bigEDfix FAQ

GENERAL

What is the ED1000?

The ED1000 is a paradigm shift in the treatment of vascular origin Erectile Dysfunction utilizing Extracorporeal Shockwaves.

Who can use the ED1000?

The ED1000 should be used by a trained Personal. This could be a Urologist or a nurse with the supervision of a Urologist. All users should undergo training by Medispec or its local authorized representative to operate the ED1000.

What are Shockwaves?

Shockwaves are acoustic waves, similar to ultrasound waves that are generated by an underwater high-voltage spark. Shockwaves are single pulse waves with high-pressure amplitude, small pulse width and short rise time. Shockwaves are delivered noninvasively, focused by a special ellipsoid reflector.

What is the inclusion criteria for treatment?

Patients with documented vascular related ED and no hormonal, neurologic or psychological pathology.

What are the exclusion criteria for treatment?

Patients with the following conditions:

  • Any cause of ED other than vascular etiology
  • Patients with penile tumour
  • Patients with prostatic tumour
  • Patients with testicular tumour
  • Patients with local tumour at the treatment area
  • Patients with skin wound at the treatment area
  • Patients with infection in the treatment area

Is the treatment conducted in a discreet manner?

The Urological clinics are by nature discreet, during the treatment only the treatment administrator is present and the treatment is held in a private room.

Is it necessary to hospitalize the patient?

There is no need to hospitalize the patient before or after the treatment; the treatment is a non-invasive painless and the patient is able to return to his daily routine.

I have heard that the shock wave applicator (lithotripter) in the Urology department is noisy and there is a need to wear ear protection. Is it required during ED treatment?

No. Unlike Urologic applications, ED treatment with shock wave requires less powerful shock waves (1/10th of Lithotripsy). For that reason the ED1000 is fitted with a smaller generator, producing less intense electrical sparks thus generating significantly less noise. There is no need to wear ear protection during treatment.

Is there a significant difference between Erectile Dysfunction Shockwave Therapy and other ED treatment option?

Shockwave Therapy is a non-invasive therapy where we trigger a natural mechanism in the patient body to address vascular problems that cause Erectile Dysfunction and not only treat the symptoms.

In other therapies treatment can involve either pharmaceutical therapy using PDE5-I that have a systematic load on different organs and can be accompanied with different reported side-effect or using Vacuum pumps to induce a mechanical erection.

Other treatments options offer a temporary solution that treats the symptom of ED but not the cause.

Why should I prefer this treatment instead of PDE5-I that I take today?

Although there is no doubt on the impact that PDE-5 inhibition medication has on the field of sexual medicine, there is a growing realization that pharmacotherapy is not sufficient, especially in such delicate and complex matter as the male sexuality. When it comes to the male sexuality, we have to attribute physiological as well as emotional factors that concern the treatments of ED and have not been solved by PDE-5 inhibitors, such as spontaneity in sexual intercourse and mainly the self esteem that is damaged by the dependency on medication in order to be able to have sexual intercourse. The ED1000 is able to address these issues and also treat the cause of the problem not just manage the symptoms and without the systematic load that we have with pharmacotherapy.

PRE-TREATMENT

Is there a need for a special pre-treatment procedure?

There is no need for any special pre-treatment procedure.

What are the reasons for choosing the suggested protocol?

This protocol was chosen based on our extensive clinical proven experience in the treatment of cardiovascular ischemia, in order to maximize the effect of shockwaves on the development of collaterals. Collaterals develop usually within 2-3 weeks, which is the reason for the chosen intervals between treatments. In addition, animal studies found that maximal expression of angiogenic factors occurs after 4 weeks.

DURING TREATMENT

Is the treatment painful?

The treatment is not painful and there is no need to use any kind of sedation during treatment.

What does the patient feel during treatment?

The patient sometimes feels a tickling sensation in the treatment area during treatment. This effect passes immediate or shortly after the treatment is stopped.

POST-TREATMENT

Is there any side effect of the treatment?

No. There were no reports of side effects during, immediately after or post-treatment.

Is it possible to undertake repeated sessions?

Yes. Shockwaves could be delivered as long as there is a clinical need for ED therapy.

Is there a need for special post-treatment procedures?

No, there is no need for any post-treatment procedures.

Can the patient engage in sexual activity after each session?

There is no restriction on sexual activity before or after treatments.

How soon after treatment protocol initiation shall I feel any difference in sexual performance?

Some of the patients have reported an improvement after 6 treatments already (3 weeks from initiation of therapy).

Can PDE5-I be used until I feel clinical improvement with EDSWT treatment?

PDE5-I are permitted to use until reaching satisfying improvement.

How long does the treatment effect last?

There is clinical evidence that the treatment effect is lasting from 6 months and up to 18 months.

Is there a change in the intake of medication after treatment?

Yes. There is a reduction in the consumption of PDE5-I after completion of all treatments sessions.