Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction
Vasculogenic Erectile Dysfunction
About this trial
This is an interventional treatment trial for Vasculogenic Erectile Dysfunction
Eligibility Criteria
Inclusion Criteria:
- The patient must be willing and able to provide informed consent.
- The patient is a male between >30 and <80 years of age.
- PDE5i responsive or non-responsive. If on PDE5i patient will discontinue medication for 4 weeks before IIEF.
- Stable sexual relationship for over 3 months prior to enrollment.
- A minimum of 2 sexual attempts per month for at least one month prior to enrollment.
- Erectile dysfunction lasting for over 6 months and not more than 5 years.
- Baseline IIEF-EF score between 11 and 25. If taking PDE5i, stop medication for at least 4 weeks before baseline IIEF-EF.
- Testosterone level 300-1000 ng/dL.
- If diabetic, HgbA1C level ≤ 7.5% within 1 month prior to enrollment.
Exclusion Criteria:
- The patient is currently or has participated in another study within the past three months, that may interfere with the results or conclusions of this study.
- The patient is under judicial protection (prison or custody).
- The patient is an adult under guardianship.
- The patient refuses to sign the consent.
- History of radical prostatectomy or extensive pelvic surgery ever.
- Past radiation therapy of the pelvic region within 12 months prior to enrollment.
- Recovering from any cancer within 12 months prior to enrollment.
- Neurological disease such as Alzheimers or Parkinsons disease which affects erectile function at the discretion of the investigator.
- Psychiatric diagnosis or medications such as antidepressants which affects erectile function or any other medications at the discretion of the investigator.
- Anatomical malformation of the penis, including Peyronie's disease.
- Testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment.
- HgbA1C level > 7.5% within 1 month prior to enrollment.
- Androgen deprivation treatment in the last year.
- History of spinal cord injury.
- The patient is taking blood thinners (eg Coumadin, Plavix)
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
720 shockwave therapy
600 shockwave therapy
5 daily sessions of shockwave therapy within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura).
Three sessions of shockwave therapy per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura) Following the last treatment session, each patient will resume his baseline consumption of phosphodiesterase 5 inhibitor, in terms of type and dose of drug, for the remainder of study duration.