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Low Intensity ShockWave Therapy for ED in Non Responders to PDE5i - a Double Blind Placebo Controlled Study (LI-ESWT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Rambam Health Care Campus.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01262157
First received: July 11, 2010
Last updated: May 18, 2011
Last verified: May 2010
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 that do not respond to oral therapy (PDE-5 inhibitors).


Condition Intervention Phase
Erectile Dysfunction
 Device: Extracorporeal Shockwave Therapy Generator (Vascuspec)
Device: Low intensity shock wave therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Randomized Double Blind Placebo Controlled Study on the Effect of Low Intensity Shock Wave Therapy for Erectile Dysfunction in a Group of Patients Not Responding to Oral Therapy

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 [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
    A change of 5 points or more will indicate success


Secondary Outcome Measures:
  • rigidity score [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
    a scale of 3 and above indicates success


Estimated Enrollment: 60
Study Start Date: April 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: placebo
We use the same probe that induces the same sensation on the penis and the same noise yet no energy
 Device: Extracorporeal Shockwave Therapy Generator (Vascuspec)
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.
Other Names:
  • Low intensity shock wave Therapy
  • Extracorporeal Shockwave Therapy
Active Comparator: Shock wave therapy
12 treatment sessions twice a week during 9 weeks with an interim of 3 weeks no treatment
 Device: Low intensity shock wave therapy
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.
Other Name: Low Intensity Extra Corporal Shock Wave Therapy

Detailed Description:

In this study Low intensity shockwaves (1/10 the ones used in Lithotripsy) are delivered directly to the penile tissue using a specially designed shockwave device and probe. Shock wave therapy is applied twice a week for three weeks , then a 3- week interval with no therapy followed by another 3 week period of twice a week shock wave therapy. Before and after sexual function questionnaires and objective measures of erectile function will be performed.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ED of more than 6 months
  • Rigidity score < 3 during PDE5i therapy
  • SHIM <21 during PDE5i therapy
  • Non- hormonal, neurological or psychological pathology Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

  • Prior prostatectomy surgery
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262157

Contacts
Contact: Yoram Vardi, Prof ++97248542819 yvardi@rambam.health.gov.il
Contact: Ilan Gruenwald, MD ++97248542819 i_gruenwald@rambam.health.gov.il

Locations
Israel
Rambam Medical Center Recruiting
Haifa, Israel, 31096
Contact: Yoram Vardi, Prof     ++97248542819     yvardi@rambam.health.gov.il    
Sub-Investigator: Ilan Gruenwald, MD            
Sub-Investigator: Boaz Appel, MD            
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Yoram Vardi, prof Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Prof. Yoram Vardi, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01262157     History of Changes
Other Study ID Numbers: 507-10 RMB
Study First Received: July 11, 2010
Last Updated: May 18, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Rambam Health Care Campus:
Erectile dysfunction
PDE5 Inhibitor
Low intensity shock wave therapy.

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 June 17, 2013