Actively Recruiting
Double-S: a Wearable Device for Erectile Dysfunction
Led by Stanford University · Updated on 2025-05-22
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate a minimally invasive wearable device designed to support men suffering from erectile dysfunction, including those with conditions such as post-prostatectomy or radiation therapy, vascular or metabolic causes, and psychological factors. The study focuses on providing a mechanical, medication-free option to help patients achieve satisfactory sexual penetration. Participants will be asked to use the Double-S wearable penile device during intercourse. This device is intended to offer support without medication, helping men with moderate to severe erectile dysfunction to engage in sexual activity. The study does not involve a control or placebo group and is open-label. During the study, researchers will assess changes in erectile function using a modified International Index of Erectile Dysfunction score from baseline up to one month after starting the device use. Participants will be monitored and evaluated based on their ability to use the device and achieve satisfactory intercourse. The total study duration and follow-up details are aligned with this assessment period.
CONDITIONS
Brief Title
Double-S: a Wearable Device for Erectile Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants older than 18 years
- Moderate to severe erectile dysfunction from any cause (e.g., after prostate cancer treatment, vascular, metabolic, or psychological causes)
- Having a female partner willing to participate in the study
You will not qualify if you...
- Not willing to attempt sexual vaginal intercourse with their partner
- Unable to wear or operate the external penile device for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 month post-baseline
Participants will use the wearable penile device during intercourse to provide mechanical support for erectile function.
Trial Site Locations
Total: 1 location
1
Stanford Healthcare, Stanford Hospital
Stanford, California, United States, 94304
Actively Recruiting
Research Team
S
Satvir Basran
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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