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A prostate-specific antigen (PSA) test measures the level of PSA in the blood to screen for prostate cancer. PSA is a substance made mostly by the prostate that may be found in an increased amount in the blood of men who have prostate cancer. While an elevated PSA may be a sign of prostate cancer, PSA levels can also be high in men who have an infection or inflammation of the prostate or benign prostatic hyperplasia (BPH is an enlarged, but noncancerous, prostate).
Hypospadias is a male birth defect in which the opening of the tube that carries urine from the body (urethra) develops abnormally, usually on the underside of the penis. There are four types of hypospadias, based on where the urethral opening occurs. They are: Glandular hypospadias, coronal hypospadias, penile shaft hypospadias and perineal hypospadias.
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A piece of tissue is obtained and sent to a pathologist to determine if cancer is present. In the urology office we commonly perform prostate biopsies. These are performed with ultrasound guidance. The rectum is locally anesthetized before the urologist takes several cores of prostate tissue with a biopsy needle. Other biopsies, such as those from the bladder, are usually performed in the hospital.
Several blood tests are useful to the urologist in order to determine the health of the urinary system. Some of the more commonly performed tests are the PSA, creatinine, BUN and testosterone.
The PSA is a test that helps to detect prostate cancer. The creatinine and BUN help assess kidney function. Testosterone is important when evaluating male erectile dysfunction. Several different blood tests are performed when evaluating infertility.
CT stands for "computerized tomography" and is an x-ray technique that is much more sensitive than regular x-ray. It helps diagnose a variety of urologic disorders, such as stones, tumors and cysts.
A cystoscopy is a procedure that the urologist uses to look inside the patient's bladder. When it is done in the office, a local anesthetic is used to numb the urethra. The urologist inserts a small telescope-like instrument into the bladder and fills the bladder with some water while examining the urethra, the prostate in men and the inside of the bladder. Bladder tumors, other abnormalities of the bladder wall and stones are some of the conditions that can be observed with cystoscopy.
Cytology is a test used to look for cancer cells in the urine. A urine specimen is sent to a lab for the pathologist to examine for the abnormal cells.
Digital rectal exam (DRE) is an exam of the prostate gland. The urologist inserts a gloved and lubricated finger into the rectum and feels the prostate. This exam is used to measure the size and feel the texture of the prostate. Any abnormal nodule or firmness can be felt and a decision can be made about whether an ultrasound and possible biopsy is needed.
After a patient urinates, a brief ultrasound study of the bladder can show how much urine is left in the bladder. It is often important to know about this residual urine following surgery or when evaluating the patient's bladder for obstruction, especially from an enlarged prostate.
Prostate specific antigen is a substance released from the prostate tissue and can be measured by a simple blood test. Elevated levels of the antigen in the blood can indicate prostate cancer, but also can indicate inflammation of the prostate.
Semen analysis is done as a first step in determining male infertility. A laboratory technician examines the semen sample for the presence of sperm and the motility and quality of the sperm.
A semen analysis is also done after a vasectomy to determine if the procedure has successfully eliminated sperm from the ejaculate.
Urinary tract stones are analyzed in a laboratory after they are either passed by the patient or removed surgically. The analysis of the stone composition allows the urologist to determine if future stones can be possibly prevented with medication or with dietary changes.
Ultrasound is an imaging tool that is often used in the urology office to examine the kidneys, the bladder, the prostate and the testicles. It helps the urologist diagnose many conditions such as tumors, cysts, stones, kidney enlargement and abnormal movement of the bladder and urethra.
A urine flow study determines the rate and the force of urination as it measures the length of time it takes a patient to urinate. An abnormal flow study may indicate obstruction, as from an enlarged prostate, or poor bladder tone.
There are many tests performed on urine that help the urologist diagnose disease or monitor treatment. Some of the more commonly performed tests are a urinalysis, urine culture and sensitivity and 24-hour urine tests.
Urinalysis is performed in the office using a dipstick that detects and measures blood, sugar, protein and other substances in the urine. A microscopic exam of the urine finds blood cells, crystals, bacteria, yeast and other things that may be present.
Urine cultures are performed in the laboratory when a urinary tract infection is suspected. The culture is incubated for several hours and then any bacterial growth is examined by the lab tech to determine what bacteria is causing the infection. Sensitivity studies are performed on the culture growth to determine which antibiotics will kill the bacteria and clear up the infection.
24-hour urine tests are performed to detect many disease processes. The patient collects all urine expelled for 24 hours in a large bottle. The lab analyzes the urine for abnormal levels of the many substances that are filtered from the bloodstream by the kidneys.
Urodynamic testing is done to assess bladder function by measuring muscle tone and nerve activity during the process of filling the bladder with water and emptying the bladder during urination. The testing can be done in the office or in the x-ray department of a hospital. Pressure-measuring catheters are inserted into the bladder and rectum and small electrodes may be attached to the skin.
Many different x-ray studies may be prescribed to diagnose conditions of the urinary tract. Some of the more commonly performed x-ray studies are a KUB, an IVP and a VCUG. These x-rays may be performed in the office or in another radiology facility.
KUB is a simple x-ray of the kidneys, ureters and bladder.
IVP stands for intravenous pyelogram and is a series of x-rays taken after contrast (dye) is injected into the bloodstream. The contrast helps define the structures of the urinary tract as the urologist looks for stones, tumors or other conditions and abnormalities.
VCUG (Voiding Cystourethrogram) is done to examine the bladder and urethra while the bladder fills and empties. A radiopaque liquid (that can be seen on x-ray) is placed in the bladder through a catheter. The bladder is filled until the patient urinates. Radiographs (x-rays) are usually taken before, during, and after voiding. This test can reveal abnormalities of the inside of the urethra and bladder. The test can also determine whether the flow of urine is normal when the bladder empties.
Drugs and medical devices must undergo extensive testing before they can be approved by the Food and Drug Administration (FDA). Before testing in people begins, laboratory research is done, and typically involves years of experiments in animal and human tissue. If this stage of testing is successful, the manufacturer may apply to the FDA to begin clinical trials.
Clinical trials usually take place over several years and involve hundreds to thousands of volunteers. The results of the clinical trials will provide the manufacturer and the FDA with answers to two important questions: Is the product safe? Is it effective?
A clinical trial may last a few weeks or several years. A study may be "open" (both the physician and the volunteer know what drug is being used) or it may be "blinded" (neither the physician nor the volunteer knows which of the two drugs is being used).
Blinded studies often involve the use of a "placebo" (a substance with no therapeutic value) so that the treatment results between people using the test drug and people using only the placebo can be compared.
A volunteer will always be told if a clinical trial involves a placebo. Usually placebos are used as an addition to other approved drugs that would normally be given to patients for treatment of their disease.
Is Clinical Research Safe?
There are several safeguards for volunteer protection built into the clinical trial process. Clinical trials follow strict FDA-approved plans called 'protocols.' The protocol provides the physician with information on how the product must be used, what safety tests will be performed, and how often the volunteer must come to the clinic during the trial.
The FDA also requires the volunteer to be given a detailed document called an 'informed consent.' The informed consent tells the volunteer about the study, including:
A volunteer has the right to know as much information about the trial as is necessary to make a decision to participate. Therefore, volunteers are encouraged to ask the doctor and the research staff questions or to provide more details.
Review of the protocol by an Institutional Review Board (IRB) is another safeguard. The IRB, which is composed of physicians, scientists and lay people, helps determine that the study poses no unnecessary risks to the volunteer.
Should I Participate?
People participate in clinical trials for many reasons. Volunteers can gain access to promising drugs and medical devices long before they are approved for the marketplace. Also, in drug trials, the product is typically supplied to the volunteer at no charge. And, as stated above, there is usually no charge for study-related exams, tests and procedures.
Some people volunteer because they enjoy being at the forefront of new technologies. Others participate for humanitarian reasons - helping to gather information on diseases, drugs and medical devices that could potentially impact the lives of millions of people. Each person must decide if enrolling in a clinical study is right for him or her.
Who Pays For Clinical Research?
Clinical research is funded by both the government (through the National Institutes of Health) and by private drug and medical device manufacturers. The institution paying for the research is called the 'sponsor.' The sponsor hires physicians to conduct clinical trials who are usually paid on a per-patient basis. The sponsor pays the physician to gather information about the drug or device by performing study-related exams, tests and procedures.
A volunteer's usual and customary medical exams, tests and procedures not related to the study are paid for by the volunteer or other third-party payer (such as an HMO, insurance company or Medicare), just as they would be if the volunteer was not in a clinical trial. All tests, procedures and exams that are being done just for the trial and are not part of normal treatment, are paid for by the sponsor.
Your doctor will be glad to discuss participation in clinical trials and answer any questions you may have. He or she may refer you to the doctor in charge of a study, called the 'principal investigator.' You can also call the Urology Associates of North Texas Clinical Research department, which is staffed by nurses and other healthcare professionals, at (817) 465-8715 ext. 108 during normal business hours. The Clinical Research department can give you information about current studies or you may register to be notified about future clinical trials. Of course, you are under no obligation to participate.
If you have access to a computer and the Internet, you can find thousands of websites providing information on clinical research, pharmaceutical and medical device manufacturers, and the FDA.
Contact the Clinical Research Department at firstname.lastname@example.org.
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