The Effect of Low Intensity Shockwave Therapy for ED in Post Radical Prostatectomy Patients Who Didn't Respond to PDE5i (LI-ESWT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01274949
Recruitment Status : Completed
First Posted : January 12, 2011
Last Update Posted : September 14, 2011
Information provided by (Responsible Party):
Rambam Health Care Campus

Brief Summary:
Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED patients responding to PDE5i's. This study aimed to determine the capability of LI-ESWT to affect patients who underwent radical prostatectomy who did not respond to PDE5 inhibitor therapy.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Device: LI-ESWT Phase 3

Detailed Description:
We included severe ED patients that underwent radical prostatectomy at least one year previously and failed to respond to PDE5i therapy, who scored 0-2 on the rigidity scale (RS) during PDE5i therapy. Treatment included 2 sessions/week for 3 weeks, repeated after a 3-week no-treatment interval. At each session LI-ESWT was applied on the penile shaft and crus for 3 minutes in 5 different penile anatomical sites (intensity of 0.09 mj/mm2, 300 shocks/site). One-month after end of treatment the same baseline assessment was repeated. An active PDE5i medication regime was then provided and final erectile function was reassessed. Main endpoints for success were changes in RS and in the International Index of Erectile Function (IIEF-ED) Domain score. This study further emphasises the need to study specific populations with unique etiologies causing ED.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Low Intensity Shock Wave Therapy in Post Radical Prostatectomy Severe ED Patients Not Responding to Oral Medication
Study Start Date : February 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: LI-ESWT
Low intensity shock wave treatment- 12 sessions
Device: LI-ESWT
Low intensity shock wave treatment - 12 sessions
Other Name: Omnispec model ED1000

Primary Outcome Measures :
  1. IIEF-ED Domain score [ Time Frame: 17 weeks after first visit ]
    Change of 5 points and above in IIEF-ED Domain score

Secondary Outcome Measures :
  1. Rigidity scale [ Time Frame: 17 weeks after first visit ]
    a change to 3 or 4 points in the rigidty scale

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Post Radical prostatectomy
  • ED of more than 6 months
  • Rigidity score ≤ 2 during PDE5i therapy
  • Stable heterosexual relationship for more than 3 months
  • Patients need to know and to agree that the study protocol does not allow any PDE5I therapy till week 13 .

Exclusion Criteria:

  • Prior surgery or radiotherapy in pelvic region
  • Any unstable, psychiatric, spinal cord injury and penile anatomical abnormalities
  • Clinically significant chronic hematological disease
  • Anti-androgens, oral or injectable androgens
  • Cardiovascular conditions that prevent sexual activity

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 identifier (NCT number): NCT01274949

neuro-urology unit, Rambam Medical Center
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Study Director: Ilan Gruenwald, MD Rambam Medical Investigator

Responsible Party: Rambam Health Care Campus Identifier: NCT01274949     History of Changes
Other Study ID Numbers: 3060 radical
First Posted: January 12, 2011    Key Record Dates
Last Update Posted: September 14, 2011
Last Verified: September 2011

Keywords provided by Rambam Health Care Campus:
Erectile Dysfunction
Radical Prostatectomy
Non PDE5 inhibitor responders
Shock wave

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