This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on men undergoing penile implant surgery for the first time. The patients are randomized in a 2:1 ratio of active to sham treatment groups.
Who can participate
Age range30 Years – 70 Years
SexMALE
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Inclusion Criteria:
* The patient must be willing and able to provide informed consent
* The patient is a male between \>/= 30 and =/\< 70 years of age
* The patient has ED based of International Index of Erectile Dysfunction (IIEF) scores
* The patient has been in a stable relationship for over 3 months prior to enrollment
* A minimum of 2 sexual attempts per month for at least one month prior to enrollment - as documented by IIEF
* The patient is suffering from erectile dysfunction and undergoing penile implant surgery for the first time
* IIEF-EF score between 16 and 25
* Testosterone level 300-1000 ng/dL within 1 month prior to enrollment
* A1C level \</= 7% 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
* Evidence of venous leak
* 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 Alzheimer's or Parkinson's disease which affects erectile function at the discretion of the investigator
* Psychiatric diagnosis or medications such as antidepressants, anxiolytic, antipsychotic…