Wearable device for erectile dysfunction
Official title: Double-S: a Wearable Device for Erectile Dysfunction
Run by Stanford University · NCT05451563 · Data updated 2026-11-12
This study is testing a new wearable device to help men with erectile dysfunction have better sexual experiences without using medication.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 10 (estimated) |
| Sponsor | Stanford University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Stanford, California) |
| Status | Recruiting |
| Started | March 21, 2024 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | May 22, 2025 |
| Trial ID | NCT05451563 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are males over 18 years old experiencing moderate to severe erectile dysfunction from various causes, including post-cancer treatment.
✕Probably not a fit
Patients who are not willing to attempt sexual intercourse or cannot operate the device will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate a minimally invasive wearable device designed to assist men suffering from erectile dysfunction in achieving satisfactory sexual intercourse. The device provides mechanical support to facilitate penetration without the need for medication. It targets men with various causes of erectile dysfunction, including those who have undergone prostate cancer treatments or have other underlying health issues. Participants will be monitored to assess the effectiveness and usability of the device during sexual activity.
Why it matters
Potential benefit: If successful, this device could offer a medication-free solution for men struggling with erectile dysfunction, improving their sexual health and quality of life.
How similar studies have gone: While there have been various approaches to treating erectile dysfunction, the specific use of this wearable device represents a novel intervention that has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * males \>18 years old suffering from any cause moderate to severe erectile dysfunction (e.g. ED after radical prostatectomy and/or radiation therapy for prostate cancer and or other pelvic malignancies affecting the sexual potency; emotional and psychological ED; organic vascular and/or metabolic ED etc.) * having a female partner willing to participate in the study Exclusion Criteria: * not willing to attempt sexual vaginal intercourse with their partner * inability to wear/operate the external penile device for any reason
Where it's running
-
Stanford Healthcare, Stanford Hospital
Stanford, California, United States Recruiting
Study contacts
- Principal investigator: Michael Eisenberg, MD — Stanford University
- Study coordinator: Satvir Basran
- Email: sbasran@stanford.edu
- Phone: 650-723-0948
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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HIP2602 for Erectile Dysfunction: Testing a new treatment in adults
This study tests whether HIP2602, alone or with related formulations, can improve erectile function in adult men with long-standing erectile dysfunction who partner with the same adult female partner.
-
Platelet-Rich Plasma for Erectile Dysfunction After Prostate Surgery
This trial tests whether injecting a patient’s own platelet-rich plasma can improve erectile function in men who have persistent ED more than a year after nerve-sparing radical prostatectomy.
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Pudendal artery plaque and erectile dysfunction in men with heart disease
A small study tests whether plaque in the internal pudendal arteries is linked to erectile function in men with coronary artery disease who are undergoing coronary angiography.
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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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Sexual function and quality of life in monogamous vs polygamous marriages among Egyptian men
This is a web-based survey to see if marital structure affects erectile function and sexual quality of life in Egyptian men who are married.
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Lifestyle changes to improve erectile function in men with metabolic syndrome
A six-month lifestyle program is being tried to see if it improves erectile function and penile blood flow in men who have erectile dysfunction linked to metabolic syndrome.
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.