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NCT03067987 · ClinicalTrials.gov registry record · NA
Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction
A NA study, sponsored by University of Miami.
- Completed
- Registry status
- NA
- Development phase
- 103
- Enrollment target
NCT03067987: Completed NA study, sponsored by University of Miami.
NCT03067987 is a NA study that has completed, run by University of Miami. The registered enrollment target is 103 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03067987, a NA study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- NA
- Development phase
- 103 participants
- Enrollment target
Study 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.
Primary Outcome
IIEF is a 15 item self-administered questionnaire assessing erectile dysfunction and treatment outcomes. Total IIEF score range from 5-25 with scores classifying erectile dysfunction (ED) as: severe (5-7); moderate (8-11); mild to moderate (12-16); mild (17-21) and no ED (22-25). The questionnaire will be assessed at baseline (before 1 month washout prior to treatment initiation), 1 month follow up (at 2 months), 3 month follow up (at 4 months) and 6 months follow up (at 7 months). Time Frame:
Interventions
- DEVICE Low Intensity Linear Shockwave Device for the Treatment of Erectile Dysfunction.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2017-02-22 |
| Est. Completion | 2019-05-28 |
| Phase | NA |
What the finished NCT03067987 record still lists
NCT03067987 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Low Intensity Linear Shockwave Device for the Treatment of Erectile Dysfunction. is the first listed.
NCT03067987 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03067987 about?
NCT03067987 is a clinical study titled "Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction". 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 eff...
What is the current status of trial NCT03067987?
This trial is currently completed. It is a NA study. The enrollment target is 103 participants. The study started on 2017-02-22. Estimated completion is 2019-05-28.
What interventions are being tested in trial NCT03067987?
The interventions under investigation include: Low Intensity Linear Shockwave Device for the Treatment of Erectile Dysfunction. (DEVICE).
Who is sponsoring clinical trial NCT03067987?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03067987's enrollment target sits among peer trials
103 837th of 2000 higher than 1,164 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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