Status:
COMPLETED
Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) by 'Renova' for Patients With Erectile Dysfunction
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 for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.
Detailed Description
This is a prospective, randomized, double-blind clinical study comparing safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients to the safety and efficacy of ...
Eligibility Criteria
Inclusion
- Good general health
- Vasculogenic 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
- Psychogenic ED
- Neurological pathology
- Hormonal pathology
- Past radical prostatectomy
- 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
- Radiotherapy in pelvic region
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01814852
Start Date
December 1 2012
End Date
February 1 2015
Last Update
May 12 2015
Active Locations (1)
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1
Meir Medical Center
Kfar Saba, Israel