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.
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
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)
Single group
Shockwave therapy
DeviceThe UroGold100™ (Tissue Regeneration Technologies, Kennesaw, Georgia, USA) shockwave device will be used for this study.
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
Compare IIEF-EFD score at Baseline with IIEF-EFD score reported at 3-months (post-treatment) to see if there is a change of 4 points which corresponds to significant improvement in erectile function.
Detect clinically meaningful change in IIEF-EFD score for ED: mild, moderate, and severe; which corresponds to 2, 5, and 7 points change, respectively.
Compare IIEF-EFD score at Baseline with IIEF-EFD score reported at 3-months (post-treatment) to detect a change in the severity of ED. The IIEF-EFD is divded into severity scores, with 25+ (normal); 18-24 (mild); 11-17 (moderate), and \<10 (severe). A clinically significant improvement for each category will be 2 points for mild; 5 points for moderate; and 7 points for severe ED when comparing IIEF-EFD scores at 3-months post treatment with Baseline scores.
Review IIEF-EFD scores at later time-points to check if the change in score remains consistent. This may indicate a durability (lasting effect) of ED improvement over time.
Compare IIEF-EFD score at Baseline with IIEF-EFD score reported at 6-months and 12-months post treatment to detect if the change in points remains consistent; with a 4-point change indicating significant improvement of ED over time.
Is there clinically noticeable ED improvement detected by a change of 4 points in the IIEF-EFD score between men who had radical prostatectomy (RP) or radiation therapy versus men who did not receive RP or radiation therapy?
Compare the IIEF-EFD scores at Baseline and time-points: 3-mo, 6-mo, and 12-mo in men who received RP or radiation therapy to see if there is a change of 4 points at the three later time-points. Calculate the IIEF-EFD in men who did not receive RP or radiation therapy at the same time-points to see if there is a difference.
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