Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
Renova- Erectile Dysfunction (ED) is a Linear Shockwaves (LISW) device which incorporates a
unique shockwave transducer operable to deliver shockwaves to a treated region. Shockwaves
are aimed at the left and right corpora cavernosa and the crura. The study is aimed at
determining the safety and effectiveness of this new type LISW in the relief of erectile
dysfunction.
HYPOTHESIS Alternate Hypothesis (HA): Active Treatment groups will show a >2-point increase
in the IIEF-EF score from baseline for mild erectile dysfunction, and >5 points for moderate
erectile dysfunction and will show significant change.
Null Hypothesis (HO): There is no difference from baseline and after-treatment in Treatment
groups for alleviating erectile dysfunction measured using International Index of Erectile
Function score (IIEF-EF).
Primary Efficacy Objective: To evaluate change of International Index of Erectile Function
score Questionnaire score from baseline to follow-ups 1, 3 and 6 months' post treatment.
Secondary Objectives:To study sexual activity improvement leading to optimal penetration at
follow-ups according to:
- SEP- Sexual Encounter Profile Questionnaire.
- GAQ- Global Assessment Questionnaire.
- EHS- Erection Hardness Score.
Phase
N/A
Funding Agency/Sponsor
Other
Disease
Other
Enrollment Eligibility
Inclusion Criteria:
- The patient must be willing and able to provide informed consent.
- The patient is a male between >30 and <80 years of age.
- PDE5i responsive or non-responsive. If on PDE5i patient will discontinue medication
for 4 weeks before IIEF.
- Stable sexual relationship for over 3 months prior to enrollment.
- A minimum of 2 sexual attempts per month for at least one month prior to enrollment.
- Erectile dysfunction lasting for over 6 months and not more than 5 years.
- Baseline IIEF-EF score between 11 and 25. If taking PDE5i, stop medication for at
least 4 weeks before baseline IIEF-EF.
- Testosterone level 300-1000 ng/dL.
- If diabetic, HgbA1C level ≤ 7.5% within 1 month prior to enrollment.
Exclusion Criteria:
- The patient is currently or has participated in another study within the past three
months, that may interfere with the results or conclusions of this study.
- The patient is under judicial protection (prison or custody).
- The patient is an adult under guardianship.
- The patient refuses to sign the consent.
- History of radical prostatectomy or extensive pelvic surgery ever.
- Past radiation therapy of the pelvic region within 12 months prior to enrollment.
- Recovering from any cancer within 12 months prior to enrollment.
- Neurological disease such as Alzheimers or Parkinsons disease which affects erectile
function at the discretion of the investigator.
- Psychiatric diagnosis or medications such as antidepressants which affects erectile
function or any other medications at the discretion of the investigator.
- Anatomical malformation of the penis, including Peyronie's disease.
- Testosterone level <300 or >1000 ng/dL within 1 month prior to enrollment.
- HgbA1C level > 7.5% within 1 month prior to enrollment.
- Androgen deprivation treatment in the last year.
- History of spinal cord injury.
- The patient is taking blood thinners (eg Coumadin, Plavix)