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

This study is not yet open for participant recruitment.
Verified July 2012 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01601262
First received: May 15, 2012
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Erectile Dysfunction
 Device: Low Intensity Extracorporeal Shock waves (Cardiospec 1000)
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • IIEF-ED Domain score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • Rigidity Score Questionaire [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    An increase of at least 1 point is considered as a treatment success.


Estimated Enrollment: 300
Study Start Date: July 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01601262

Contacts
Contact: Yoram Vardi Vardi, Prof. MD 00972-4-8542819 yvardi@rambam.health.gov.il
Contact: Ilan Gruenwald, MD 00972-4-8542882 i_gruenwald@rambam.health.gov.il

Locations
Israel
Rambam Health Care Campus Not yet recruiting
Haifa, Israel
Contact: Ilan Gruenwald, MD     00972-4-8542882     i_gruenwald@rambam.health.gov.il    
Contact: Yoram Vardi, Prof. MD     00972-4-8542819     yvardi@rambam.health.gov.il    
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
Investigators
Principal Investigator: Ilan Gruenwald, MD Rambam Health Care Campus
Study Director: Yoram Vardi, Prof. MD Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01601262     History of Changes
Other Study ID Numbers: 0179-12-RMB
Study First Received: May 15, 2012
Last Updated: July 25, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Rambam Health Care Campus:
ED
LI-ESWT

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

ClinicalTrials.gov processed this record on May 19, 2013