Double-S: a Wearable Device for Erectile Dysfunction

Stanford University

Status: Enrolling

Conditions: Erectile Dysfunction

Treatments: Device: Double-S

Study type: Interventional

Funder types: Other

Identifiers

NCT05451563

65457

Details and patient eligibility

About

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

Full description

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.

Enrollment: 10 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Double-S arm

Experimental group

Description:

Participants will be asked to use the wearable penile device during intercourse.

Treatment:

Device: Double-S