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Recruiting

NCT Number: NCT05451563

Double-S: a Wearable Device for Erectile Dysfunction

The purpose of this study is to use a minimally invasive erectile device for patients suffering from erectile dysfunction.

Recruiting

Interested in participating?

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Healthcare, Stanford Hospital

Stanford, California, 94304, United States

Location status: Recruiting

About this study

The purpose of the study is to use a minimally invasive erectile device support to provide to patients suffering from erectile dysfunction the possibility to achieve satisfactory penetrating intercourse.

The goal of this is to help men who have issues with erectile function (e.g.after radical prostatectomy for prostate cancer, vascular or metabolic erectile dysfunction non-responsive to phosphodiesterase-5 inhibitor medications, etc.) to have medication-free mechanical support for their penis in order to obtain sexual penetration satisfactorily.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Double-S

Device

Wearable device for intercourse

Primary outcomes

  1. Change in modified International Index of Erectile Dysfunction score

    Time frame: baseline and up to 1 month post-baseline

    score 0 to 30 with higher score meaning better erectile function

Study contacts

Contact information is provided by the study sponsor or research team.

Satvir Basran

CONTACT

[email protected]

650-723-0948

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 11, 2022
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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