Recruiting

LI-SWT

Sponsor:

UCLA

Code:

NCT07592533

Conditions

Erectile Dysfunction

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Shockwave therapy

Study Details

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.

Conditions

Erectile Dysfunction

Study ID

NCT07592533

Start date

Sep 10, 2024

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

157 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Shockwave therapy

Once a week for 6 weeks

Interventions

Shockwave therapy

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

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 and Locations

Central contacts

Karina Acevedo, Clinical Research Coordinator

415-353-7615Karina.Acevedo@ucsf.edu

Jennette Sison, MPH

415-885-3692Jennette.Sison@ucsf.edu

Locations

University of California, San Francisco (UCSF)

Recruiting

San Francisco, California, United States, 94143

Contacts

Alan W. Shindel, MD, MAS

415-353-2200Alan.Shindel@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

  • Erectile dysfunction
  • Shockwave therapy
  • Single-arm study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-05-18.