TREATMENT OF ERECTILE DYSFUNCTION WITH SILDENAFIL CITRATE IN RENAL TRANSPLANT RECIPIENT: A CROSS OVER PLACEBO CONTROLLED TRIAL

Abstract

P283 Aims: Sildenafil is an effective modality of treatment of Erectile dysfunction (ED) in normal population. We conducted a study to assess safety and efficacy of sildenafil in renal transplant patients with ED. Methods: Thirty renal allograft recipient with erectile dysfunction were enrolled for the, cross over, placebo controlled study. Sildenafil was given in dose of double blind 50mg 1 hr before anticipated sexual activity and after completing the performa for International index of erectile function (IIEF) score. Placebo and sildenafil were used in blinded manner with washout period. The outcome was analyzed at the end of the two study periods in each patient in terms of improvement in IIEF score and global efficacy question. Results: The mean age of renal transplant recipients, was 40±8.5 years, duration of transplant 4.7±3 years, duration of erectile dysfunction 17.5±22 months. The mean IIEF score at baseline and after treatment with sildenafil were (a) frequency of erection during sexual activity (2.2±0.6 vs 3.7±0.7, P<0.001), (b) frequency of erections hard enough for penetration (1.8±0.7 vs 3.5±0.6, P <0.001), (c) penetration ability (2.2±0.7 vs 3.9±0.6) P<0.001), (d) maintenance frequency (2.1±0.9 vs 3.8±0.6, p<0.006), (e) maintenance ability (1.7±0.84 vs 3.7±0.9, p<0.001), (f) intercourse frequency (1.3±0.6 vs 2.9±1.1, p<0.001), (g).intercourse satisfaction (1.7±0.8 vs 3.6±1.8, p<0.001), (h) intercourse enjoyment 2.1±0.9 vs 3.7±0.7, p<0.001, (i) ejaculation frequency (2.1±1.2 vs 4 ±0.9, P<0.001), (j) Orgasm frequency (2.1±1.1 vs 3.7±0.7, p<0.001), (k) desired frequency (3.2±1.2 vs 3.5±0.6, P<0.32), (l) desire level (2.8±0.8vs 3.1±0.8, P=0.6), (m) Overall satisfaction (2.5±0.7 vs 3.7±0.5, p<0.001), (n) Relationship satisfaction (2.7±0.8 vs 3.5±0.6, p<0.001), (o) erectile confidence (2.6±0.8 vs 3.67± 0.6, p<0.001). After crossed over to placebo, IIEF score was similar pre and post placebo therapy. On global efficacy question analysis, 26 out of 30 patients have shown significant improvement in erectile function after sildenafil therapy. There was no change in graft function (serum Creatinine1.48±0.36 vs 1.4±0.39 mg/dl) and CsA level ((90±9.9 vs 91±10.5 ng/ml) pre and post sildenafil treatment. In selected 4 patients mean AUC of cyclosporine 7454±1483 vs 7460±1480 ng-hour/ml was similar with and without sildenafil. None of the patients discontinued the drug due to side-effects except one who had visual symptoms. Conclusions: Sildenafil can be used safely and is an effective firm of therapy for ED in renal transplant patients and it does not affect the CsA blood levels.