Double-S: a Wearable Device for Erectile Dysfunction
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|ClinicalTrials.gov Identifier: NCT05451563|
Recruitment Status : Not yet recruiting
First Posted : July 11, 2022
Last Update Posted : October 28, 2022
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction||Device: Double-S||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Double-S arm
Participants will be asked to use the wearable penile device during intercourse.
Wearable device for intercourse
- 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
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
|Contact: Satvir Basranemail@example.com|
|United States, California|
|Stanford Healthcare, Stanford Hospital|
|Stanford, California, United States, 94304|
|Principal Investigator:||Michael Eisenberg, MD||Stanford University|