Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction
Public ClinicalTrials.gov record NCT03067987. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction- Comparison of Two Treatment Schedule
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03067987
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 103 participants
Conditions and interventions
Conditions
Interventions
Device
Eligibility (public fields only)
- Age range
- 30 Years to 80 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 21, 2017
- Primary completion
- May 21, 2019
- Completion
- May 27, 2019
- Last update posted
- Jun 10, 2020
2017 – 2019
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03067987, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 10, 2020 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03067987 live on ClinicalTrials.gov.