Wearable device for erectile dysfunction
Double-S: a Wearable Device for Erectile Dysfunction
This study is testing a new wearable device to help men with erectile dysfunction have better sexual experiences without using medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Stanford University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT05451563 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are males over 18 years old experiencing moderate to severe erectile dysfunction from various causes, including post-cancer treatment.
Not a fit: Patients who are not willing to attempt sexual intercourse or cannot operate the device will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Stanford, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.