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Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' for Patients With Erectile Dysfunction

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.
 
ClinicalTrials.gov Identifier: NCT01814852
Recruitment Status : Completed
First Posted : March 20, 2013
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Initia

Study Description
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Brief Summary:
This is a prospective, randomized, double-blind clinical study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.

Condition or disease Intervention/treatment Phase
Vasculogenic Erectile Dysfunction Device: Shockwave system Device: Sham treatment Not Applicable

Detailed Description:
This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients to the safety and efficacy of the control sham patients. Patients are randomized in a 1:1 ratio of Renova to the sham control group.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double Blind With Sham Control, Clinical Study to Assess the Safety and Efficacy of Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' in Patients With Erectile Dysfunction
Study Start Date : December 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Shockwaves
4 weekly sessions of low-intensity shockwave therapy
 Device: Shockwave system
Other Name: Renova
Sham Comparator: Control Group Device: Sham treatment
Sham treatment that looks, sounds and feels like real LI-ESWT treatment by Renova.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 1, 3 and 6 months post treatment [ Time Frame: 1, 3 and 6 months post treatment ]

Secondary Outcome Measures :
  1. Change from baseline in the OSS (Overall Sexual Satisfaction) Questions 13 and 14 at 1, 3 and 6 months post treatment [ Time Frame: 1, 3 and 6 months post treatment ]
  2. Change from baseline in the HES (Erection Hardness Score) at 1, 3 and 6 months post treatment [ Time Frame: 1, 3 and 6 months post treatment ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Good general health
  • Vasculogenic ED for at least 6 months
  • International Index of Erectile Function 6 (IIEF-EF) between 11 to 25
  • Positive response to PDE5-I (able to penetrate on demand, Responders)
  • Negative response to PDE5-I (unable to penetrate on demand even with maximum PDE5-I dosage,Non-responders)
  • Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

  • Psychogenic ED
  • Neurological pathology
  • Hormonal pathology
  • Past radical prostatectomy
  • Recovering from cancer during last 5 years
  • 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
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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): NCT01814852


Locations
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Israel
Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Initia
Investigators
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Principal Investigator: Uri Gur, M.D.
More Information
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Publications:

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Responsible Party: Initia
ClinicalTrials.gov Identifier: NCT01814852    
Other Study ID Numbers: RENO-006B-MR
First Posted: March 20, 2013    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015
Keywords provided by Initia:
Low Intensity Shockwave
Extracorporeal shockwave therapy
Erectile dysfunction
Additional relevant MeSH terms:
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Erectile Dysfunction
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
 Sexual Dysfunction, Physiological
Male Urogenital Diseases
Sexual Dysfunctions, Psychological
Mental Disorders