Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
ID07592533

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

Led by University of California, San Francisco · Updated on 2026-05-18

157

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research evaluates the use of low-intensity shockwave therapy (LI-SWT) as a treatment for men with erectile dysfunction (ED), a condition where it is difficult to achieve or maintain an erection firm enough for sex. The study aims to gather information on which patients benefit from this therapy to better predict outcomes and help guide treatment decisions. The device used has FDA clearance but is not yet approved specifically for ED treatment. Participants will receive six weekly sessions of LI-SWT using the UroGold100™ device, which applies shockwave energy to the penis and perineum. Before treatment, patients complete questionnaires, blood tests, and a non-invasive blood vessel function test with the EndoPAT device. Follow-up visits occur at 3, 6, and 12 months after the initial baseline visit, including additional questionnaires and safety surveys. During the study, researchers will monitor erectile function using the International Index of Erectile Dysfunction-Erectile Function Domain (IIEF-EFD) score, focusing on changes three months after treatment and durability of improvement at six and twelve months. Safety and any adverse effects will be assessed throughout. Total study participation includes baseline assessments, treatment sessions, and follow-up evaluations over one year.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is over the age of 18
  • Patient has a natal penis (not a neophallus)
  • Patient has erectile dysfunction with an IIEF-EF score of 25 or less and an erection hardness score below 2 in at least 50% of sexual encounters
  • Patient understands and can explain study procedures and tests
  • Patient has the mental ability to provide written and verbal informed consent
  • Patient agrees to follow study procedures throughout the study duration
Not Eligible

You will not qualify if you...

  • Has a penile prosthesis (malleable or inflatable)
  • Has a serious medical condition making study participation or sexual activity unsafe or difficult
  • Has untreated severe psychological disease such as psychosis or bipolar disorder

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - 6 weeks

Participants receive a series of 6 shockwave therapy sessions administered once a week for 6 weeks to the penis and perineum.

6 weekly visits (in-person) for therapy sessions with brief surveys between sessions

Follow-up

Duration - 12 months

Participants complete questionnaires and have assessments to monitor erectile function and any adverse reactions at 3, 6, and 12 months after the initial baseline visit.

3 visits at 3, 6, and 12 months (in-person or remote)

Trial Site Locations

Total: 1 location

1

University of California, San Francisco (UCSF)

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

K

Karina Acevedo, Clinical Research Coordinator

J

Jennette Sison, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Systematic Review and Meta-Analysis of 16 Randomized Controlled Trials of Clinical Outcomes of Low-Intensity Extracorporeal Shock Wave Therapy in Treating Erectile Dysfunction.

Huibao Yao, Xiaofeng Wang, Hongquan Liu...

https://pubmed.ncbi.nlm.nih.gov/35319291

Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction.

Yoram Vardi, Boaz Appel, Giris Jacob...

https://pubmed.ncbi.nlm.nih.gov/20451317

Evaluation of the effect of different doses of low energy shock wave therapy on the erectile function of streptozotocin (STZ)-induced diabetic rats.

Jing Liu, Feng Zhou, Guang-Yong Li...

https://pubmed.ncbi.nlm.nih.gov/23698784

Extracorporeal shock-wave therapy enhanced wound healing via increasing topical blood perfusion and tissue regeneration in a rat model of STZ-induced diabetes.

Yur-Ren Kuo, Chun-Ting Wang, Feng-Sheng Wang...

https://pubmed.ncbi.nlm.nih.gov/19614917