Erectile Dysfunction
Conditions
Keywords
Erectile dysfunction, Shockwave therapy, Single-arm study
Brief 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.
Detailed description
Upon signed informed consent, an eligible patient participant with ED is enrolled in the study. Each patient will be asked to complete a series of questionnaires, blood tests, and a non-invasive assessment of blood vessel function using a device called EndoPAT at the initial Baseline Visit. The patients will receive a series of 6 LI-SWT sessions administered to the penis and perineum (the area between the scrotum and anus). A brief survey to assess for any adverse reactions/events will be asked between treatment sessions and follow-up time points at 3, 6, and 12 months from the date of the initial Baseline Visit. Additionally, patients will complete another set of questionnaires at 3, 6, and 12 months from the date of the initial Baseline Visit. EndoPAT® (Itamar Medical Inc., Atlanta, GA) is an FDA-cleared device designed for the non-invasive assessment of endothelial function and overall arterial health. EndoPAT has been used in prior studies as a way to understand blood flow in men with ED. EndoPAT testing takes about 15-25 minutes and involves assessment of blood flow in the fingers after release of a blood pressure cuff that is tightly applied around the arm. The UroGold100™ (Tissue Regeneration Technologies, Kennesaw, Georgia, USA) shockwave device will be used for this study. UroGold100™ is a patented shockwave generator that has been used in clinical practice at numerous centers around the country. A standardized protocol for SWT using this device has been patented as well. The device is cleared by the FDA for activation of connective tissue, improved blood supply, and temporary relief of pain. LI-SWT using the Urogold100™ protocol takes about 15 minutes and involves application of shockwave energy to the shaft of the penis and the perineum (area between scrotum and anus) on both sides.
Interventions
DEVICEShockwave therapy
The UroGold100™ (Tissue Regeneration Technologies, Kennesaw, Georgia, USA) shockwave device will be used for this study.
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single arm study where all eligible patients will receive the treatment.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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 disorder)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 3 months post-treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detect clinically meaningful change in IIEF-EFD score for ED: mild, moderate, and severe; which corresponds to 2, 5, and 7 points change, respectively. | 3 months post-treatment | 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. | 6-months post treatment; 12-months post treatment | 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? | 3 months; 6 months; and 12 months (post-treatment) | 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. |
Countries
United States
Contacts
CONTACTKarina Acevedo, Clinical Research Coordinator
CONTACTJennette Sison, MPH
PRINCIPAL_INVESTIGATORAlan W. Shindel, MD, MAS
University of California, San Francisco
Outcome results
None listed