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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
i_gruenwald, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01317693
First received: March 8, 2011
Last updated: December 18, 2012
Last verified: December 2012

March 8, 2011
December 18, 2012
March 2011
June 2012   (final data collection date for primary outcome measure)
Change in IIEF-ED Domain Questionaire Score > 5 points is considered treatment success [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01317693 on ClinicalTrials.gov Archive Site
Rigidity Score Questionaire- an increase by at least 1 point is considered success [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction
Extracorporeal Shock Wave Therapy With a Wide Focus Probe for the Treatment of Erectile Dysfunction

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Erectile Dysfunction
Device: Low intensity shock waves
1500 shocks, Energy Density - 0.09 mJ/mm2
Other Name: Omnispec model ED1000
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.
Intervention: Device: Low intensity shock waves
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
December 2013
June 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 80 Years
No
Contact: Ilan Gruenwald, MD 00972-4-8542882 i_gruenwald@rambam.health.gov.il
Israel
 
NCT01317693
0571-10-RMB
Yes
i_gruenwald, Rambam Health Care Campus
Rambam Health Care Campus
Not Provided
Principal Investigator: Ilan Gruenwald, MD Rambam Health Care Campus
Study Director: Yoram Vardi, Prof. Rambam Health Care Campus
Rambam Health Care Campus
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP