Linear Focused Shockwave Treatment for Erectile Dysfunction
Primary Purpose
Vasculogenic Erectile Dysfunction
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Renova
Sponsored by
About this trial
This is an interventional treatment trial for Vasculogenic Erectile Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Good general health
- Vasculogenic ED- Erectile Dysfunction, according to physician judgment, for at least 6 months and for no longer than 5 years.
- International Index of Erectile Function 6 (IIEF-EF) between 17 and 25
- Satisfactory response to the use of PDE5 (Phosphodiesterase type 5) inhibitors
- Stable sexual relationship for at least 3 months prior to treatment
- Minimum of two sexual attempts per month
Exclusion Criteria:
- Hormonal, neurological or psychological pathology
- Past radical prostatectomy or extensive pelvic surgery
- Recovering from cancer during last year
- 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)
Sites / Locations
- Eastchester Center for Cancer Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
long protocol
short protocol
Arm Description
Renova
Renova
Outcomes
Primary Outcome Measures
IIEF-EF- International Index of Erectile Function questionnaire score
the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment
IIEF-EF questionnaire score
IIEF-EF questionnaire score
the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment
Secondary Outcome Measures
SEP- Sexual Encounter Profile: Questions 2 and 3
GAQ- Global Assessment Questions
EHS- Erection Hardness Score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02152683
Brief Title
Linear Focused Shockwave Treatment for Erectile Dysfunction
Official Title
Linear Focused Shockwave Treatment for Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Initia
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasculogenic Erectile Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
long protocol
Arm Type
Experimental
Arm Description
Renova
Arm Title
short protocol
Arm Type
Experimental
Arm Description
Renova
Intervention Type
Device
Intervention Name(s)
Renova
Intervention Description
Low- Intensity Shockwave
Primary Outcome Measure Information:
Title
IIEF-EF- International Index of Erectile Function questionnaire score
Description
the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment
Time Frame
1 month post treatment
Title
IIEF-EF questionnaire score
Time Frame
3 months post treatment
Title
IIEF-EF questionnaire score
Description
the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment
Time Frame
6 months post treatment
Secondary Outcome Measure Information:
Title
SEP- Sexual Encounter Profile: Questions 2 and 3
Time Frame
1, 3 and 6 months post treatment
Title
GAQ- Global Assessment Questions
Time Frame
1, 3 and 6 months post treatment
Title
EHS- Erection Hardness Score
Time Frame
1, 3 and 6 months post treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Good general health
Vasculogenic ED- Erectile Dysfunction, according to physician judgment, for at least 6 months and for no longer than 5 years.
International Index of Erectile Function 6 (IIEF-EF) between 17 and 25
Satisfactory response to the use of PDE5 (Phosphodiesterase type 5) inhibitors
Stable sexual relationship for at least 3 months prior to treatment
Minimum of two sexual attempts per month
Exclusion Criteria:
Hormonal, neurological or psychological pathology
Past radical prostatectomy or extensive pelvic surgery
Recovering from cancer during last year
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)
Facility Information:
Facility Name
Eastchester Center for Cancer Care
City
New York
State/Province
New York
ZIP/Postal Code
10469
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20451317
Citation
Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010 Aug;58(2):243-8. doi: 10.1016/j.eururo.2010.04.004. Epub 2010 May 6.
Results Reference
background
PubMed Identifier
22999553
Citation
Goyal NK, Garg M, Goel A. Re: Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study: Y. Vardi, B. Appel, A. Kilchevsky and I. Gruenwald. J Urol 2012; 187: 1769-1775. J Urol. 2012 Nov;188(5):2018-9. doi: 10.1016/j.juro.2012.07.052. Epub 2012 Sep 20. No abstract available.
Results Reference
background
PubMed Identifier
12152111
Citation
Rosen RC, Cappelleri JC, Gendrano N 3rd. The International Index of Erectile Function (IIEF): a state-of-the-science review. Int J Impot Res. 2002 Aug;14(4):226-44. doi: 10.1038/sj.ijir.3900857.
Results Reference
background
PubMed Identifier
21855209
Citation
Rosen RC, Allen KR, Ni X, Araujo AB. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. Eur Urol. 2011 Nov;60(5):1010-6. doi: 10.1016/j.eururo.2011.07.053. Epub 2011 Jul 30.
Results Reference
background
Learn more about this trial
Linear Focused Shockwave Treatment for Erectile Dysfunction
We'll reach out to this number within 24 hrs