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Safety and Efficacy Associated With Treating Erectile Dysfunction Patients With Low Intensity Shockwaves by Renova

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: NCT01811797
Recruitment Status : Terminated
First Posted : March 15, 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 comparing safety and efficacy of the treatments performed with the Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) device - "Renova" on symptomatic ED patients to the safety and efficacy of the control sham patients.

Condition or disease Intervention/treatment Phase
Vasculogenic Erectile Dysfunction Device: Low Intensity Shockwave by Renova Device: Sham treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 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 Associated With Treating Patients Suffering From Erectile Dysfunction With Low Intensity Shockwaves by Renova
Study Start Date : October 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Low Intensity Shockwave treatment
4 weekly sessions of Low Intensity Shockwave treatment.
 Device: Low Intensity Shockwave by Renova
Sham Comparator: Control group Device: Sham treatment
Sham treatment that looks, sounds and feels like the real LISW treatment.


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 3 and 6 months post treatment [ Time Frame: 1, 3 and 6 months post treatment ]

Secondary Outcome Measures :
  1. Change from baseline in the SEP (Sexual Encounter Profile) Questions 2 and 3 at 3 and 6 months post treatment [ Time Frame: 1, 3 and 6 months post treatment ]
  2. Change from baseline in the GAQ (Global Assessment Questions) at 3 and 6 months post treatment [ Time Frame: 1, 3 and 6 months post treatment ]
  3. Change from baseline in the EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment [ Time Frame: 1, 3 and 6 months post treatment ]
  4. Change from baseline in the Partner EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment [ Time Frame: 1, 3 and 6 months post treatment ]
  5. Change from baseline in the IPSS (International Prostate Symptom Score) at the end of the treatment [ Time Frame: 0 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
  • Vascular 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:

  • Hormonal, neurological or psychological pathology
  • Past radical prostatectomy or extensive pelvic surgery
  • 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
  • Past radiotherapy treatment of the pelvic region
  • International normalized ratio (INR) > 3 for patients using blood thinners (such as Coumadin)
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): NCT01811797


Locations
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Israel
The Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel
Sponsors and Collaborators
Initia
More Information
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Publications:

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Responsible Party: Initia
ClinicalTrials.gov Identifier: NCT01811797    
Other Study ID Numbers: RENO-03-ICH
First Posted: March 15, 2013    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015
Keywords provided by Initia:
Erectile Dysfunction
Extracorporeal shockwave
Low intensity shockwaves
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders