A phase II, single-blind, randomized, crossover evaluation of the safety and efficacy of avanafil using visual sexual stimulation in patients with mild to moderate erectile dysfunction.

OBJECTIVE: To evaluate the safety, efficacy and time course of three doses of avanafil (50 mg, 100 mg and 200 mg) compared with sildenafil 50 mg or placebo, given in conjunction with visual sexual stimulation (VSS) videos in men with mild to moderate erectile dysfunction (ED). PATIENTS AND METHODS: Male patients, 35-70 years of age, with mild to moderate ED of ≥6 months duration, were included in the study. During the course of the study, each patient received placebo, active control (sildenafil 50 mg), and one dose of avanafil (50 mg, 100 mg or 200 mg), all administered in random order at least 72 h apart. RigiScan® (Dacomed Corp., Minneapolis, MN, USA) monitoring was used in conjunction with 20-min VSS videos (20, 60, and 100 min after dosing) to determine the duration of and time to ≥60% penile rigidity, maximum rigidity, tumescent activity units (TAUs), rigidity activity units (RAUs), and responses to the five-point Erection Assessment Scale. Safety assessments included adverse events (AEs), vital sign changes in response to dosing, laboratory results (complete blood counts, chemistry panel, prostate-specific antigen, serum testosterone, prothrombin time and urine analysis) and physical examination findings. RESULTS: Eighty-three patients were randomized and received at least one dose of study medication; 82 patients completed the study. Peak response to avanafil occurred in the early interval (20-40 min after dosing), while peak response to sildenafil occurred either in the middle (60-80 min) or late (100-120 min) intervals after dosing. Results were qualitatively similar for all other efficacy endpoints. During the 20-40-min interval, the majority of values for TAUs and RAUs with the avanafil 50-mg, 100-mg and 200-mg treatments were significantly superior to placebo (P < 0.05). Avanafil treatment was generally well tolerated; facial flushing (7-15%) was the most commonly observed AE, and no visual disturbances were reported. CONCLUSION: A favourable safety profile and improvement in sexual function, coupled with rapid onset of action and durability of effect, make avanafil an attractive option for males with ED, especially in the setting of on-demand treatment.

Infection retardant coated inflatable penile prostheses decrease the incidence of infection: a systematic review and meta-analysis.

PURPOSE: This systematic review was done to compare the effectiveness of infection retardant coated inflatable penile prostheses vs noncoated devices. MATERIALS AND METHODS: We systematically reviewed PubMed® and Galileo® to identify all relevant case studies. The postoperative infection incidence rate was compared for coated and noncoated inflatable penile prostheses to determine whether coating the implant affects the rate of surgical implant infection. RESULTS: Included in analysis were 14 clinical case studies in a total of 9,910 patients with a first time implant, including 5,214 inflatable penile prostheses without an infection retardant coating and 4,696 coated inflatable penile prostheses impregnated with minocycline/rifampin (3,158), rifampin/gentamycin immersion (181), vancomycin/gentamycin immersion (181) and a hydrophilic coating only (1,176). For noncoated vs coated prostheses the infection rate was 2.32% vs 0.89% (p <0.01), including 0.63%, 0.55%, 4.42% and 1.11% for minocycline/rifampin, rifampin/gentamycin immersion, vancomycin/gentamycin immersion and hydrophilic coatings, respectively. CONCLUSIONS: This analysis documents a significant advantage of using coated compared to noncoated inflatable penile prostheses to prevent postoperative device infection. Infection retardant coatings that allow antibiotics to elute off the device components decrease the incidence of device infection by approximately 50%. Future studies must address novel techniques, such as preventing bacterial adhesion, to further decrease infectious etiologies.