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Linear Focused Shockwave Treatment for 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: NCT02152683
Recruitment Status : Terminated
First Posted : June 2, 2014
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
Initia

Brief Summary:
The study is aimed at comparing the performance of protocols employing one and two sessions per week, respectively. The study hypothesis claims that there is no significant difference between the performances of the compared protocols.

Condition or disease Intervention/treatment Phase
Vasculogenic Erectile Dysfunction Device: Renova Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Linear Focused Shockwave Treatment for Erectile Dysfunction
Study Start Date : March 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: long protocol
Renova
Device: Renova
Low- Intensity Shockwave

Experimental: short protocol
Renova
Device: Renova
Low- Intensity Shockwave




Primary Outcome Measures :
  1. IIEF-EF- International Index of Erectile Function questionnaire score [ Time Frame: 1 month post treatment ]
    the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment

  2. IIEF-EF questionnaire score [ Time Frame: 3 months post treatment ]
  3. IIEF-EF questionnaire score [ Time Frame: 6 months post treatment ]
    the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment


Secondary Outcome Measures :
  1. SEP- Sexual Encounter Profile: Questions 2 and 3 [ Time Frame: 1, 3 and 6 months post treatment ]
  2. GAQ- Global Assessment Questions [ Time Frame: 1, 3 and 6 months post treatment ]
  3. EHS- Erection Hardness Score [ Time Frame: 1, 3 and 6 months post treatment ]


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.


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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:

  1. Good general health
  2. Vasculogenic ED- Erectile Dysfunction, according to physician judgment, for at least 6 months and for no longer than 5 years.
  3. International Index of Erectile Function 6 (IIEF-EF) between 17 and 25
  4. Satisfactory response to the use of PDE5 (Phosphodiesterase type 5) inhibitors
  5. Stable sexual relationship for at least 3 months prior to treatment
  6. Minimum of two sexual attempts per month

Exclusion Criteria:

  1. Hormonal, neurological or psychological pathology
  2. Past radical prostatectomy or extensive pelvic surgery
  3. Recovering from cancer during last year
  4. Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities
  5. Clinically significant chronic hematological disease
  6. Anti-androgens, oral or injectable androgens
  7. Past radiotherapy treatment of the pelvic region
  8. International normalized ratio (INR) > 3 for patients using blood thinners (such as Coumadin)

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): NCT02152683


Locations
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United States, New York
Eastchester Center for Cancer Care
New york, New York, United States, 10469
Sponsors and Collaborators
Initia
Publications:
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Responsible Party: Initia
ClinicalTrials.gov Identifier: NCT02152683    
Other Study ID Numbers: LISW-NY
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders