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

May 11, 2026 updated by: University of California, San Francisco

A Single Arm Study of EXtracorporeal Shockwave Therapy for mAnagement of ereCtile dYsfunction (EXSTACY Study)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

157

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco (UCSF)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Shockwave therapy
Once a week for 6 weeks
Device: Shockwave therapy
The UroGold100™ (Tissue Regeneration Technologies, Kennesaw, Georgia, USA) shockwave device will be used for this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
3 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detect clinically meaningful change in IIEF-EFD score for ED: mild, moderate, and severe; which corresponds to 2, 5, and 7 points change, respectively.
Time Frame: 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.
3 months post-treatment
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.
Time Frame: 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.
6-months post treatment; 12-months post treatment
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?
Time Frame: 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.
3 months; 6 months; and 12 months (post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Alan W. Shindel, MD, MAS, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 29, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-39009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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