Double-S: a Wearable Device for Erectile Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Double-S.
- Who it may be relevant to
- Registry conditions: Erectile Dysfunction. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Device Double-S
Wearable device for intercourse
Primary outcome measures
- Change in modified International Index of Erectile Dysfunction score [Time frame: baseline and up to 1 month post-baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Stanford Healthcare, Stanford Hospital — Stanford
Identifiers
NCT: NCT05451563 · 65457