HHS CLINICAL PRACTICE GUIDELINES ON BPH WILL BE READY BY AUTUMN; UROLOGY ASSOCIATION STUDY/GUIDELINES INTENDED TO SETTLE DEBATE OVER BPH TREATMENTS

The first draft of federally sponsored clinical guidelines for the treatment of benign prostatic hyperplasia should be complete by this fall, John McConnell, associate professor or urology at the University of Texas, announced at the annual American Urological Association meeting held June 1-5 in Toronto. The guidelines, commissioned 14 months ago by Health & Human Services' Agency for Health Care Policy Research, are designed to help urologists and their patients make "informed clinical judgments based on the benefits and risks involved in various BPH therapies" and diagnostic procedures, McConnell said. The current version of the guidelines addresses only the four "treatment modalities" that are already commercially available for BPH: 1) transurethral prostatectomy (also known as prostate excision or TURP) 2) balloon dilatation; 3) alpha blocker therapy with Abbott's Hytrin (terazosin); and 4) "watchful waiting" (no treatment). However, other therapies such as Merck's Proscar (finasteride) and Pfizer's alpha blocker Cardura (doxazosin) may be included once they become available to physicians in a clinical setting. In the forthcoming AHCPR document, each of the four treatment modalities is classified as a treatment "standard," a treatment "guideline," or a treatment "option" for a given clinical situation. A standard is "something that we would all do under a certain circumstances," Winston Mebust, MD, of the AUA's Practice Parameters, Guidelines and Standards Committee explained. A guideline is "something that most of us would do under certain circumstances, because the benefits are greater than the harms" he continued, "and an option is where it is not clear that one procedure or diagnostic modality is much different from another as far as harms and benefits are concerned." For the majority of treatment situations, including the treatment of moderate and severe BPH, the AHCPR document presents urologists with only a "guideline" recommending that they fully inform their patients about all of the available treatment options without promoting one therapeutic approach over another. "We want to make the patient a major player," in determining his own therapy, commented McConnell, who chairs the AUA/AHCPR committee that is drafting the guidelines. "This is necessary for a disease like BPH because patients vary dramatically in their willingness to tolerate symptoms and also in their willingness to take on risks, for example the risk to take on surgery to alleviate symptoms." There are only two "standards," or treatment mandates, included in the proposed guidelines. In the treatment of mild BPH, characterized by slight discomfort and relatively few symptoms, the "standard" is "watchful waiting," and in the treatment of complete urinary retention the "standard" is emergency surgery. Mebust explained that the purpose of the guidelines is to help physicians make choices in an atmosphere of increasing confusion and debate about the best ways to treat BPH. For almost a century TURP has been the "gold standard" of BPH therapy. However, Mebust explained, recent events have changed the clinicians' perception of his options, including: studies from the late 1980s suggesting that there may be a slightly increased risk of cardiac death following surgery; decreasing Medicare coverage rates for TURP; and the advent of new drugs like Hytrin and Proscar. To provide more information about the various unknowns in BPH treatment, the AUA in October 1990 began its own 3,300-patient randomized, placebo-controlled multicenter trial to compare the efficacy of alpha blocker therapy, prostate surgery, watchful waiting, and balloon dilatation. As with the guidelines, Proscar currently is not included in the study protocol; but a Proscar arm is expected to be added as soon as the drug becomes commercially available. Data from the five-year AUA study will be used by the AHCPR committee to continually refine the clinical guidelines and keep them up to date with the latest information about treatment outcomes, guidelines committee member Mike Barry, MD, explained.