Effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia.

PURPOSE: We tested the effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia (BPH) via a randomized, placebo controlled trial. MATERIALS AND METHODS: We randomized 44 men 45 to 80 years old with symptomatic BPH into a trial of a saw palmetto herbal blend versus placebo. End points included routine clinical measures (symptom score, uroflowmetry and post-void residual urine volume), blood chemistry studies (prostate specific antigen, sex hormones and multiphasic analysis), prostate volumetrics by magnetic resonance imaging, and prostate biopsy for zonal tissue morphometry and semiquantitative histology studies. RESULTS: Saw palmetto herbal blend and placebo groups had improved clinical parameters with a slight advantage in the saw palmetto group (not statistically significant). Neither prostate specific antigen nor prostate volume changed from baseline. Prostate epithelial contraction was noted, especially in the transition zone, where percent epithelium decreased from 17.8% at baseline to 10.7% after 6 months of saw palmetto herbal blend (p <0.01). Histological studies showed that the percent of atrophic glands increased from 25. 2% to 40.9% after treatment with saw palmetto herbal blend (p <0.01). The mechanism of action appeared to be nonhormonal but it was not identified by tissue studies of apoptosis, cellular proliferation, angiogenesis, growth factors or androgen receptor expression. We noted no adverse effects of saw palmetto herbal blend. When the study was no longer blinded, 41 men elected to continue therapy in an open label extension. CONCLUSIONS: Saw palmetto herbal blend appears to be a safe, highly desirable option for men with moderately symptomatic BPH. The secondary outcome measures of clinical effect in our study were only slightly better for saw palmetto herbal blend than placebo (not statistically significant). However, saw palmetto herbal blend therapy was associated with epithelial contraction, especially in the transition zone (p <0.01), indicating a possible mechanism of action underlying the clinical significance detected in other studies.

Use of a shape-memory alloy (nitinol) in a removable prostate stent.

An easily removable prostate stent would be useful in various clinical situations but is not currently available. Thus, we studied the safety, tolerability, and ease of removal of a nitinol (nickel-titanium alloy) prostate stent in 10 men with symptomatic benign prostatic hyperplasia. The circular-coil stent becomes hourglass in shape following deployment, with the narrowest diameter approximately 35F. A working hypothesis was that the temperature-sensitive shape memory of nitinol would allow for its easy removal vis-à-vis other available stents. Using several modifications of a prototype insertion device, we found that the nitinol stents were easily inserted, retained their shape during retention periods of 1 to 4 weeks, caused no gross tissue reaction, and were removed easily with gentle traction after in situ cooling with iced saline lavage. Stent migration was observed in two patients, but otherwise, the stents were well tolerated. Nitinol prostate stents appear to fulfill a theoretical promise of being biologically inert, "superelastic," and pliable when cooled, allowing for easy removal. Further clinical investigation appears warranted.

Long-term effects of finasteride on prostate tissue composition.

OBJECTIVES: To determine the long-term effects of finasteride treatment on prostate tissue composition; to relate these effects to clinical outcomes; and to test the hypothesis that finasteride exerts a selective or preferential action on the transition zone. METHODS: Nineteen men with symptomatic benign prostatic hyperplasia (BPH) who completed a 6-month double-blind trial of finasteride were enrolled in a 24-month open-label extension study of drug responders. Magnetic resonance imaging and prostate biopsy for morphometric analysis were performed together 70 times: at baseline (n = 19), after treatment periods of intermediate duration (6 to 18 months, n = 32), and after long-term drug treatment (24 to 30 months, n = 19). At baseline, prostate volume averaged 51 cc, of which 57% was transition zone. RESULTS: Decreases in symptom score, dihydrotestosterone and prostate-specific antigen levels, and prostate volume occurred at 6 months (P <0.01), stabilized, and were maintained without further long-term decreases. Prostate epithelium contracted progressively from baseline (19.2% tissue composition; 6.0-cc volume; 3.2 stroma/epithelial ratio) to intermediate (12.5%, 3.3 cc, and 5.6, respectively) to long-term treatment (6.4%, 2.0 cc, and 17.4, respectively, P <0.01 for all). Percent epithelial contraction was similar in the peripheral and transition zones (P = NS). The transition zone remained a relatively constant proportion (53% to 58%) of whole-prostate volume from baseline to long-term observation. CONCLUSIONS: Long-term finasteride treatment (24 to 30 months) results in a marked involution of the prostate epithelium, which continues to progress for many months after clinical effects stabilize. The effect on the epithelium is similar in the peripheral and transition zones for both morphometric and volumetric changes. Progressive contraction of the prostate epithelium appears to constitute the underlying mechanism for sustained action of finasteride.

Treatment of erectile dysfunction with sildenafil.

OBJECTIVES: To determine the efficacy of sildenafil for the treatment of erectile dysfunction (ED) in a clinical practice setting; to evaluate the correlation between patient and partner perceptions of treatment outcomes; and to assess the relation between the severity of ED and response to treatment. METHODS: Among the first 100 men to receive sildenafil in a urology practice setting, 74 (mean + SD age 64+/-11 years) completed a validated sexual function questionnaire (International Index of Erectile Function [IIEF]) before and after a 4 to 6-week treatment period. A modified version of the same questionnaire was independently completed by partners. ED was categorized into a severity class of I to IV. RESULTS: Sildenafil treatment improved erections by 71% to 95%, according to responses in key IIEF questions 3 and 4. Overall, 57 (77%) of 74 patients desired to continue treatment after the test period. Patient score on the IIEF was correlated with partner score on the modified questionnaire before and after treatment (r = 0.67 to 0.81, P <0.01). IIEF scores were reflected in a simple severity classification system. Men with the best preservation of erections (severity class I) exhibited the best responses to sildenafil, whereas men with no erections (severity class IV) were much less likely to respond to the drug and desire continuation of treatment (P <0.01). Patients with a radical prostatectomy were relatively refractory to sildenafil, except for 2 of 5 who had undergone a nerve-sparing operation. CONCLUSIONS: In clinical practice, sildenafil is an effective treatment of ED, according to partner-validated questionnaire responses; and the results of treatment are predictable with an ED severity classification system.

Three-dimensional ultrasound device for rapid determination of bladder volume.

OBJECTIVES: We sought to assess the accuracy, reliability, and clinical utility of the noninvasive determination of bladder volume using an automated, compact three-dimensional (3-D) ultrasound device. METHODS: We prospectively tested 249 adult outpatients for accuracy (n = 182), by comparing scan versus catheter volumes, or reliability (n = 67), by comparing the scan readings of two independent observers. Two models of the bladder scan device were tested (BVI-2500, 1994 and 1995 models). RESULTS: Scan and catheter volumes were correlated (y = 1.02x + 12.6, R2 = 0.90, P < 0.001) across a range of zero to 1015 cc, regardless of which machine model was used. Scan volume underestimated catheter volume by an average of 10 cc in men and 20 cc in women. If a scan-predicted volume of 100 cc or greater were used as a cutpoint for clinical importance, the device exhibited a sensitivity of 97%, a specificity of 91%, and an overall accuracy of 94%. These results were not affected by age, gender, height, weight, diagnosis, uterine presence/prostate size, or user experience. The two observers, one a graduate physician and the other a college student, achieved essentially the same volume determinations (y = 0.96x + 0.13, R2 = 0.90, P < 0.001). CONCLUSIONS: Volume determinations obtained with the bladder scan device are accurate and reliable in adult outpatients. A special technician is not required. These results may be attributable to use of automated planimetry and 3-D volumetry, rather than a fixed geometric formula, to custom measure each bladder shape.