BACKGROUND: The aim of this study was to evaluate the safety and effectiveness of sildenafil in male peritoneal dialysis patients with erectile dysfunction. METHODS:Sixteen peritoneal dialysis patients were recruited to this prospective, randomized, double-blind, placebo-controlled, crossover study of sildenafil during a period of 8 weeks. Efficacy was assessed by using the International Index of Erectile Function and a Global Assessment Question. Penile arterial supply was assessed by means of Doppler ultrasound in all patients, and adverse events were recorded. RESULTS: Three patients failed to complete the study (1 patient received a renal transplant, 1 patient died unrelated to the study, and 1 patient withdrew for personal reasons). In the remainder, there was a significant improvement in erectile function with sildenafil compared with placebo (P = 0.01) and the baseline assessment (P = 0.002). There were also significant improvements in intercourse satisfaction (P = 0.002) and overall satisfaction (P = 0.005) compared with baseline. In response to the Global Assessment Question, 75% of patients reported improvement in erections. Only 1 adverse event was reported: a headache, which resolved after the third dose of sildenafil. CONCLUSION:Sildenafil caused a significant improvement in erectile function in peritoneal dialysis patients, with a success rate at least as high as that reported in other patient groups. The drug was well tolerated, with few adverse events.
RCT Entities:
BACKGROUND: The aim of this study was to evaluate the safety and effectiveness of sildenafil in male peritoneal dialysis patients with erectile dysfunction. METHODS: Sixteen peritoneal dialysis patients were recruited to this prospective, randomized, double-blind, placebo-controlled, crossover study of sildenafil during a period of 8 weeks. Efficacy was assessed by using the International Index of Erectile Function and a Global Assessment Question. Penile arterial supply was assessed by means of Doppler ultrasound in all patients, and adverse events were recorded. RESULTS: Three patients failed to complete the study (1 patient received a renal transplant, 1 patient died unrelated to the study, and 1 patient withdrew for personal reasons). In the remainder, there was a significant improvement in erectile function with sildenafil compared with placebo (P = 0.01) and the baseline assessment (P = 0.002). There were also significant improvements in intercourse satisfaction (P = 0.002) and overall satisfaction (P = 0.005) compared with baseline. In response to the Global Assessment Question, 75% of patients reported improvement in erections. Only 1 adverse event was reported: a headache, which resolved after the third dose of sildenafil. CONCLUSION:Sildenafil caused a significant improvement in erectile function in peritoneal dialysis patients, with a success rate at least as high as that reported in other patient groups. The drug was well tolerated, with few adverse events.
Authors: Mariacristina Vecchio; Sankar D Navaneethan; David W Johnson; Giuseppe Lucisano; Giusi Graziano; Marialuisa Querques; Valeria Saglimbene; Marinella Ruospo; Carmen Bonifati; Emmanuele A Jannini; Giovanni F M Strippoli Journal: Clin J Am Soc Nephrol Date: 2010-05-24 Impact factor: 8.237