LI-SWT for Erectile Dysfunction: A single-arm study at UCSF
Official title: A Single Arm Study of EXtracorporeal Shockwave Therapy for mAnagement of ereCtile dYsfunction (EXSTACY Study)
Run by University of California, San Francisco · NCT07592533 · Data updated 2026-11-12
This study tests whether light intensity shockwave therapy can help men with erectile dysfunction and aims to see which patients are likely to benefit.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 157 (estimated) |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Status | Recruiting |
| Started | September 10, 2024 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | May 18, 2026 |
| Trial ID | NCT07592533 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 and older with a natal penis and ED (IEF-EF ≤25, EHS <2 on ≥50% of sexual attempts) who can consent and comply with procedures.
✕Probably not a fit
Patients with penile prosthesis, certain serious illnesses, or untreated major psychiatric conditions may be less likely to benefit or participate safely.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-arm device study evaluating the use of the UroGold100 shockwave device to treat erectile dysfunction. Eligible adults with a natal penis and ED (as defined by IIEF-EF ≤25 and EHS <2 on half of sexual encounters) will receive six sessions of LI-SWT to the penis and perineum, along with baseline assessments and follow-up questionnaires at 3, 6, and 12 months. The study collects baseline data, including questionnaires, blood tests, and EndoPAT endothelial function testing to identify predictors of a favorable outcome. Safety monitoring includes adverse event reporting during treatment and follow-up visits. Primary outcomes focus on feasibility and predictors of response rather than a comparative efficacy conclusion.
Why it matters
Potential benefit: If successful, it could help identify which men with ED may benefit from LI-SWT and guide treatment decisions.
How similar studies have gone: Prior studies have suggested some benefit with shockwave therapy for ED, but results vary and this study emphasizes predicting responders.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
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University of California, San Francisco (UCSF)
San Francisco, California, United States Recruiting
Study contacts
- Principal investigator: Alan W. Shindel, MD, MAS — University of California, San Francisco
- Study coordinator: Karina Acevedo, Clinical Research Coordinator
- Email: Karina.Acevedo@ucsf.edu
- Phone: 415-353-7615
Similar studies
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Piezoelectric Low-Intensity Shockwave Therapy for erectile dysfunction in PDE5i nonresponders
This study tests whether four weeks of low‑intensity, linear piezoelectric shockwave therapy can improve erectile function in men with ED who did not respond to PDE5 inhibitors.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.