Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction

Completed · Not applicable

Conditions studied: Vasculogenic Erectile Dysfunction

In brief

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.

Key facts

Study ID

NCT03067987

Run by

University of Miami

People needed

103

Starts

2017-02-22

Expected to finish

2019-05-28

Last updated by the study team

2020-06-11

Who can join

Age: 30 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.