hired a fellowship trained pelvic floor surgeon to whom I referred most of my patients with pelvic floor problems. I noticed that the fellowship trained partner had generally good results, whereas my other partners had a high rate of complications from pelvic floor surgery.
As your urologist, I will be happy to evaluate your problems with urinary incontinence and pelvic floor relaxation. I’ll provide routine medical therapy when appropriate. I can advise you about all surgical options including the risks and benefits of complex surgical repair. In the event that you need or are considering a complex reconstructive procedure, I believe that your interests are best served by referral to an experienced pelvic floor surgeon in a major medical center. This type of surgery is not required urgently, the risks are substantial, and the results are highly dependent on the expertise of your surgeon.
Circumcision, the removal of the foreskin, is commonly performed in newborn males and may be appropriate for medical reasons in adults. The most common indications for circumcision in adults are inability to retract the foreskin (phimosis) and infection under the foreskin (balanitis). Occasional indications are less frequent.
Preventative circumcision may be appropriate. Circumcision has been shown to reduce the risk of urinary infections in infant males, and circumcision greatly decreases the risk of heterosexual transmission of AIDS and other sexually transmissible diseases in adults. Opinions vary regarding the effect, if any, of circumcision on sexual satisfaction.
Techniques for circumcision vary only slightly. In my experience, most adult patients can comfortably undergo circumcision using only local anesthesia. Lidocaine, infiltrated at the base of the penis, provides good anesthesia to the entire penis. Sedation is occasionally used, primarily to decrease patient anxiety.
After removing the foreskin and controlling any bleeding, I prefer to close the incision with dissolvable sutures. A dressing is optional but is generally applied to the penis. If the dressing doesn’t fall off, it can be removed after 2 days. Antibiotic ointment (Neosporin) is applied twice daily to the incision after the dressing is off and until the sutures fall out (1-2 weeks).
Discomfort during the first week following circumcision is moderate and generally requires oral pain medications. Erections are uncomfortable and intercourse is prohibited for about a month.
Bleeding into the penis and infection along the incision are the most common complications of circumcision. Incomplete healing and small open areas can occur. These problems generally resolve completely with time. There is some risk that too little or too much foreskin could be removed. A perfect result can be difficult or impossible in obese patients with a receded penis. Surgeon experience is important.
The primary consideration when choosing to have a vasectomy is the certainty that future reproduction is not desired. While vasectomy reversal is possible, it is a complicated and expensive undertaking. Results of vasectomy reversal, measured by a live healthy baby, are around 70%. While not a popular topic for discussion, the most common reason to request vasectomy reversal is divorce and the most common reason for unwanted pregnancy following vasectomy is infidelity.
Vasectomy technique is straight forward with minor variations based on surgeon preference. I prefer to use only dissolvable material to tie off the ends of the vas and to suture a layer of tissue between the cut ends of the vas (fascial interposition). I avoid cautery because it can increase tissue injury. I use 2 small incisions rather than one because this approach decreases the risk of error. The “no scalpel vasectomy” has been marketed, but I consider the technique to be inferior. This technique requires that the surgeon tear the scrotal skin, and I consider a surgical incision to be less damaging to the tissues.
Complications of vasectomy are infrequent and minor. The risk varies with the skill of the surgeon. Failure can occur if the ends of the vas grow back together (recanalization). Using fascial interposition, failure has occurred in less than 1 per 1000 patients in my experience. Significant bleeding or infection is rare, but minor bleeding and infected skin sutures are relatively common and resolve without great difficulty. Persistent testicular discomfort and mild inflammation of the epididymis from congestion probably occur more commonly than most urologists are aware. The discomfort is generally mild and usually requires no specific treatment.
The need for sedation during vasectomy varies with the skill of the surgeon. In my hands, vasectomy is a 15 minute procedure that can easily be accomplished with local anesthesia and without sedation. While many patients have an understandable degree of anxiety, this is manageable and resolves when it becomes clear that things are proceeding smoothly and without much discomfort.
If you are considering vasectomy, I will be happy to discuss the procedure with you and your partner. If you choose to have a vasectomy, you can be reassured that I have the experience of performing several thousand vasectomies with excellent patient satisfaction and consistent results.
Advanced and Complicated Procedures
Medical interventions have become increasingly complex and specialized. With my experience in developing a large urology group practice in Ohio, I understand that quality and superior outcomes result from talent, focused knowledge, and extensive experience. It’s impossible for a single individual to provide high quality in all areas of urology.
Routine procedures can be provided locally without compromising quality. Repeated studies have confirmed that outcomes from more complex interventions are substantially better and complications are fewer when these treatments are performed in centers of excellence by high volume and specialized providers.
By maintaining relationships with specialized providers and maintaining awareness of capabilities in different centers of excellence, I’m able to direct patients to the best physicians for different treatments. Additionally, we coordinate care to provide preoperative and postoperative care locally when possible.