Low Energy Shockwave Therapy for Improving Erectile Dysfunction

"(Month -2)~During this visit, the investigator will:~* Validate the patient's inclusion and exclusion criteria;~* Obtain informed consent from the patient;~* Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope in order to respect patient confidentiality.~* Prescribe 1 month of PDE5i treatment.~* The next visit will be scheduled"

5 mg Tadalafil per day for 1 month

"(Month -1)~During this visit the investigator will:~* Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope in order to respect patient confidentiality.~* Perform a clinical exam; particular attention is given to the recording of complications / adverse events.~* Remind the patient that over the next 4 weeks he is not to take any treatments for his condition (wash-out period).~* The next visit will be scheduled"

"(Day 0)~During this visit the investigator will:~* Verify inclusion and exclusion criteria, and proceed with final inclusion~* Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope in order to respect patient confidentiality.~* Perform a clinical exam; particular attention is given to the recording of complications / adverse events.~* Randomize the patient at the end of the visit~* The patient will go home with a calendar specifying the time and place of the various visits. The patient should have four weekly LIESWT or sham sessions within the next month. The first session may take place the same day and immediately after the present visit."

Following final inclusion, patients will have weekly LIESWT sessions (one session per week for four weeks). Particular attention is given to the recording of complications/adverse events. At the end of each session, the patient is asked to evaluate the level of pain that occurred during the session using a visual analog scale.

Following final inclusion, patients will have weekly sham LIESWT sessions (one session per week for four weeks). Particular attention is given to the recording of complications/adverse events. At the end of each session, the patient is asked to evaluate the level of pain that occurred during the session using a visual analog scale.

"(Month 2)~During this visit the investigator will:~* Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope.~* Perform a clinical exam; particular attention is given to the recording of complications / adverse events."

"(Month 4)~During this visit the investigator will:~* Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope.~* Perform a clinical exam; particular attention is given to the recording of complications / adverse events.~* The patient should have four weekly LIESWT sessions within the next month. The first session may take place the same day and immediately after the present visit."

During the 5th month following final inclusion, all patients will have bi-weekly LIESWT sessions. These will occur twice per week for four consecutive weeks. Particular attention is given to the recording of complications/adverse events. At the end of each session, the patient is asked to evaluate the level of pain that occurred during the session using a visual analog scale.

"(Month 6)~During this visit the investigator will:~* Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope.~* Perform a clinical exam; particular attention is given to the recording of complications / adverse events."

Eight, 11, and 14 months after final inclusion, corresponding to 3, 6 and 9 months following Wave 2, the IIEF, SEP2, SEP3, GAQ and EHS questionnaires will be sent to patients via postal mail.

"(Month 17)~During this visit the investigator will:~* Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope.~* Perform a clinical exam; particular attention is given to the recording of complications / adverse events."