Back to resultsDouble-S: a Wearable Device for Erectile Dysfunction
Primary Purpose
Erectile Dysfunction
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Double-S
Sponsored by
About this trial
This is an interventional other trial for Erectile Dysfunction
Eligibility 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
Sites / Locations
- Stanford Healthcare, Stanford Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Double-S arm
Arm Description
Participants will be asked to use the wearable penile device during intercourse.
Outcomes
Primary Outcome Measures
Change in modified International Index of Erectile Dysfunction score
score 0 to 30 with higher score meaning better erectile function
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05451563
Brief Title
Double-S: a Wearable Device for Erectile Dysfunction
Official Title
Double-S: a Wearable Device for Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Double-S arm
Arm Type
Experimental
Arm Description
Participants will be asked to use the wearable penile device during intercourse.
Intervention Type
Device
Intervention Name(s)
Double-S
Intervention Description
Wearable device for intercourse
Primary Outcome Measure Information:
Title
Change in modified International Index of Erectile Dysfunction score
Description
score 0 to 30 with higher score meaning better erectile function
Time Frame
baseline and up to 1 month post-baseline
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Satvir Basran
Phone
650-723-0948
Email
sbasran@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Eisenberg, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Healthcare, Stanford Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Double-S: a Wearable Device for Erectile Dysfunction
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