Intralesional Injection of Hyaluronic Acid in Patients Affected With Peyronie's Disease: Preliminary Results From a Prospective, Multicenter, Pilot Study.

INTRODUCTION: Hyaluronic acid has been shown to be efficacious in decreasing scar formation, inflammation, and oxidative stress. AIM: To assess the efficacy of intralesional injection of hyaluronic acid in patients affected by Peyronie's disease. METHODS: In this prospective, single-arm, self-controlled, interventional, multicenter pilot study, 65 patients underwent a 10-week cycle of weekly intraplaque injections with hyaluronic acid (0.8% highly purified sodium salt hyaluronic acid 16 mg/2 mL; Sinovial, IBSA, Lodi, Italy). Patients were re-evaluated 2 months after the end of therapy. MAIN OUTCOME MEASURES: Plaque size (millimeters), penile curvature (degrees), International Index of Erectile Function (IIEF-5) score, visual analog scale (VAS) score for sexual satisfaction, and Patient's Global Impressions of Improvement (PGI-I) score. RESULTS: Median age was 57 years (range = 23-70). At baseline, mean plaque size was 10 mm (range = 3-30 mm), mean penile curvature was 30° (range = 0°-50°), and mean IIEF-5 score was 20 (range = 0-25), with slight to moderate erectile dysfunction (IIEF score < 21) in 36 of 65 patients (55%). A median VAS score of 6 (range = 2-10) was found. Mean follow-up was 12 months (range = 6-24 months). Statistically significant post-treatment improvements were detected for plaque size (before treatment = 10 mm [3-30 mm], after treatment = 8 mm [1-30 mm], P < .0001), penile curvature (before treatment = 30° [0°-50°], after treatment = 20° [0°-40°], P < .0001), IIEF-5 score (before treatment = 20 [11-25], after treatment = 21 [15-25], P < .0001), and VAS score (before treatment = 6 [2-10], after treatment 8 [2-10], P < .0001). After treatment, the rate of patients with an IIEF score lower than 21 decreased from 55% (36 patients) to 40% (25 patients). Overall improvement on the PGI-I questionnaire was 69%. CONCLUSION: Intralesional treatment with hyaluronic acid can improve plaque size, penile curvature, and overall sexual satisfaction and seems preferably indicated in the early (active) phase of the disease. Furthermore, it is easy to perform and well tolerated.

A randomized trial comparing tamoxifen therapy vs. tamoxifen prophylaxis in bicalutamide-induced gynecomastia.

BACKGROUND: Tamoxifen (TAM) has been shown to be active against the bicalutamide-induced breast events (BEs) gynecomastia, and breast pain in patients with prostate cancer (PC). Optimal doses and schedules are not yet established. Debate still exists about whether prophylaxis with TAM is more effective than treatment of BEs when diagnosed. The results of a randomized study comparing TAM prophylaxis vs. TAM therapy are presented. METHODS: One hundred seventy-six patients with prostate cancer (PC) who were candidates for bicalutamide monotherapy were randomized to receive TAM 20 mg daily orally within 1 month from the onset of BEs (arm A) vs. TAM 10 mg daily starting simultaneously with bicalutamide (arm B). TAM was administered for up to 1 year. BEs were evaluated by a self-administered visual analogue scale. Neither ultrasonography nor calipers were used to measure the degree of gynecomastia. RESULTS: In arm A, BEs showed a prevalence, increasing with time up to 78.3%. After therapy with TAM they persisted in 27.7% of cases. Two patients (3%) interrupted TAM therapy because of dizziness, and 3 patients (4%) interrupted bicalutamide therapy because of painful gynecomastia. In arm B, the prevalence of BEs was 35% after 12 months of therapy. The difference in BEs between the 2 arms was statistically significant (P < .0001). The differences in prevalence of gynecomastia and breast pain between the 2 arms both favored TAM prophylaxis (P < .0001 and P < .001, respectively). Up to 35% of patients had BEs of low intensity, never requiring bicalutamide withdrawal. Two patients (3%) interrupted the treatment because of gastrointestinal intolerance. No difference emerged between the 2 arms in terms of prostate-specific antigen (PSA) response, plasma testosterone levels, and tumor progression. CONCLUSION: Bicalutamide-induced BEs can be prevented to a significant degree by prophylaxis with TAM 10 mg/day or effectively treated with TAM therapy 20 mg/day. Persisting BEs are of higher intensity after therapy than after prophylaxis.

Oral chemotherapy in hormone-refractory prostate carcinoma patients unwilling to be admitted to hospital.

OBJECTIVES: To investigate the safety and efficacy in terms of PSA response of a low-dose oral combination of estramustine phosphate (EMP) and etoposide (VP16) in hormone- refractory prostate cancer (HRPC) patients. Well-tolerated outpatient chemotherapy regimens for patients unfit and/or unwilling to be admitted to hospital are needed. METHODS: Fifty-six HRPC patients with metastatic disease (median age 75 years) were randomized between arm A (daily oral EMP 10 mg/kg, in 3 doses) and arm B (28-day cycle with low-dose EMP 3 mg/kg once daily plus VP16 25 mg/m(2) once daily on days 1 through 14). Baseline characteristics between the two groups were similar. LHRH therapy was maintained. Anti- androgen was stopped 1 month before entry. RESULTS: The low-dose combination was better tolerated, with a significant advantage in terms of time to treatment interruption for any reason (p = 0.01) or toxicity (6 vs. 12 months, p = 0.02). A trend in favour of arm B was evident in terms of PSA reduction (41.4 vs. 15%), performance status and pain improvement. Hospital admission due to toxicity was never required for arm B patients and there were no treatment-related deaths. CONCLUSIONS: Low-dose oral combination of EMP and VP16 might represent a treatment option for patients unfit for i.v. chemotherapy. This regimen requires minimal toxicity monitoring when administered at home for prolonged periods.

Transrectal ultrasonography in infertile patients with persistently elevated bacteriospermia.

AIM: To identify and define prostate and seminal vesicle abnormalities in patients with chronic male accessory gland infection (MAGI) who failed to respond to antibacterial treatment. METHODS: We selected 67 consecutive patients with MAGI and persistently elevated bacteriospermia (=or>10(6) colony forming units [CFU]/mL) after three antibiotic courses. Fourteen infertile patients with initial chronic microbial (=or>10(6) CFU/mL) MAGI who responded to antibacterial treatment (<10(3) CFU/mL) served as a control group. All patients and controls underwent transrectal ultrasonography (TRUS) scans and semen analysis. Patients with low seminal plasma volume (<1.5 mL) underwent both pre-ejaculatory and post-ejaculatory TRUS examination. RESULTS: TRUS revealed multiple abnormalities indicative of: (i) bilaterally extended prostato-vesiculitis (group A: 52 cases, 77.6%) (nine of these patients also had micro-emphysematous prostate abscess); and (ii) prostato-vesiculitis with unilateral or bilateral sub-obstruction of the ejaculatory ducts (group B: 15 cases, 22.4%). Mean sperm concentration, total sperm number, ejaculate volume and pH value were significantly higher in group A than in group B. In addition, sperm forward motility and the percentage of normal forms were significantly worse than in controls, whereas leukocyte concentration was significantly higher in group A. Group B patients had all sperm parameters, but their pH values, significantly different from those of controls. CONCLUSION: Although antibiotic therapy is considered suitable when microbial MAGI is suspected, it is impossible to account for a poor response to antibiotics merely on the basis of conventional criteria (clinical history, physical and ejaculate signs). Thus, TRUS may be helpful in the follow-up of these patients.