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Double-S: a Wearable Device for Erectile Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05451563
Recruitment Status : Not yet recruiting
First Posted : July 11, 2022
Last Update Posted : October 28, 2022
Sponsor:
Information provided by (Responsible Party):
Michael Eisenberg, Stanford University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : December 15, 2022
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05451563


Contacts
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Contact: Satvir Basran 650-723-0948 sbasran@stanford.edu

Locations
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United States, California
Stanford Healthcare, Stanford Hospital
Stanford, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Michael Eisenberg, MD Stanford University
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Responsible Party: Michael Eisenberg, Michael Eisenberg M.D., Stanford University
ClinicalTrials.gov Identifier: NCT05451563    
Other Study ID Numbers: 65457
First Posted: July 11, 2022    Key Record Dates
Last Update Posted: October 28, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders