An interventional study of Low-intensity acoustic shockwave therapy in Erectile Dysfunction, sponsored by Northwell Health. Enrolling by invitation at 2 sites in United States. Open to male participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-16.
Sponsored by Northwell Health · Not applicable, Interventional, and Treatment
Patients presenting with erectile dysfunction are often found to have increased corporal firmness on elastography. We hypothesize that this corporal firmness reflects reversable changes that can be altered by Low-Intensity Shockwave Therapy (LiST). In this pilot study patients found to have increased corporal firmness will be treated with LiST.
This study will enroll men between the ages of 18 and 65 with corporal cavernosal firmness on elastography. The participants study duration is 3 months long and includes eight visits at the study center. Study visits consist of physical exam, vital signs, questionnaires, blood draws, and administration of low-intensity shockware therapy (LiST).
Low intensity extracorporeal (i.e., outside the body) shockwave therapy (LiST) is a treatment that has been in use since 2010 and has become commonly used Internationally and in the United States since 2015. The device applies a low-intensity shockwave to the surface of the penis using an ultrasound gel as the coupling agent.
The study will evaluate changes in corporal cavernosal firmness and changes in penile vascular blood flow.
683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.
This study's planned enrollment of 20 is below the median of 72 across 542 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →Northwell Health is the lead sponsor of 463 studies on the registry; 109 are open to participants now.
Of its 40 completed or terminated interventional studies of FDA-regulated products, 20 (50%) have results posted.
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The device applies a low-intensity shockwave to the surface of the penis using an ultrasound gel as the coupling agent. The low-intensity shockwave therapy device will be used with the purpose of improving penile blood flow and restoring sexual function in men with impaired erectile function.
Device: Low-intensity acoustic shockwave therapy
The study is being done to find out if low-intensity shockwave therapy can improve penile blood flow and restore sexual function in men with impaired erectile function.
Evaluate changes in corporal cavernosal firmness with Low-Intensity Acoustic Shockwave Therapy (LiST)
Change in corporal firmness (KPa) with Low-Intensity Acoustic Shockwave Therapy (LiST)
Time frame: 12 Weeks
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