Back to resultsSafety and Efficacy Associated With Treating Erectile Dysfunction Patients With Low Intensity Shockwaves by Renova
Primary Purpose
Vasculogenic Erectile Dysfunction
Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Low Intensity Shockwave by Renova
Sham treatment
Sponsored by
About this trial
This is an interventional treatment trial for Vasculogenic Erectile Dysfunction focused on measuring Erectile Dysfunction, Extracorporeal shockwave, Low intensity shockwaves
Eligibility 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)
Sites / Locations
- The Tel-Aviv Sourasky Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Low Intensity Shockwave treatment
Control group
Arm Description
4 weekly sessions of Low Intensity Shockwave treatment.
Outcomes
Primary Outcome Measures
Change from baseline in the IIEF-EF (International Index of Erectile Function- Erectile Function Domain) score at 3 and 6 months post treatment
Secondary Outcome Measures
Change from baseline in the SEP (Sexual Encounter Profile) Questions 2 and 3 at 3 and 6 months post treatment
Change from baseline in the GAQ (Global Assessment Questions) at 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
Change from baseline in the Partner EDITS (Erectile Dysfunction Inventory of Treatment Satisfaction) score at 3 and 6 months post treatment
Change from baseline in the IPSS (International Prostate Symptom Score) at the end of the treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01811797
Brief Title
Safety and Efficacy Associated With Treating Erectile Dysfunction Patients With Low Intensity Shockwaves by Renova
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 Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Initia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasculogenic Erectile Dysfunction
Keywords
Erectile Dysfunction, Extracorporeal shockwave, Low intensity shockwaves
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Intensity Shockwave treatment
Arm Type
Experimental
Arm Description
4 weekly sessions of Low Intensity Shockwave treatment.
Arm Title
Control group
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Low Intensity Shockwave by Renova
Intervention Type
Device
Intervention Name(s)
Sham treatment
Intervention Description
Sham treatment that looks, sounds and feels like the real LISW treatment.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
Change from baseline in the IPSS (International Prostate Symptom Score) at the end of the treatment
Time Frame
0 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
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)
Facility Information:
Facility Name
The Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
Country
Israel
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
22425129
Citation
Vardi Y, Appel B, Kilchevsky A, Gruenwald I. 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. J Urol. 2012 May;187(5):1769-75. doi: 10.1016/j.juro.2011.12.117. Epub 2012 Mar 15.
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
Safety and Efficacy Associated With Treating Erectile Dysfunction Patients With Low Intensity Shockwaves by Renova
We'll reach out to this number within 24 hrs