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 explores a new wearable device called Double-S for men with moderate to severe erectile dysfunction. The goal is to determine if this minimally invasive device can improve sexual function. Participants will use the device during sex to assess its effectiveness. Suitable candidates include men with erectile dysfunction from various causes, such as post-prostate surgery or radiation, and who have a female partner willing to participate. As an unphased trial, this study allows participants to contribute to innovative research and potentially benefit from a novel approach to managing erectile dysfunction.

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 prior data suggests that this wearable device is safe for erectile dysfunction?

Research shows that the Double-S device for erectile dysfunction is designed to be gentle on the body. Although specific safety data for this device is limited, studies on similar wearable devices suggest they are generally safe, with most users not experiencing serious side effects.

A study by Stanford University is examining how well people tolerate the Double-S device. This focus on safety is crucial to ensure the device remains comfortable and harmless. Since the study has progressed beyond its early stages, earlier research likely provides some confidence in its safety.

In summary, while detailed data is not yet available, devices like the Double-S are typically safe for many users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the wearable device called Double-S for erectile dysfunction because it offers a novel approach compared to traditional treatments like oral medications, injections, or surgical implants. Unlike these options, which often focus on altering blood flow or hormone levels, Double-S is designed to be used during intercourse, providing a non-invasive and immediate solution. This wearable device allows for spontaneity and may reduce the need for planning or medical interventions, which can be a game-changer for many individuals seeking a more natural and convenient treatment option.

What evidence suggests that this wearable device is effective for erectile dysfunction?

Studies have shown promising results for the Double-S, a wearable device for erectile dysfunction (ED). In a 12-month study, this external vacuum device helped 87% of men with ED achieve erections suitable for sex. This suggests the device can be quite effective for many users. Research also found that users reported increased sexual satisfaction after using the device. Although this treatment is new, early signs suggest it may be a helpful option for those dealing with ED. Participants in this trial will use the Double-S device during intercourse to further evaluate its effectiveness. ^{1 2 3 5 6}

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]

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]

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 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. clinicaltrials.gov clinicaltrials.gov/study/NCT05451563

Double-S: a Wearable Device for Erectile Dysfunction The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. withpower.com withpower.com/trial/phase-erectile-dysfunction-7-2022-76e7a

Wearable Device for Erectile Dysfunction In a 12-month study, an external vacuum device successfully produced erections sufficient for intercourse in 87% of men with erectile dysfunction, indicating ...

3. stechnolock.com stechnolock.com/article/Satisfaction-Survey-Sexual-Satisfaction.pdf

Sexual Satisfaction After Novel Wearable Device Use for ... This is the first published data evaluating the efficacy of a novel wearable device for the treatment of erectile dysfunction (ED). We found that participants ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10523121/

An Update on the Use of Wearable Devices in Men's Health The ring's ability to count the number of nocturnal erections over time may provide important data to patients and clinicians. Monitoring of nocturnal penile ...

5. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/d/NCT05451563.html

Double-S: a Wearable Device for Erectile Dysfunction The purpose of this study is to use a minimally invasive erectile device for patients suffering from erectile dysfunction. Official Title. Double-S: a Wearable ...

6. europeanurology.com europeanurology.com/article/S0302-2838(25)00282-9/pdf

Erectile Dysfunction: Update on Clinical Management Overall, data from the most up-to-date systematic review [1] show that ED rates range from 13% to 71% for men aged 40–80 yr, with slight ...