Erectile Dysfunction
Conditions
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.
Interventions
DEVICEDouble-S
Wearable device for intercourse
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactSatvir Basran
Outcome results
None listed