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Extracorporeal shockwave therapy in the treatment for erectile dysfunction in male renal transplant recipients

Grant number: 15/17629-4
Support type:Scholarships in Brazil - Doctorate (Direct)
Effective date (Start): December 01, 2015
Effective date (End): November 30, 2018
Field of knowledge:Health Sciences - Medicine - Surgery
Principal researcher:Ioannis Michel Antonopoulos
Grantee:Kleiton Gabriel Ribeiro Yamaçake
Home Institution: Hospital das Clínicas da Faculdade de Medicina da USP (HCFMUSP). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil

Abstract

Introduction: The treatment of Erectile Dysfunction (ED) in renal transplant recipients is intended to improve the sexual performance of patients without interfering with the current or future role of the transplant. In addition, there is concern that IPDE-5 can affect the levels of immunosuppressive drugs and graft function after kidney transplantation. In this context, alternative treatments have been proposed to deal with these issues. To date, no studies have evaluated these alternatives in renal transplant patients with ED.The Shock Wave Therapy Extracorporeal (ESWT) has been applied and studied in cardiovascular disease and erectile dysfunction. Shock waves can induce angiogenesis have been used in the treatment of chronic wounds, ischemic peripheral neuropathy and cardiac tissue successfully. ESWT may be considered a potential treatment option for men with severe erectile dysfunction due to mainly vascular causes in order to make them independent or less dependent on IPDE-5. So it makes mister standardize ESWT therapy. Objectives: The primary objective of this study is to determine the impact of the shock wave application in renal transplant patients with vascular cause of ED diagnosis. Secondary objectives are to evaluate the effects of therapy on quality of life and depression. Methods: Will be selected male patients aged between 40 and 70 years undergoing kidney transplant for at least 6 months and diagnosed with erectile dysfunction for at least 6 months. Patients will be recruited on the IIEF score <21 and with a functioning kidney graft. Patients will be divided into 2 groups using a randomization tableThe ESWT protocol is protocol-based suggested by Vardi et al. 6. Patients will undergo a 2 treatment sessions per week for 3 weeks. The penis is pulled manually, and shock waves are applied throughout the penile shaft (except the glans) andthe crus bilaterally. The duration of each ESWT session will be approximately 10 minutes being applied in 2000 shocks per session) with an intensity of energy of 1 mJ/mm 2. The volume of penile tissue exposed to shock waves at each site will be cilíndric (diameter: 18 mm, height 100 mm). No local or systemic analgesia is required during the procedure. To placebo therapy will be used the same device being replaced effective probe for the same but that emits zero energy during each treatment. Local application generates noise and a feeling of popping at the application site which will also be experienced by patients in the placebo group being impossible for the patient to discern which treatment group belongs. Penile ultrasound doppler and drug erection will be performed before therapy and after treatment to evaluate the results. After obtaining the patient signed informed consent, will be included in the study. Laboratory tests will be held at the hospital laboratory studied variables. The following parameters will be studied during the initial evaluation and follow-up: 1. Clinical: quality of life questionnaire - WHO QOL (World Health Organization - Quality of Life); sexual questionnaire IIEF (International Index of Erectile Function); comorbidities such as hypertension, diabetes, cardiovascular disease and smoking; 2. Laboratory: total testosterone, free testosterone, progesterone, albumin, SHBG, FSH, LH, prolactin, complete blood count, urea, creatinine, total cholesterol and fractions, triglycerides, T3, T4F and TSH; 3. Imaging tests: ultrasound doppler penile before and 3 months after treatment. (AU)

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Academic Publications
(References retrieved automatically from State of São Paulo Research Institutions)
YAMAÇAKE, Kleiton Gabriel Ribeiro. Low-intensity extracorporeal shockwave therapy for the treatment of erectile dysfunction in kidney transplant recipients. 2019. Doctoral Thesis - Universidade de São Paulo (USP). Faculdade de Medicina (FM/SBD) São Paulo.

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