Erectile Dysfunction, Impotentia Erigendi
Conditions
Brief summary
The aim of this clinical trial is to test the safety and feasibility of a non-invasive 3D-printed external penile device to achieve successful and satisfactory sexual intercourse in men with erectile dysfunction (ED).
Detailed description
A clinical trial to test the safety and feasibility of our newly developed non-invasive 3D-printed external penile device for the treatment and recovery of erectile dysfunction.
Interventions
DEVICE3D-Erect
3D-printed erectile device for intercourse
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
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 overall better erectile function |
Countries
United States
Outcome results
None listed