Wearable Device for Erectile Dysfunction

Overseen By Satvir Basran

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Not willing to attempt intercourse, inability to use device

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial uses a small device to help men with erectile dysfunction achieve an erection. It targets men who haven't responded to typical treatments or have erectile issues due to surgery or other health problems. The device works by providing mechanical support to keep the penis firm for sex.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Double-S, Double-S for erectile dysfunction?

The research on external vacuum devices shows that they can help 87% of men achieve erections suitable for intercourse, and improve sexual satisfaction for both men and their partners. This suggests that similar treatments, like the wearable device in the trial, might also be effective. ^{1 2 3 4 5}

Who Is on the Research Team?

Michael Eisenberg, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for men over 18 with moderate to severe erectile dysfunction from various causes, such as post-prostate surgery or psychological issues. They must have a female partner willing to participate and be open to trying sexual intercourse.

Inclusion Criteria

My female partner is willing to join the study with me.

I have erectile dysfunction due to prostate cancer treatment or other health issues.

Exclusion Criteria

I am not willing to have sexual intercourse.

Inability to wear/operate the external penile device for any reason

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the wearable penile device during intercourse

4 weeks

Follow-up

Participants are monitored for changes in erectile function using the International Index of Erectile Dysfunction score

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Double-S

Trial Overview The study is testing 'Double-S', a wearable device designed as a minimally invasive solution for those experiencing erectile dysfunction, aiming to improve their condition.

How Is the Trial Designed?

Group I: Double-S arm Experimental Treatment 1 Intervention

Participants will be asked to use the wearable penile device during intercourse.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Over 96% of male patients with erectile dysfunction reported being able to maintain an erection using the vacuum constriction device, and all participants indicated they would recommend it to others, highlighting its efficacy and user satisfaction.

Female partners of the patients also reported improved sexual experiences, with 83.8% rating sex as better when using the device, indicating a positive impact on intimacy and relationship satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction with a Vacuum Constriction Device for Erectile Dysfunction among Middle-Aged and Older Veterans. Beaudreau, SA., Van Moorleghem, K., Dodd, SM., et al.[2021]

The Erectile Function Pineda Visual Analog Scale was developed and tested on 227 men with erectile dysfunction, showing significant advantages in understanding and response time compared to the International Index of Erectile Function, especially among patients with lower educational levels.

This new visual scale can serve as an effective alternative diagnostic tool for erectile dysfunction, particularly for individuals with academic and linguistic limitations, providing a more accessible option for assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The Erectile Function Pineda Visual Analog Scale (EFP-VAS): An alternative to the International Index of Erectile Function (IIEF-5)]. Pineda-Murillo, J., Martínez-Carrillo, G., Hernández-León, O., et al.[2021]

In a 12-month study, an external vacuum device successfully produced erections sufficient for intercourse in 87% of men with erectile dysfunction, indicating its high efficacy as a treatment option.

The use of the device not only improved sexual functioning for men and their partners but also led to a reduction in psychiatric symptoms for the men, highlighting its positive psychosocial effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External vacuum devices in the treatment of erectile dysfunction: a one-year study of sexual and psychosocial impact. Turner, LA., Althof, SE., Levine, SB., et al.[2007]

In a study of 74 patients followed for an average of nearly 9 years, the inflatable penile prosthesis demonstrated high long-term survival rates, with mechanical survival at 93.3% at 5 years and 64.8% at 15 years.

Patient satisfaction was notably high, with 86.8% of participants expressing satisfaction with the device, and 83.0% indicating they would choose the procedure again, although only 60.4% reported achieving orgasm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term survival and patient satisfaction with inflatable penile prosthesis for the treatment of erectile dysfunction. Ji, YS., Ko, YH., Song, PH., et al.[2018]

The three-piece inflatable penile prosthesis showed a high effectiveness rate of 97.9% in treating erectile dysfunction (ED) across 48 cases, with nearly 100% patient satisfaction reported post-surgery.

The procedure demonstrated a good safety profile, with no major complications like rejection or mechanical failure, although there were minor issues such as post-operative infections in 4.17% of cases and some penile pain in 16.67%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Three-piece inflatable penile prosthesis implantation for the treatment of penile erectile dysfunction]. Deng, ZN., Chen, ZG., Feng, YP.[2007]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Satisfaction with a Vacuum Constriction Device for Erectile Dysfunction among Middle-Aged and Older Veterans. [2021]

2. Spain pubmed.ncbi.nlm.nih.gov

[The Erectile Function Pineda Visual Analog Scale (EFP-VAS): An alternative to the International Index of Erectile Function (IIEF-5)]. [2021]

3. England pubmed.ncbi.nlm.nih.gov

External vacuum devices in the treatment of erectile dysfunction: a one-year study of sexual and psychosocial impact. [2007]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Long-term survival and patient satisfaction with inflatable penile prosthesis for the treatment of erectile dysfunction. [2018]

5. China pubmed.ncbi.nlm.nih.gov

[Three-piece inflatable penile prosthesis implantation for the treatment of penile erectile dysfunction]. [2007]