Efficacy & Safety of a 2nd Series of Low Intensity Shock Waves for ED on Partial Responders to First Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01601262
Recruitment Status : Unknown
Verified July 2012 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : May 17, 2012
Last Update Posted : July 26, 2012
Information provided by (Responsible Party):
Rambam Health Care Campus

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Device: Low Intensity Extracorporeal Shock waves (Cardiospec 1000) Phase 3

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of a Second Series of Low Intensity Extracorporeal Shock Wave Therapy (LI-ESWT) Treatment for Erectile Dysfunction Patients Who Were Partial Responders to the Initial Treatment.
Study Start Date : July 2012
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Open label Device: Low Intensity Extracorporeal Shock waves (Cardiospec 1000)
We will apply the cardiospec 1000 unit for LI-ESWL in the penile and inguinal areas, 300 shocks per area, total of 1500 shocks. Full description of treatment series can be seen in the detailed protocol.
Other Name: Cardiospec 1000

Primary Outcome Measures :
  1. IIEF-ED Domain score [ Time Frame: 3 months ]
    Severe ED (6≤IIEF-ED Domain score≤10): an increase of 7 points and above; Moderate ED (11≤IIEF-ED Domain score≤16): an increase of 5 points and above; Mild ED (17≤IIEF-ED Domain score≤25): an increase of 2 points and above.

Secondary Outcome Measures :
  1. Rigidity Score Questionaire [ Time Frame: 3 months ]
    An increase of at least 1 point is considered as a treatment success.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01601262

Contact: Yoram Vardi Vardi, Prof. MD 00972-4-8542819
Contact: Ilan Gruenwald, MD 00972-4-8542882

Rambam Health Care Campus Not yet recruiting
Haifa, Israel
Contact: Ilan Gruenwald, MD    00972-4-8542882   
Contact: Yoram Vardi, Prof. MD    00972-4-8542819   
Principal Investigator: Ilan Gruenwald, MD         
Sub-Investigator: Yoram Vardi, Prof.MD         
Sub-Investigator: Boaz Appel, MD         
Sub-Investigator: Suliman Nassar, MD         
Sub-Investigator: Yaron Ofer, MD         
Sub-Investigator: Omar Massarwa, RN BA         
Sub-Investigator: Ezra Gerber, RN BA         
Sub-Investigator: Arik Shechter, MD         
Sponsors and Collaborators
Rambam Health Care Campus
Principal Investigator: Ilan Gruenwald, MD Rambam Health Care Campus
Study Director: Yoram Vardi, Prof. MD Rambam Health Care Campus

Responsible Party: Rambam Health Care Campus Identifier: NCT01601262     History of Changes
Other Study ID Numbers: 0179-12-RMB
First Posted: May 17, 2012    Key Record Dates
Last Update Posted: July 26, 2012
Last Verified: July 2012

Keywords provided by Rambam Health Care Campus:

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders