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Yamaçake KGR et al, 2018: 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.

Yamaçake KGR, Carneiro F, Cury J, Lourenço R, Françolin PC, Piovesan AC, Srougi M, Nahas WC, Antonopoulos IM.
Division of Radiology, Division of Urology, Renal Transplantation Unit, Division of Urology, University of São Paulo Medical School, São Paulo, Brazil.

Abstract

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.

Int J Impot Res. 2018 Aug 14. doi: 10.1038/s41443-018-0062-2. [Epub ahead of print]

 

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Comments 1

Hans-Göran Tiselius on Friday, 23 November 2018 07:25

Treatment of ED is generally difficult and particularly so also in patients with transplanted kidneys. The authors of this report randomized patients to active or sham treatment and according to the methodological description the sham treatment seems apparently realistic.
Like in other studies on ESWT, interpretation of the results is difficult and although the achievements were promising they are not absolutely convincing. The difference in mean EHS after 4 months was statistically significant, but numerically small and in favor of sham treatment. The mean IIEF score after 4 months was 17.2 ± 5.7 in ESWT-treated patients and 16.5 ± 5 in patients subjected to sham therapy. Is this difference clinically relevant?

It is obvious that the treatment result is difficult to predict and according to Figure 3 the IIEF score after treatment differed only slightly between the two groups, but patients in the ESWT group had lower baseline IIEF score.

According to the results in Figure 4 only three of the ESWT-treated patients came up to and IIEF score that was normal or close to normal. One patient had an obvious improvement, but he did not reach a normal level.

My own interpretation is that some improvements can be expected from Li-ESWT in selected patients, but also, according to literature data, that a combination with pharmacological treatment might be better. Unfortunately, this combination was considered undesirable for patients with transplanted kidneys.

Future studies will hopefully disclose how useful ESWT will be for this group of patients.

Treatment of ED is generally difficult and particularly so also in patients with transplanted kidneys. The authors of this report randomized patients to active or sham treatment and according to the methodological description the sham treatment seems apparently realistic. Like in other studies on ESWT, interpretation of the results is difficult and although the achievements were promising they are not absolutely convincing. The difference in mean EHS after 4 months was statistically significant, but numerically small and in favor of sham treatment. The mean IIEF score after 4 months was 17.2 ± 5.7 in ESWT-treated patients and 16.5 ± 5 in patients subjected to sham therapy. Is this difference clinically relevant? It is obvious that the treatment result is difficult to predict and according to Figure 3 the IIEF score after treatment differed only slightly between the two groups, but patients in the ESWT group had lower baseline IIEF score. According to the results in Figure 4 only three of the ESWT-treated patients came up to and IIEF score that was normal or close to normal. One patient had an obvious improvement, but he did not reach a normal level. My own interpretation is that some improvements can be expected from Li-ESWT in selected patients, but also, according to literature data, that a combination with pharmacological treatment might be better. Unfortunately, this combination was considered undesirable for patients with transplanted kidneys. Future studies will hopefully disclose how useful ESWT will be for this group of patients.
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