Low-intensity shockwave therapy for erectile dysfunction in kidney transplant recipients. A prospective, randomized, double blinded, sham-controlled study with evaluation by penile Doppler ultrasonography

Objectives: To study the efficacy of Low intensity Extracorporeal Shockwave Therapy (Li- ESWT) for the treatment of erectile dysfunction (ED) in kidney transplanted men. Methods: Twenty men (mean age = 53.7 years) were selected. This was a double-blinded, prospective, randomized, sham-controlled trial. The ESWT protocol was based in a 2 treatment sessions per week for 3 weeks. The sham treatment was performed using the same device replacing the effective probe for one that emits zero energy. Baseline and follow-up assessment was performed with International Index of Erectile Function Questionnaire (IIEF) score and Erection Hardness Score (EHS) after 1, 4 and 12 months. Penile Doppler was performed before and after treatment. Results: A total of 20 patients were recruited, 10 patients in each group. Baseline scores were similar. The mean EHS in after 1 month were 2.5 +/- 0.85 (Li-EWST) and 2.4 +/- 0.7 (Sham therapy), p = 0.724 . After 4 months it was 2.4 +/- 0.7 and 2.6 +/- 0.84, p = 0,0004 (between the moments) . The baseline IIEF score was 14.9 +/- 3(Sham Theraphy) and 10.9 +/- 5.1 (Li-EWST). The mean IIEF score after 1 month was 15.6 +/- 6.1 (Li-EWST) and 16.6 +/- 5.4 (Sham therapy). The mean IIEF score after 4 months was 17.2 +/- 5.7 (Li-EWST) and 16.5 +/- 5 (Sham therapy), p < 0.0001 (between the moments). IIEF score improvement was higher than 5 in 70% (ranged from 0-10) and in 10% (ranged from 1-14) in Li-ESWT and Sham groups, respectively. The mean change in IIEF score after 12 months was 4.8 in Li-ESWT group .Penile Doppler parameters were similar between groups and did not present improvements. Conclusions: Li-ESWT is a treatment with clinical efficacy. Despite evidences suggesting neoagiogenesis, our short protocol had no impact in penile Doppler parameters.