H. Logan Holtgrewe

The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia

Background Finasteride is known to improve urinary symptoms in men with benign prostatic hyperplasia, but the extent to which the benefit is sustained and whether finasteride reduces the incidence of related events, including the need for surgery and the development of acute urinary retention, are not known. Methods In this double-blind, randomized, placebo-controlled trial, we studied 3040 men with moderate-to-severe urinary symptoms and enlarged prostate glands who were treated daily with 5 mg of finasteride or placebo for four years. Symptom scores (on a scale of 1 to 34), urinary flow rates, and the occurrence of outcome events were assessed every four months in 3016 men. Prostate volume was measured in a subgroup of the men. Complete data on outcomes were available for 2760 men. Results During the four-year study period, 152 of the 1503 men in the placebo group (10 percent) and 69 of the 1513 men in the finasteride group (5 percent) underwent surgery for benign prostatic hyperplasia (reduction in risk with finasteride, 55 percent; 95 percent confidence interval, 41 to 65 percent). Acute urinary retention developed in 99 men (7 percent) in the placebo group and 42 men (3 percent) in the finasteride group (reduction in risk with finasteride, 57 percent; 95 percent confidence interval, 40 to 69 percent). Among the men who completed the study, the mean decreases in the symptom score were 3.3 in the finasteride group and 1.3 in the placebo group (P<0.001). Treatment with finasteride also significantly improved urinary flow rates and reduced prostate volume (P<0.001). Conclusions Among men with symptoms of urinary obstruction and prostatic enlargement, treatment with finasteride for four years reduces symptoms and prostate volume, increases the urinary flow rate, and reduces the probability of surgery and acute urinary retention.

Relationship of Symptoms of Prostatism to Commonly Used Physiological and Anatomical Measures of the Severity of Benign Prostatic Hyperplasia

In previous studies the severity of symptoms of prostatism in men with benign prostatic hyperplasia have not correlated well with prostate size, degree of bladder trabeculation, uroflowmetry or post-void residual volume. As part of a prospective cohort study of benign prostatic hyperplasia treatment effectiveness in 4 university-based urology practices, we correlated symptom severity and these commonly used measures of disease severity. Symptom severity was quantified using the American Urological Association symptom index. Analyses were based on 198 outpatients completing a standardized evaluation (84 of these men have completed 6 months of followup after treatment with prostatectomy, balloon dilation, terazosin or watchful waiting). At baseline, symptom severity was not correlated with uroflowmetry, post-void residual, prostate size and degree of bladder trabeculation. However, symptom severity was much more strongly related to overall health status than the other measures. Reduction in symptoms with treatment did correlate with improvements in uroflowmetry. This poor baseline correlation with symptoms may reflect unreliability in measurement of the physiological/anatomical variables. Alternatively, these parameters may be measuring different pathophysiological phenomena.

Urinary Retention in Patients with BPH Treated with Finasteride or Placebo over 4 Years

Objectives: Knowledge regarding the incidence and prevalence of acute urinary retention and the ultimate outcome is very limited. The purpose of the present analysis was to document the natural history and outcomes of acute urinary retention (AUR) further specified as being either precipitated or spontaneous, and to evaluate the potential benefit of finasteride therapy.Materials and Methods: Three thousand and forty men with moderate to severe symptoms of BPH and enlarged prostate glands by digital rectal examination were enrolled into the 4–year placebo–controlled PLESS trial and were evaluated for occurrences of AUR and BPH–related surgery. Men in the study were seen every 4 months; discontinued patients were followed up 6 months after discontinuation and again at the end of the 4–year trial. Complete 4–year data on outcomes (occurrence of AUR or BPH–related surgery) was available for 92% of the enrolled subjects in each treatment group. An endpoint committee, blinded to treatment group and center, reviewed and categorized all study–related documentation relating to retention and surgery.Results: Over the 4–year period, 99 of 1,503 placebo–treated patients (6.6%) experienced one or more episodes of AUR in comparison with 42 or 1,513 finasteride–treated patients (2.8%; p<0.001). Approximately half of the episodes of retention were spontaneous and clearly BPH–related, while the other episodes were precipitated by another factor (PAUR). After spontaneous AUR, subsequent surgery was performed in 39 of 52 (75%) placebo–treated patients versus 8 of 20 (40%) finasteride–treated patients (p = 0.01). BPH–related surgery was less common in men who had a prior episode of PAUR (26% in the placebo group and 14% in the finasteride group).Conclusion: There is a continual risk of spontaneous and precipitated acute urinary retention in men with moderate to severe lower urinary tract symptoms and an enlarged prostate gland. Fewer patients who developed precipitated AUR than spontaneous AUR go on to need subsequent BPH–related surgery. Significantly fewer finasteride–than placebo–treated patients developed AUR, and among those men, fewer ultimately needed BPH–related surgery.

1997 American urological association gallup survey : Changes in diagnosis and management of prostate cancer and benign prostatic hyperplasia, and other practice trends from 1994 to 1997

PURPOSE The American Urological Association first commissioned the Gallup Organization to conduct a study to assess urologist practice patterns in 1992. We present the results of the 1997 survey, the sixth consecutive Gallup survey performed for the Association. MATERIALS AND METHODS A random sample of 502 American urologists who had completed urological residency and practiced at least 20 hours weekly in 1996 was interviewed by telephone in February and March 1997. RESULTS Emerging trends showed significant changes since 1994 in how urologists diagnosed and treated prostate cancer. The survey revealed a significant change in the tests routinely ordered to stage newly diagnosed prostate cancer and for diagnostic evaluation of patients with benign prostatic hyperplasia. CONCLUSIONS Urologists are becoming more cost conscious and effective in ordering pretreatment testing. Urologists are becoming more oriented toward medical treatment for the management of benign prostatic hyperplasia, and less laser surgery is being performed.

Guidance for Clinical Investigations of Devices Used for the Treatment of Benign Prostatic Hyperplasia

For nearly a century surgery was the only therapeutic option in the treatment of obstructive uropathy induced by benign prostatic hyperplasia (BPH). The last few years have witnessed an array of new emerging strategies of management-pharmacological, hormonal, thermal and device. Much of the present existing data concerning the outcomes of these new therapies remain unpublished and are of relatively short followup intervals, and few of these studies use common or comparable protocols. This plethora of study methodology makes comparison of these therapies, with each other and with existing therapies, difficult. However, some of these therapies are being advocated and are in current use nationwide, while others await introduction

Comparison of the efficacy and safety of finasteride in older versus younger men with benign prostatic hyperplasia.

OBJECTIVES To compare the efficacy and safety of finasteride 5 mg in older (65 years old or older) versus younger (45 to younger than 65 years old) men with benign prostatic hyperplasia (BPH). METHODS The Proscar Long-Term Efficacy and Safety Study (PLESS) was a 4-year, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of finasteride 5 mg in 3040 men 45 to 78 years old with symptomatic BPH, enlarged prostates, and no evidence of prostate cancer. The endpoints included urinary symptoms, prostate volume, occurrence of acute urinary retention and/or BPH-related surgery, and safety. RESULTS In both age cohorts, finasteride treatment led to a 51% reduction (P <0.001) in the relative risk for acute urinary retention and/or BPH-related surgery, a significant (P <0.001) and durable improvement in symptom score, and a significant (P <0.001) and sustained reduction in prostate volume. Within each age cohort, no significant differences were found between the placebo and finasteride-treated patients in the incidence of cardiovascular adverse events. Significant differences were evident between the placebo and finasteride groups in the incidence of the typical, known, drug-related adverse events, but no specific differences were associated with age. No drug interactions of clinical importance were observed in the finasteride-treated patients. CONCLUSIONS The present analysis from PLESS demonstrates that in both older (65 years old or older) and younger men with symptomatic BPH and enlarged prostates, finasteride is highly effective in improving symptoms and reducing prostate volume in many men and in reducing the risk of acute urinary retention and BPH-related surgery. In addition, the safety profile of finasteride in both older and younger men is similar and no drug interactions of clinical importance were observed.

Indications for treatment of benign prostatic hyperplasia: The American Urological Association Study

Background. In 1990, a pilot study was begun that evaluated benign prostatic hyperplasia (BPH) at five clinical institutions. Data management and coordination of this study was performed at the Medical Practices Evaluation Center at Massachusetts General Hospital. Because of decreased patient enrollment, one institution was dropped. This was a randomized, prospective, clinical study that provided an initial overview of the trial and a rationale for the project.

EDITORIAL: SURGICAL MANAGEMENT OF BENIGN PROSTATIC HYPERPLASIA IN 2001—A PAUSE FOR THOUGHT

fluid did appear to be absorbed in past and present smokers in the Hahn study. Why? The author, who has a substantial body of previous literature on the topic of irrigating fluid absorption during prostatic resection, postulates that vascular endothelial growth factor is released in increased amounts in the prostate of smokers due to the ischemic cardiovascular effects of smoking. Thus, more blood vessels in the prostate increase the risk of absorption during prostatic resection. Furthermore, the author suggests that increased numbers of prostatic blood vessels allow the gland to enlarge, thus explaining why severe urological symptoms develop more often in smokers who increasingly undergo prostatic surgery. This result is interesting if true. However, it is difficult not to believe that the biggest factor causing irrigation fluid absorption during transurethral prostatic resection is surgeon technique and expertise. This factor is especially true with resecting large prostates. Chacko et al (page 166) found that transurethral prostatic resection was superior in all outcome parameters to laser prostate therapy in a cohort of men with preoperative acute urinary retention. Symptom improvement and uroflow rates were better, while the need for re-treatment was less in the prostatic resection group. Furthermore, the duration of post

1998 AMERICAN UROLOGICAL ASSOCIATION GALLUP SURVEY: CHANGES IN PHYSICIAN PRACTICE PATTERNS, TREATMENT OF URETERAL STONES AND IMPACT OF MANAGED CARE

PURPOSE The American Urological Association first commissioned the Gallup Organization to conduct a study to assess urologist practice patterns in 1992. We present the results of the seventh consecutive Gallup Survey performed for the Association. MATERIALS AND METHODS A random sample of 537 American urologists who completed urological residency and practiced at least 20 hours weekly in 1997 were interviewed by telephone in March 1998. Major topic areas included general demographics, practice patterns, treatment of ureteral stones and experience with managed care. RESULTS Demographic trends indicated a significant decrease in average urologist age from 49.4 years in 1992 to 46.8 in 1998. Of the urologists 99% reported that they treat ureteral stones. Managed care had an increasingly larger role in most practices, particularly in the western United States, where 73% of urologists reported that they contract with a Medicare health maintenance organization. CONCLUSIONS The average age of practicing urologists significantly decreased, which may be due to an increasing number of urologists retiring at an earlier age, although this finding is not clear. Nearly all urologists treated ureteral stones with considerable consistency. Finally, managed care appeared to have a major impact on most urologists throughout the United States.