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Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT01317693
Recruitment Status : Unknown
Verified December 2012 by i_gruenwald, Rambam Health Care Campus.
Recruitment status was:  Recruiting
First Posted : March 17, 2011
Last Update Posted : December 19, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered to the penile tissue. Shockwaves are created by a special generator and are focused using a specially designed shockwave applicator apparatus. The shockwaves are delivered through the applicator covering the corpora cavernosa of the penis. In previous studies the investigators used a medium focused probe and in this study the investigators are evaluating results of this therapy using a wider focus probe in the aim of improving results of treatment.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Device: Low intensity shock waves Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction
Study Start Date : March 2011
Primary Completion Date : June 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Treatment LI-ESWT
Device: Extracorporeal Shockwave Therapy Generator (Omnispec model ED1000) Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.
Device: Low intensity shock waves
1500 shocks, Energy Density - 0.09 mJ/mm2
Other Name: Omnispec model ED1000


Outcome Measures

Primary Outcome Measures :
  1. Change in IIEF-ED Domain Questionaire Score > 5 points is considered treatment success [ Time Frame: 13 weeks ]

Secondary Outcome Measures :
  1. Rigidity Score Questionaire- an increase by at least 1 point is considered success [ Time Frame: 13 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • ED of more than 6 months
  • At least 50% unsuccessful to attempt sexual intercourse for 4 times at 4 different days
  • Positive response to PDE-5 inhibitors
  • IIEF-5 domain score of 12-20 denoting mild to severe ED
  • Non-Neurological pathology
  • Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

  • NPT - normal/flat
  • Prior prostatectomy surgery
  • Any cause of ED other than vascular related
  • Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities
  • Clinically significant chronic hematological disease
  • Cardiovascular conditions that prevent sexual activity
  • History of heart attack, stroke or life-threatening arrhythmia within the prior 6 months.
  • Cancer within the past 5 years.
  • Anti-androgens, oral or injectable androgens
  • Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01317693


Contacts
Contact: Ilan Gruenwald, MD 00972-4-8542882 i_gruenwald@rambam.health.gov.il

Locations
Israel
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Ilan Gruenwald, MD    00972-4-8542882    i_gruewald@rambam.health.gov.il   
Principal Investigator: Yoram Vardi, Prof.         
Principal Investigator: Ilan Gruenwald, MD         
Sub-Investigator: Boaz Appel, MD         
Sub-Investigator: Yaron Ofer, MD         
Sub-Investigator: Suliman Nassar, MD         
Sub-Investigator: Omar Massarwa, RN BA         
Sub-Investigator: Ezra Gerber, RN BA         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Ilan Gruenwald, MD Rambam Health Care Campus
Study Director: Yoram Vardi, Prof. Rambam Health Care Campus
More Information

Responsible Party: i_gruenwald, MD, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01317693     History of Changes
Other Study ID Numbers: 0571-10-RMB
First Posted: March 17, 2011    Key Record Dates
Last Update Posted: December 19, 2012
Last Verified: December 2012

Keywords provided by i_gruenwald, Rambam Health Care Campus:
LI-ESWT
Erectile Dysfunction
ED
Shock waves
Therapy

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