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Low Intensity Shock Wave Therapy (LI-ESWT) for Erectile Dysfunction in Post Radical Prostatectomy Patients Not Responding to PDE5 Inhibitors (LI-ESWT) (LI-ESWT)

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ClinicalTrials.gov Identifier: NCT01317680
Recruitment Status : Unknown
Verified May 2012 by i_gruenwald, Rambam Health Care Campus.
Recruitment status was:  Recruiting
First Posted : March 17, 2011
Last Update Posted : May 24, 2012
Sponsor:
Information provided by (Responsible Party):
i_gruenwald, 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 (damage that can occur after radical prostatectomy in addition to neural damage or solely) that do not respond to oral therapy (PDE-5 inhibitors).

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Device: Omnispec model ED1000 Device: Sham control Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low Intensity Shock Wave Therapy for Erectile Dysfunction in Post Radical Prostatectomy Patients Not Responding to PDE5 Inhibitors- a Double Blind Placebo Controlled Study (LI-ESWT)
Study Start Date : March 2011
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 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: Omnispec model ED1000
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.
Placebo Comparator: Sham control
We use the same probe that induces the same sensation on the penis and the same noise yet no energy.
Device: Sham control
We use the same probe that induces the same sensation on the penis and the same noise yet no energy



Primary Outcome Measures :
  1. Increase in IIEF ED Domain Questionaire of >5 is considered as a treatment success [ Time Frame: 3 months ]

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


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:

  • Prior prostatectomy surgery
  • ED of more than 6 months
  • Rigidity score < 3 during PDE5i therapy
  • Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

  • Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
  • Clinically significant chronic hematological disease
  • Anti-androgens, oral or injectable androgens
  • Radiotherapy in pelvic region

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): NCT01317680


Locations
Israel
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Ilan Gruenwald, MD    00972-4-8542882    i_gruenwald@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

Responsible Party: i_gruenwald, MD, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01317680     History of Changes
Other Study ID Numbers: 0037-11-RMB
First Posted: March 17, 2011    Key Record Dates
Last Update Posted: May 24, 2012
Last Verified: May 2012

Keywords provided by i_gruenwald, Rambam Health Care Campus:
Erectile Dysfunction
ED
PDE5 inhibitors
LI-ESWT

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action