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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

Tracking Information
First Submitted Date  ICMJE March 13, 2013
First Posted Date  ICMJE March 15, 2013
Last Update Posted Date May 12, 2015
Study Start Date  ICMJE October 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2013)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2013)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Change from baseline in the IPSS (International Prostate Symptom Score) at the end of the treatment [ Time Frame: 0 and 6 months post treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Associated With Treating Erectile Dysfunction Patients With Low Intensity Shockwaves by Renova
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Vasculogenic Erectile Dysfunction
Intervention  ICMJE
  • Device: Low Intensity Shockwave by Renova
  • Device: Sham treatment
    Sham treatment that looks, sounds and feels like the real LISW treatment.
Study Arms  ICMJE
  • Experimental: Low Intensity Shockwave treatment
    4 weekly sessions of Low Intensity Shockwave treatment.
    Intervention: Device: Low Intensity Shockwave by Renova
  • Sham Comparator: Control group
    Intervention: Device: Sham treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 11, 2015)
2
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2013)
40
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01811797
Other Study ID Numbers  ICMJE RENO-03-ICH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Initia
Study Sponsor  ICMJE Initia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Initia
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP