External Device for Erectile Dysfunction

(3D-Erect Trial)

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Stanford University

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

9 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new, non-invasive 3D-printed device called 3D-Erect, designed to help men with erectile dysfunction (ED) achieve satisfying sexual intercourse. Researchers aim to determine if this device is safe and practical. Men with moderate to severe ED, possibly due to treatments for prostate cancer or other conditions, and who have a female partner willing to join the study, might be suitable candidates. Participants will use the device during intercourse with their partner to test its effectiveness.

As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could enhance quality of life for many.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that the 3D-Erect device is designed to assist men with erectile dysfunction without surgery or medication. This trial aims to ensure the device is safe and easy to use. Although detailed safety information about the 3D-Erect is not yet available, the trial is in a phase that focuses on testing devices or procedures, not drugs.

The FDA has already approved other devices for erectile dysfunction, such as the Viberect, indicating that similar devices are generally safe. However, the results of this trial are necessary to learn more about the 3D-Erect's safety. It is important to consult a doctor before joining any trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard medications and devices for erectile dysfunction, which often involve oral pills like Viagra or injections, the 3D-Erect is a new approach using 3D printing technology to create a custom-fit, external device. This unique delivery method offers a non-invasive alternative that could be easier and more comfortable for users. Researchers are excited about the potential for personalized solutions that this technology brings, as it could provide a more tailored experience with fewer side effects compared to traditional treatments.

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

Research shows that the 3D-Erect device, used by participants in this trial, is designed to help men with erectile dysfunction (ED) achieve satisfying sexual intercourse. This non-invasive device, made with 3D printing technology, provides mechanical support to maintain an erection. Studies have found that external devices can be effective for men who do not respond well to medication. The 3D-Erect device offers structural support, which can be particularly beneficial for those with moderate to severe ED, especially after surgeries like prostate removal. Although limited data exists specifically on the 3D-Erect, similar devices have improved sexual function and satisfaction. ^{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 cancer treatment or vascular issues. Participants must have a female partner willing to be involved and must be open to trying sexual intercourse using the device.

Inclusion Criteria

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

Exclusion Criteria

I am not willing to have sexual vaginal intercourse.

You cannot use 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 3D-printed penile device during intercourse

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 3D-Erect

Trial Overview The study is evaluating the safety and effectiveness of a non-invasive, 3D-printed external penile device designed to help men with erectile dysfunction achieve satisfactory sexual intercourse.

How Is the Trial Designed?

Group I: 3D-Erect arm Experimental Treatment 1 Intervention

Participants will be asked to use the 3D-printed penile device during their intercourse with partners.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

The Viberect device, which uses vibratory stimulation to activate genital nerves, was shown to effectively induce erections in 4 out of 5 healthy men, demonstrating its potential as a non-invasive treatment for erectile dysfunction.

All participants reported that Viberect was a practical option for treating erectile dysfunction, and there were no reported complications, indicating its safety and tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Viberect penile vibratory stimulation system: evaluation of its erectogenic efficacy. Segal, RL., Tajkarimi, K., Burnett, AL.[2019]

The new programmable electronic vacuum erection devices, specifically the Vacuum Plus Tratamiento (VPT), have shown efficacy in treating and preventing erectile dysfunction caused by early fibrosis in the penile vascular system, as demonstrated in a study of 20 patients.

These devices work by using low negative pressures to dilate the arterial vascular system of the corpus cavernosum, leading to satisfactory results in achieving passive erections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A new vacuum mechanism for the etiologic treatment of erectile dysfunction]. Rosselló Barbará, M.[2006]

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]

In a study of 29 men using external vacuum devices for 6 months, there were significant improvements in erectile quality, sexual satisfaction, and overall psychosocial well-being, indicating the device's effectiveness in treating erectile dysfunction.

The vacuum device successfully produced erections in 89% of participants, demonstrating its safety and high acceptance among users, with only a 19% dropout rate mainly due to minor side effects like bruising.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating erectile dysfunction with external vacuum devices: impact upon sexual, psychological and marital functioning. Turner, LA., Althof, SE., Levine, SB., et al.[2019]

External erection devices, such as vacuum constriction devices, have become increasingly popular as a noninvasive and drug-free option for managing erectile dysfunction, especially as societal stigma decreases.

These devices are effective in providing erections and have been associated with high patient satisfaction, making them a valuable alternative for individuals who may not respond to or prefer not to use medications like sildenafil citrate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vacuum constriction and external erection devices in erectile dysfunction. Levine, LA., Dimitriou, RJ.[2019]

In a clinical trial involving 61 impotent men, the external vacuum erection device demonstrated an overall effectiveness rate of 67%, with 88% of patients with arteriogenic impotence reporting satisfactory results and improved spontaneous erections.

The device was generally well-received, with over 80% of users rating their satisfaction with erection quality and ability to perform intercourse above 5 on a scale of 1 to 10, although some adverse effects like blocked ejaculation and bruising were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating erectile dysfunction with a vacuum tumescence device: a retrospective analysis of acceptance and satisfaction. Baltaci, S., Aydos, K., Kosar, A., et al.[2019]

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]

Mirodenafil significantly improved erectile function compared to placebo, with a notable increase in the International Index of Erectile Function (IIEF) erectile function domain score after 12 weeks of treatment in a meta-analysis of 374 participants from three randomized controlled trials.

The treatment was well-tolerated, with common side effects including flushing and headache, but these were relatively mild compared to the benefits observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of mirodenafil for patients with erectile dysfunction: a meta-analysis of three multicenter, randomized, double-blind, placebo-controlled clinical trials. Du, W., Li, J., Fan, N., et al.[2015]

The Osbon ErecAid Vacuum Therapy System significantly improved erectile function in 70 patients aged 25-66 who did not respond to PDE-5 inhibitors, with IIEF-5 scores increasing from 10.2 to 13.3 after 3 months of treatment.

The therapy demonstrated a 77.1% effectiveness rate, with over 64% of both patients and their partners reporting increased sexual satisfaction, indicating its potential as a viable treatment option for erectile dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Vacuum therapy for erectile dysfunction that fails to respond to PDE-5i: report of 70 cases]. Li, P., Shen, YJ., Liu, TQ., et al.[2013]

In a study of 20 patients with impotence, the Correctaid external erection assistance device was found to be a useful non-invasive treatment option, particularly for motivated individuals and their partners.

After 14 months of follow-up, only 4 patients continued to use the device regularly for satisfactory intercourse, while another 4 used it occasionally, indicating variable long-term adherence and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the "Correctaid" device in the management of impotence. Asopa, R., Williams, G.[2019]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04624126?tab=results

External Device for Erectile Dysfunction (3D-Erect) A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3891291/

New advances in erectile technology - PMC - PubMed Central The role of technology in the treatment of erectile dysfunction (ED) will be widened and more options will be available in the years to come. These erectile ...

3. trialx.com trialx.com/clinical-trials/listings/228955/external-device-for-erectile-dysfunction-3d-erect/

External Device for Erectile Dysfunction (3D-Erect) Inclusion Criteria: males >18 years old suffering from any cause moderate to severe erectile dysfunction (e.g. ED after radical prostatectomy ...

4. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/e/NCT04624126.html

External Device for Erectile Dysfunction (3D-Erect) Inclusion Criteria: * males \>18 years old suffering from any cause moderate to severe erectile dysfunction (e.g. ED after radical prostatectomy and/or ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2405456924000841

App-based Therapy of Erectile Dysfunction Using a Digital ... Erectile dysfunction (ED) is common among males. According to the ... [First data from a digital health app for erectile dysfunction]. Urologie, 61 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05650866

Study Details | NCT05650866 | Safety and Tolerability of a ... The goal of this clinical trial is to assess if a new device is safe to use as a potential treatment for erectile dysfunction following radical prostatectomy.