A Single Arm Study of Extracorporeal Shockwave Therapy for Management of Erectile Dysfunct
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 Dysfu
| Condition(s) | Erectile Dysfunction |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 | Inclusion Criteria: 1. Patient is over the age of 18 2. Patient has a natal penis (not a neophallus) 3. Patient has ED (defined as IIEF-EF of 25 or less) and EHS \< 2 on at least 50% of sexual encounters 4. Patient understands and is able to articulate necessary study procedures and tests 5. Patient has the mental capacity to provide written and verbal informed consent 6. Patient endorses the ability to comply with study procedures throughout the duration of the study Exclusion Criteria: 1. Placement of a penile prosthesis (malleable or inflatable type) 2. 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 3. Untreated severe psychological disease (e.g., psychosis, bipolar |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | University of California, San Francisco |
| Locations | San Francisco, California, United States |
| Start date | 2024-09-10 |
| NCT ID | NCT07592533 |
| Official listing | https://clinicaltrials.gov/study/NCT07592533 |