Prostate cancer, BPH and urinary incontinence were major interest areas at the European Congress of Urology in Paris. Developments in clinical diagnostic differentiation between benign prostate hyperplasia (BPH) and prostate cancer potentially will reduce numbers of false positives and reduce the need for confirmatory biopsies. Improved microwave thermotherapy can improve non-surgical prostate treatment significantly, and a number of recently launched stress urinary incontinence devices hopefully will improve the quality of life substantially for a large number of disadvantaged women. Lastly, a new Internet service may be of interest to companies producing urological devices and seeking a new way to contact urologists. Fecal Collection - Urological Collection Devices, Drainable Fecal Collectors, Bard, Invacare, Medical supplies, Home health care supply

New markers for prostate cancer

Prostate cancer is the second-most-frequent cancer in European men, with an average incidence of 35 per 100,000 males and a median age of 73. Some 95% of diagnoses are made between the ages of 57 and 88. Since the early stages of prostate cancer are often asymptomatic, the methods of diagnosis available become particularly important. Until recently, there have been three main screening methodologies:

* Digital rectal examination (DRE).

* Laboratory assessment of prostate-specific antigen (PSA) in serum samples.

* Endorectal echography of the prostate (TRUS).

None of these tests in isolation can provide a sure diagnosis, and a biopsy is usually necessary to provide confirmation.

The diagnostic problem

The problem with using the prostate-specific antigen immunoassay test is that PSA exists at elevated concentrations both with prostate cancer and benign prostatic hyperplasia. On the other hand, DRE is known to miss about one-third of cancer cases. For this reason, transrectal ultrasonography (TRUS) and biopsies frequently are needed for the final diagnosis. Even then, many biopsies prove to be negative, implying that PSA and DRE results have been false positives. Improvement of laboratory blood tests clearly would provide a convenient and economic way of improving the differential diagnosis of prostate cancer and BPH.

Diagnostic solutions

As a result, a number of diagnostics suppliers have developed tests to differentiate and quantify free PSA and total PSA. PSA is a typical protease enzyme which exists as a free form and also is complexed to various inhibitors. These different forms are present in varying proportions in patients with BPH and prostate cancer. This makes possible the design of a new generation of total PSA/free PSA test kits which will measure the ratio of free to total PSA (see Table 4). The results provide a significant improvement in diagnostic specificity, reducing numbers of false positives.

Free PSA assays are available in Europe from Abbott Laboratories (Abbott Park, Illinois), for use in the IMx system; from Hybritech (San Diego, California) in its line of Tandem assays, and from CIS Bio International (Gif-sur-Yvette, France) as a radioimmunoassay. Wallac (Turku, Finland) launched at the Paris meeting its ProStatus PSA free/total assay, which uses Delfia time-resolved fluorometry to measure simultaneously from one microplate well both free and total PSA. Centocor (Leiden, the Netherlands) also has developed research dual-monoclonal enzyme immunoassays to measure free and total PSA values. Results using the Centocor PSA assays correlated very well with Hybritech's Tandem assays in a paper presented at the urology congress by Abdel-Aziz Elgamal from the Catholic University of Leuven (Leuven, Belgium).

Kim Pettersson and his group at the Department of Biotechnology, University of Turku (Turku, Finland), have investigated the measurement of human glandular Kallikrein (h[K.sub.2]), a close homologue to PSA, and the possible effect of cross-reactions with h[K.sub.2] affecting PSA assay results. They also are investigating the relevance of increasing concentration of h[K.sub.2] in some prostate cancer patients. In particular, the Turku researchers are using a range of assays developed with Wallac to measure a range of different circulating forms of h[K.sub.2] and PSA in a large group of patient serum samples.

PSA density

In the early diagnosis of prostate cancer, low PSA levels of 4 to 10 ng/ml present problems of interpretation and differentiation between BPH and cancer. A number of studies have been published proposing the calculation of prostate-specific antigen density (PSAD) as providing a better predictive value in detecting prostate cancer at intermediate PSA levels, but with contradictory results up to now. PSAD levels are calculated by comparing PSA levels with prostate volume using transrectal ultrasonography. Since PSA leakage from a benign prostate into circulating blood comes mostly from the transition zone of the prostate, groups from the Erasme University Hospital (Brussels, Belgium), the University of Vienna (Vienna, Austria) and the Miguel Servet Hospital (Zaragoza, Spain) have proposed relating serum PSA levels to the PSAD of the transition zone, rather than the complete prostate (PSAT). Initial reported results are very encouraging and Alexander Zhotta of the Department of Urology, Erasme University Hospital, commented that PSAT could become a routine tool for urologists in the prediction of prostate cancer in men with PSA of 4-10 ng/ml. PSAT is even capable of identifying a non-negligable percentage of patients with serum PSA less than 4 ng-ml, but at a high risk for prostate cancer.

Prophet without honor in his own country

Stress urinary incontinence

Most women with stress urinary incontinence (SUI) preferentially choose non-surgical treatments. These offer patients the opportunity to combat their incontinence while permitting physicians to assess effectiveness during the treatment. Since SUI is a quality-of-life issue, it is important that the patient should play an important part in choosing the degree of intervention. Table 5 shows the various levels of intervention which are implied with the use of urinary control devices available in Europe.

An estimated 13 million people in the United States are affected by urinary incontinence. The condition has serious economic, social and psychological ramifications for those it affects. Stress urinary incompetence is an underdiagnosed and under-reported problem, with patients avoiding complaining about the problem because of the shame associated with urine loss and because their primary care physicians often fail to inquire about incontinence.

About 20% of women 40 to 60 years of age and 50% to 70% of women in chronic care facilities have urinary incontinence, due primarily to SUI. Stress urinary incontinence also is common during and after pregnancy.

Recent advances in the non-surgical management of SUI, particularly in the non-institutionalized female population, have widened significantly the options for patients who prefer not to undergo surgical or pharmacological modalities and for those for whom these treatments have not been satisfactory.

In Western Europe, there are about 75,000 surgical procedures for SUI each year, with more than 90% being principal and secondary procedures including plications, suprapubic slings, urethral suspensions and levator muscle operations. The remaining 10% are mostly implantations of the AMS 800 artificial sphincter from American Medical Systems (Minnetonka, Minnesota).

Periurethral injections

Urinary control urethral inserts

Fecal Collection, Urological Collection Devices, Drainable Fecal Collectors, Bard, Invacare, Medical supplies, Home health care supply

The Autocath 100 intra-urethral device from HK Medical Technologies (San Antonio, Texas), approved by the FDA in May, has been the subject of trials at the Bristol Urological Institute (Bristol, United Kingdom), where Mark Wright has used it successfully in initial trials on 10 patients. HK Medical Technologies received the CE mark for European sales last month, with a full launch expected early in 1997. Wider use of the Autocath 100 is limited because of the need for a physician's office or clinic visit for initial fitting and subsequent removal. The Reliance urinary control insert from UroMed Corp. (Needham, Massachusetts), however, is a single-use disposable plastic device which, after initial examination and demonstration by the urologist, can readily be fitted by the patient herself. The Reliance device is a balloon-tipped insert in which the balloon is inflated after insertion, locking the device in place. An airtight valve prevents accidental deflation. It is easily deflated and removed for micturation, after which a new sterile Reliance device is inserted.

Bladder neck support

The Introl bladder neck support prosthesis developed by Johnson & Johnson Medical (Arlington, Texas) has been designed to elevate the urethrovesical junction and to mimic the effects of retropubic urethropexy. It looks like a contraceptive diaphragm with a hole in the middle to accommodate the cervix and two ridges at one end to raise the bladder neck. Periodic follow-up examinations for removal, cleaning and examination are necessary.

Adhesive patch

A recently approved adhesive patch, the Miniguard - also from UroMed - is intended to prevent leakage in women with mild to moderate SUI (SUI Grade 1/2). The small, disposable, non-invasive patch is placed externally against the urethral opening. UroMed has reported results of a five-month multicenter clinical trial where 46% of SUI patients were completely dry and 82% experienced improvement in dryness.

Urology on the Internet

A new Internet service, Uroweb, was launched at the urology congress to provide continuously updated information on all activities and programs of the European Association of Urology (EAU). The organizing agency, URO Communication (Nijmegen, the Netherlands), said Euroweb provides a wide range of new possibilities in clinical and scientific exchange. It will include a forum for EAU corporate sponsors to explain and demonstrate their interest and involvement with the global urological community. Fecal Collection, Urological Collection Devices, Drainable Fecal Collectors, Bard, Invacare, Medical supplies, Home Health Care Supply