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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

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.

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Author's contribution

KGRY: manuscript writing and data collection; FC: data management; JC: project management and data analysis; RL: data collection and treatment application; PCF: data collection; ACP: manuscript revision; MS: project management and data analysis; WCN: project management; and IMA: manuscript editing and project design.

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Correspondence to Kleiton G. R. Yamaçake.

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The authors declare that they have no conflict of interest.

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Informed consent was obtained from all individual participants included in the study.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee, and the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Yamaçake, K.G.R., Carneiro, F., Cury, J. et al. 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. Int J Impot Res 31, 195–203 (2019). https://doi.org/10.1038/s41443-018-0062-2

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