A Single Arm Study of Extracorporeal Shockwave Therapy for Management of Erectile Dysfunction (NCT07592533) | Clinical Trial Compass
RecruitingNot Applicable
A Single Arm Study of Extracorporeal Shockwave Therapy for Management of Erectile Dysfunction
United States157 participantsStarted 2024-09-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinically noticeable improvement of ED detected by a change of 4 points in the International Index of Erectile Dysfunction - Erectile Function Domain score or IIEF-EFD score
. 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)