Study of the Double-S Wearable Device for Erectile Dysfunction

This study is testing a wearable device called Double-S for men who experience erectile dysfunction (ED). This includes men with ED from various causes, such as after prostate cancer treatment, or due to vascular or metabolic issues. The goal is to see if the Double-S device can help you achieve satisfactory erections for intercourse without medication. The study will measure success by looking at changes in your International Index of Erectile Dysfunction score, which is a questionnaire about erectile function. This study is currently recruiting about 10 male participants who are over 18 years old.

Study design
This study is testing a device called Double-S in about 10 male participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your erectile function will be assessed at the start of the study and up to 1 month after you begin using the device.

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NCT05451563

Double-S: a Wearable Device for Erectile Dysfunction

Recruiting
NAAges 18+Interventional
Stanford University
~10 participants
Updated 2025-05-22 on ClinicalTrials.gov
What's tested:Double-S

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in modified International Index of Erectile Dysfunction score
Measured over baseline and up to 1 month post-baseline
Erectile Dysfunction
1 sites across 1 states
California1
  • Michael Eisenberg, MD · PRINCIPAL_INVESTIGATOR · Stanford University

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

not willing to attempt sexual vaginal intercourse with their partner
inability to wear/operate the external penile device for any reason
  • Change in modified International Index of Erectile Dysfunction scorebaseline and up to 1 month post-baseline

    score 0 to 30 with higher score meaning better erectile function