Status:
TERMINATED
Safety and Efficacy Associated With Treating Erectile Dysfunction Patients With Low Intensity Shockwaves by Renova
Lead Sponsor:
Initia
Conditions:
Vasculogenic Erectile Dysfunction
Eligibility:
MALE
20-80 years
Phase:
NA
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 - "Ren...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01811797
Start Date
October 1 2013
End Date
June 1 2014
Last Update
May 12 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel