N/A
N=103
Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction
Vasculogenic Erectile Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT03067987 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: International Index of Erectile Function (IIEF-EF) Questionnaire — 18; 17.9; 20.5; 19.7 score on a scale — p=<0.007
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low Intensity Linear Shockwave Device for the Treatment of Erectile Dysfunction. (Device)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- Male
- Sponsor
- University of Miami
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY International Index of Erectile Function (IIEF-EF) Questionnaire |
18; 17.9; 20.5; 19.7; 19.8; 21.2 | <0.007 sig |
| SECONDARY Erection Hardness Score (EHS) |
2.5; 2.7; 3.1; 3; 3.1; 3 | 0.0006 sig |
| SECONDARY Sexual Encounter Profile (SEP) |
96; 95; 4; 5; 69; 70 | — |
| SECONDARY Global Assessment Question (GAQ) |
52; 53; 48; 47; 74; 73 | — |
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.
Eligibility Criteria
Inclusion Criteria
- The patient must be willing and able to provide informed consent.
- The patient is a male between >30 and 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)
Data sourced from ClinicalTrials.gov (NCT03067987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.