Low Intensity Linear Shockwave Therapy for Erectile Dysfunction
Vasculogenic Erectile Dysfunction
About this trial
This is an interventional treatment trial for Vasculogenic Erectile Dysfunction
Eligibility Criteria
Inclusion Criteria:
- The patient has been correctly informed about the study
- The patient must have given his informed and signed consent
- The patient is a man between 40 and 80 years of age
- The patient has ED of Vasculogenic origin
- The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
- The patient has been in a stable heterosexual relationship for over 3 months prior to enrollment
- A minimum of 2 sexual attempts per month for at least one month prior to enrollment
- The patient is suffering from erectile dysfunction lasting for over 6 months and not more than 5 years
- IIEF-EF score between 17 and 25
- Testosterone level 300-1000 ng/dL within 1 month prior to enrollment
- A1C level ≤ 7% within 1 month prior to enrollment
- Patients have at least a natural tumescence during sexual stimulation (EHS score ≥ 1).
Exclusion Criteria:
- The patient is participating in another study that may interfere with the results or conclusions of this study
- Within the past three months, the patient has participated in another study that may interfere with the results or conclusions of this study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection
- The patient is an adult under guardianship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- History of radical prostatectomy or extensive pelvic surgery
- Venous leak
- Past radiation therapy of the pelvic region within 12 months prior to enrollment
- Recovering from cancer within 12 months prior to enrollment
- Neurological disease which effects erectile function
- Psychiatric disease which effects erectile function
- Anatomical malformation of the penis, including Peyronie's disease
- Testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment
- A1C level > 7% within 1 month prior to enrollment
- The patient is taking blood thinners and has an international normalized ratio >3.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
720 Low Intensity shockwave therapy
600 Low Intensity shockwaves therapy
Five daily sessions within a week, Monday thru Friday, in which 720 shocks of treatment energy applied every session to each treated region (left and right corpora cavernosa and crura)
Three weekly sessions for 2 consecutive weeks, Monday-Wednesday-Friday, in which 600 shocks of treatment energy applied 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.