Extracorporeal Shockwave Therapy in the Treatment for Erectile Dysfunction in Male Renal Transplant Recipients
Condition: Erectile Dysfunction; Renal Transplant
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      The primary objective of this study is to determine the impact of the shock wave application
      in renal transplant patients with diagnosis of erectile dysfunction. Secondary objectives are
      to assess the effects of therapy on quality of life and depression.

      It is expected that with the study is defined the usefulness of the therapy and the
      dissemination of knowledge generated for change in clinical management in renal transplant
      patients with erectile dysfunction.
    

Detailed description: 
      The Renal Transplant Unit, performs about 230 kidney transplants per year and has a screening
      service for registration of candidates for renal transplantation, interviewing about 70
      patients a month. Since the potential and likely benefits of extracorporeal shock wave
      therapy in these patients as well as the anticipation of mild side effects, there is no
      reason for refusal to participate in the study.

      Patients who meet the inclusion criteria will be divided into 2 groups using a randomization
      table created by computer. Patients will be followed for 2 years.

      The study procedure and monitoring will be performed on an outpatient basis.

      Patients are divided into a group of extracorporeal shockwave (ESWT) treatment and placebo in
      a ratio of 1: 1 using a table of random numbers generated by computer.

      The 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) and the crura bilaterally. The duration of each ESWT session will be approximately
      10 minutes and 2000 shocks will be applied 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 cilyndric
      (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. The effective probe will be replaced by a
      similar one 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.

      The diameter of the cavernous arteries is measured before and after intracavernosal injection
      application 20 mcg alprostadil (Caverject ®). In addition, vascular disorders, or stenotic
      atheromatous lesions will be investigated. The systolic and diastolic velocities of the
      cavernous arteries are evaluated 5,10 and 15 minutes after drug injection.

      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 and cardiovascular disease 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.

      - Calculation sample

      To define the sample size, the investigators must take into account: data variability (within
      each group) and the difference the investigators want to observe the parameters to be studied
      before and after treatment, beyond the level of significance and power of the test.

      The investigators will assume that the data follow a normal distribution and will use the
      paired t-test methodology, considering that the same patients will be evaluated in both
      conditions.

      The level of significance that work is 5%. Suitable power will be considered to be greater
      than 80%.

      The investigators observe a difference to 5 points required amount of samples is very small,
      whereas only 3 patients t-test. for the non-parametric test we consider a sample of 4
      patients.
    

Intervention name(s): Extracorporeal shockwave therapy; Extracorporeal shockwave therapy - sham treatment; Penile ultrasound Doppler with intracavernosal injection application 20 mcg alprostadil
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): A probe similar to the treatment group will be used. The noise and appearance is similar. The probe 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.; Diagnostic test will be performed before treatment and after 3 to 4 months after therapy.
Intervention MeSH terms: Alprostadil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Erectile Dysfunction; Shockwave therapy; Renal Transplant; Male; Renal Transplant Recipients