External Device for Erectile Dysfunction (3D-Erect)

Stanford University9 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Erectile Dysfunction Impotentia Erigendi

Interventions

3D-ErectDEVICE

3D-printed erectile device for intercourse

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford Health Care, Stanford Hospital

Stanford, California, United States

RECRUITING

Outcomes

Primary Outcomes

Change in modified International Index of Erectile Dysfunction score

score 0 to 30 with higher score meaning overall better erectile function

Time frame: baseline and up to 1 month post-baseline

Data from ClinicalTrials.gov

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