At a glance
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Safety and Efficacy of Low Intensity Shockwave for the Treatment of Erectile Dysfunction- Comparison of Two Treatment Schedule
In Brief
A clinical study evaluating Low Intensity Linear Shockwave Device for the Treatment of Erectile Dysfunction. for Vasculogenic Erectile Dysfunction. Completed, enrolled 103 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on symptomatic erectile dysfunction patients. The patients are randomized in a 1:1 ratio into two active treatment groups. Group A: 5 daily sessions within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura). Group B: Three sessions per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura) .