Nephrol Dial Transplant (2003) 18: 411-417
© 2003 European Renal Association-European Dialysis and Transplant Association
Early experience with sildenafil for the treatment of erectile dysfunction in renal transplant recipients
On behalf of the Transplantation Committee of the French Urological Association, 1 Department of Urology, La Pitié-Salpêtrière University Hospital, Paris, 2 Department of Urology, Edouard Herriot University Hospital, Lyon, 3 Department of Urology, Purpan University Hospital, Toulouse, 4 Department of Urology, University Hospital, Amiens, 5 Department of Urology, University Hospital, Bordeaux, 6 Department of Nephrology, Bretonneau University Hospital, Tours, 7 Department of Urology, University Hospital, Nancy, 8 Department of Urology, Bicêtre University Hospital, Le Kremlin Bicêtre and 9 Department of Urology, University Hospital, Nîmes, France
Background. Erectile dysfunction (ED) is common in men with renal failure, but is not always alleviated following kidney transplant. The objective of the present study was to assess the feasibility in renal transplant patients of sildenafil citrate treatment, an agent with proven efficacy in the management of ED.
Methods. This was a phase IV, open, multicentre, 3 month, dose-escalation study. All patients meeting the inclusion criteria were prescribed a dose of 50 mg sildenafil at the first visit. Thereafter the dose could be increased to 100 mg or reduced to 25 mg based on efficacy or tolerability. The primary efficacy parameter assessed the ability of patients to achieve erections sufficient for intercourse and to maintain erections after penetration. Secondary endpoints assessed patient satisfaction with sildenafil and the effect of sildenafil on their quality of life. Patients were carefully monitored throughout the study for adverse events, interactions with immunosuppressive therapy and effect on graft function.
Results. The study included 50 patients in the intent-to-treat population. Sildenafil significantly improved patient's erection ability and the frequency of their erection maintenance. Analysis of the secondary efficacy parameters revealed that 66% of patients believed treatment had improved their erections. Patients reported improvements in their sexual life and partner relationships and a high level of satisfaction with treatment. There were no interactions between sildenafil and the immunosuppressive drugs and there was no significant adverse effect of sildenafil on graft function.
Conclusions. Sildenafil is an effective and well-tolerated agent for the treatment of ED in renal transplant recipients.
Keywords: erectile dysfunction; quality of life; renal transplant; sildenafil
Correspondence and offprint requests to: B. Barrou MD, Service d'urologie, GH Pitié Salpêtrière, 83, bd de l'hôpital, F-75013 Paris, France. Email: benoit.barrou{at}psl.ap-hop-paris.fr