Detection of prostatitis

Details Detection of prostatitis Detection of prostatitis

1999-11-11

2002-04-02

Nguyen, Bao-Thuy L. (Department: 1641)

Chemistry: molecular biology and microbiology

Measuring or testing process involving enzymes or...

C435S007400, C435S019000, C435S287700, C435S287900, C435S970000, C436S518000, C436S524000, C436S810000, C436S823000, C530S380000

Reexamination Certificate

active

06365340

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a device and process for detecting prostatitis.
DESCRIPTION OF THE RELATED ART
The prostate gland (or prostate) is a walnut-sized, mucous-producing organ in males that lies just below the urinary bladder. The prostate typically grows and enlarges throughout life. The only known function of the prostate is to produce a secretion that nourishes and protects the sperm during reproduction. The urethra, the canal that in most mammals discharges urine from the bladder, passes through the prostate gland. Unfortunately, this anatomical feature creates problems, often associated with difficulty in urination, as males age.
A national survey of U.S. physician visits estimated that the diagnosis of prostatitis results in 2 million office visits per year in the United States and is the most frequent diagnosis resulting in an office visit to urologists in men less than 50-years-old. Collins, M. M., et al. (1998)
J. Urol
. 159:1224-1228. Prostatitis is defined as an inflammation or infection of the prostate gland. While prostatitis may be acute, associated with systemic findings of fever, chills and rigors, most cases of prostatitis are chronic and tend to be incurable with relatively frequent recurrences despite optimal standard therapy. Chronic prostatitis (inflammation or infection of the prostate) is common to all adult men. It is associated with virtually all cases of prostate cancer and is present in every prostate biopsy regardless of other findings. Chronic prostatitis may not cause significant symptoms in many men, but in others it can be a devastating disease that severely affects the quality of life of those afflicted. It is difficult to diagnose and even more difficult to treat.
The most common symptom of chronic prostatitis is pelvic pain, followed by various voiding symptoms, impotence, and infertility. Pain from prostatitis is usually located in the groin, testicles, and penis, just above the rectum or in the suprapubic area over the bladder. Pain is frequently associated with ejaculation. Typical voiding symptoms produced by prostatitis include getting up at night to void (nocturia), frequency and urgency of urination, incomplete voiding, decreased force of the urinary stream, intermittency of the stream, and a need to push or strain to void. Impotence or erection difficulties and male infertility are also associated with prostatitis.
Conventional methods of detecting prostatitis include a digital rectal examination, midstream specimen of urine, specific culture, urine dipstick, and ejaculate culture. Other methods include the AUA Symptom Score, which is a survey that was drafted by the American Urologists Association and was validated in 1996. It evaluates a man's voiding abilities. Symptom Score survey includes questions on nocturia, frequency, intermittency, incomplete elimination, stream size, urgency, and the need to strain. Respondents answer seven questions about the severity of symptoms. Respondents indicate the frequency of the events, with each frequency having an assigned score, and a diagnosis is made.
Still another method is the prostate specific antigen (PSA) test, which is a blood test that can be used to detect prostatitis. PSA is a protein substance produced by certain cells in the prostate gland. A very small amount of PSA escapes into the blood stream. Thus, PSA can be tested in the blood. Because the amount of PSA in the blood is very low, detection of it requires a very sensitive monoclonal antibody technique.
Still yet another test is one that examines expressed prostatic secretion (EPS), which is a secretion, not a body fluid. Traditionally, EPS was tested through a microscopic examination of the EPS. The prostatic secretion is obtained by gentle massage of the prostate during the digital rectal examination. When the secretion is examined under the microscope, a finding of more than 10 white blood cells per high powered field (WBCS/HPF) is considered definitive proof of inflammation and prostatitis.
While all of these tests are available, Nickel, et al. report that only 18% of primary care physicians (PCPs) and 41% of urologists said that they employed any type of specific prostate tests. Nickel, et al. (1998)
Urology
52(5) 797-802. Nickel, et al. conclude from a survey of PCPs and urologists that there is widespread frustration, discomfort, and a lack of confidence in their perceived ability to manage prostatitis. Specifically, physicians have expressed a high degree of frustration and unhappiness in dealing with prostatitis, which was driven by a lack of confidence and comfort in their ability to accurately diagnose and subsequently rationalize treatment of prostatitis. The surveyed physicians expressed a desire for a simpler and clearer diagnostic guidelines.
Simpler and clearer diagnostic guidelines are provided by the invention described herein. The invention includes a method for detecting prostatitis using a device, such as a dipstick, to test for white blood cells in EPS. Dipsticks are currently used to test for multiple analytes, such as glucose and protein. For example, a dipstick that detects neutrophil defensins to diagnose reproductive tract inflammation and preeclampsia is described in U.S. Pat. No. 5,972,594 to Heine.
Dipsticks and related components that detect leukocytes and leukocyte enzymes in body fluids have been patented. For example, U.S. Pat. No.4,758,508 to Schnabel, et al. describes an agent and a method for detecting esterolytic and/or proteolytic enzymes in body fluids. U.S. Pat. No. 4,637,979 to Skjold, et al. describes a composition and test device for determining the presence of leukocytes in test samples including body fluids such as urine. U.S. Pat. No. 4,645,842 describes pyrrole compounds, and U.S. Pat. No. 4,704,460 (both to Corey) describes novel compounds for detecting the presence of hydrolytic analytes including leukocytes, esterase, and protease, in a test sample, including urine. U.S. Pat. No. 4,774,340 to Corey describes a method for preparing 3-hydroxy pyrroles and esters thereof, which are used to test samples including urine. A composition and test device for determining the presence of leukocytes, esterase, and protease in a body fluid including urine is described in U.S. Pat. No. 4,657,855 to Corey, et al. A method for determining the concentration of white blood cells in urine or other biological fluid is described in U.S. Pat. No. 5,663,044 to Noffsinger, et al. A method for preparing an ester used to detect leukocyte cells, esterase, and protease in body fluids such as urine is described in U.S. Pat. No. 4,716,236 to Ward, et al. All of these patents, which are incorporated herein by reference, correlate an abnormally high level of leukocytes in a patient's urine with the possible indication of pathological conditions such as kidney or urogenital tract infection or other dysfunction.
However, none of the above-noted approaches provides a rapid and economical method of detecting prostatitis. More particularly, none of these use EPS as a test sample. Such a method, described herein, provides a rapid and economical method for detecting prostatitis.
SUMMARY OF THE INVENTION
A principal aim of the invention is to provide a method for detecting prostatitis that includes using a device, such as a dipstick, to test expressed prostatic secretion (EPS).
A further aim of the present invention is to provide a device, such as a dipstick, for detecting prostatitis that includes an indication of the presence or absence of prostatitis.
In short, the invention described herein is directed to a method of detecting prostatitis comprising obtaining an expressed prostatic secretion from a patient; contacting a device having diagnostic test reagents to the expressed prostatic secretion, the diagnostic test reagents reacting with the expressed prostatic secretion to produce a change in the device; reading the change in the device to produce a positive or negative experimental test result, wherein the experimental test result is positive when the experimenta

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