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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07592533
Status
Recruiting
Apply to this trial

Conditions

  • Erectile Dysfunction

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Shockwave therapy — DEVICE
    The UroGold100™ (Tissue Regeneration Technologies, Kennesaw, Georgia, USA) shockwave device will be used for this study.

Study Details

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.

Key Dates

Start date
Sep 10, 2024
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
157 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Shockwave therapy
    Once a week for 6 weeks

Primary Outcome Measure

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 [ Time Frame: 3 months post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San Francisco (UCSF)San FranciscoCalifornia94143
Alan W. Shindel, MD, MAS
[email protected]
415-353-2200

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By research site
University of California, San Francisco (UCSF)· San Francisco, CA

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