Efficacy & Safety of a 2nd Series of Low Intensity Shock Waves for ED on Partial Responders to First Treatment
Efficacy & Safety of a 2nd Series of Low Intensity Shock Waves for ED on Partial Responders to First Treatment
Low intensity shock waves (LISW) have been proven in animal studies to induce local growth of
 new blood vessels. The investigators hypothesized that LISW therapy could improve the
 symptoms of patients with erectile dysfunction resulting from a problem of blood supply who
 respond to oral therapy (PDE-5 inhibitors). The current study will check the Efficacy and
 Safety of a Second Series of LISW Treatment for Erectile Dysfunction Patients Who Were
 Partial Responders to the Initial Treatment.
The patients will be selected out of the patients with Erectile Dysfunction who received Low
 intensity shock waves and Were Partial Responders to the treatment.

 At the first meeting the patient will receive a full explanation of the study, the potential
 efficacy and risks. After that the patient will be asked to sign an informed consent form.
 The patient's general medical condition and any problems related to sexual dysfunction are
 already known from the previous study he was participating. Also the patient's sexual
 function is already known by sexual function questionnaires that were filled out in previous
 study. The criteria for inclusion and exclusion will be reviewed, as well as physical
 examination. Then shall the patient obtain reporting sexual encounter diaries (SEP) and will
 be asked to avoid using PDE5i's for a month (washout), if he did not do so of some reason
 after ending the previous study, then it would be the first visit (Visit 1). At visit 1 The
 patient will be questioning the sexual function questionnaires without PDE5i's and will pass
 examination performance Endothelial - FMD, the test takes about 10 minutes, it is not an
 invasive test (not involved in inserting an instrument or any medication) and is painless.
 The patient may be asked to also undergo Doppler ultrasound. At the end of visit 1 the
 patient will begin Series of 12 treatments, in which the subject will be treated twice a week
 for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at
 the end of this period will be treated twice a week for 3 weeks (6 treatments). Four weeks
 after the treatment series ends the patient will come for another visit and will be asked to
 fill in questionnaires and perform the FMD and/or Doppler ultrasound test again. The
 patient's ED condition will be followed up for a long term after the end of his participation
 in the study.
Inclusion Criteria:

 1. Incomplete response to active treatment (not placebo) on first round but patient is
 still unsatisfied.

 2. Recurring ED (had improved on first round of shock wave therapy but after a certain
 period of time became clinically worse again) after shock wave therapy.

 3. A minimum of two sexual attempts per month.

 4. An IIEF-ED domain score ≤ 25 post screening, with or without PDE5i intake according to
 assessment on final visit of Shockwave previous treatment.

 5. A stable heterosexual relationship with the same partner for more than three months

 Exclusion Criteria:

 1. Subjects that did not respond at all to the first round as well as those that did not
 respond sufficiently.

 2. Any pelvic surgery during the period after the first round.

 3. Any unstable medical or psychiatric condition, spinal cord injury, or penile
 anatomical abnormalities arising during this period .

 4. cardiovascular conditions that prevent sexual activity.

 5. Recent Use of anti-androgens, or oral or injectable androgens

 6. Recent hormonal, neurologic, or psychological pathology