Double-S: a Wearable Device for Erectile Dysfunction

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05451563

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Device: Double-S	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Double-S: a Wearable Device for Erectile Dysfunction

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Double-S arm Participants will be asked to use the wearable penile device during intercourse.	Device: Double-S Wearable device for intercourse

Arm

Intervention/Treatment

Experimental: Double-S arm

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

Device: Double-S

Wearable device for intercourse

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Healthcare, Stanford Hospital	Stanford	California	United States	94304

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator: Michael Eisenberg, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Eisenberg, Michael Eisenberg M.D., Stanford University

ClinicalTrials.gov Identifier:

NCT05451563

Other Study ID Numbers:

65457

First Posted:

Jul 11, 2022

Last Update Posted:

Jul 11, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Erectile Dysfunction

Study Results

No Results Posted as of Jul 11, 2022