Double-S: a Wearable Device for Erectile Dysfunction

Not Applicable

Recruiting

• Conditions: Erectile Dysfunction
• Interventions: Device: Double-S

• Registration Number: NCT05451563
• Lead Sponsor: Stanford University

Brief Summary

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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-07-06
• Study First Submitted QC: 2022-07-06
• Study First Posted: 2022-07-11
• Status Verified: 2024-03
• Study Start: 2024-03-21
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-27
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 10

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

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Exclusion Criteria

• not willing to attempt sexual vaginal intercourse with their partner
• inability to wear/operate the external penile device for any reason

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Double-S arm	Double-S	Participants will be asked to use the wearable penile device during intercourse.

Primary Outcome Measures

Name	Time	Method
Change in modified International Index of Erectile Dysfunction score	baseline and up to 1 month post-baseline	score 0 to 30 with higher score meaning better erectile function

Trial Locations

Locations (1)

Stanford Healthcare, Stanford Hospital; 🇺🇸 Stanford, California, United States