RecruitingNot ApplicableNCT07592533

A Single Arm Study of Extracorporeal Shockwave Therapy for Management of Erectile Dysfunction

A Single Arm Study of EXtracorporeal Shockwave Therapy for mAnagement of ereCtile dYsfunction (EXSTACY Study)

Sponsor

University of California, San Francisco

Enrollment

157 participants

Start Date

Sep 10, 2024

Study Type

INTERVENTIONAL

Conditions

Erectile Dysfunction

Summary

This is a device study (while the device has been patented and cleared by the FDA, the indication of the use for Erectile Dysfunction has been yet approve). EXSTACY is a study to collect information on which patients who have trouble getting or keeping an erection rigid enough for sex (sometimes known as Erectile Dysfunction or ED) benefit from light intensity shockwave therapy (LI-SWT). LI-SWT is a form of energy transfer to the penis that has been shown to help some men with ED in studies over the past decade. This study will collect information about patients prior to treatment to determine what predicts a good outcome. The investigators hope that this information will help decide which patients are likely to benefit from LI-SWT and which patients should consider other treatments for ED.

Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria6

Patient is over the age of 18
Patient has a natal penis (not a neophallus)
Patient has ED (defined as IIEF-EF of 25 or less) and EHS < 2 on at least 50% of sexual encounters
Patient understands and is able to articulate necessary study procedures and tests
Patient has the mental capacity to provide written and verbal informed consent
Patient endorses the ability to comply with study procedures throughout the duration of the study

Exclusion Criteria3

Placement of a penile prosthesis (malleable or inflatable type)
Have a serious medical condition/illness that makes safety or compliance with study procedures and/or engagement in sexual activity inadvisable in the opinion of the PI
Untreated severe psychological disease (e.g., psychosis, bipolar disorder)

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