Penile Nerve Stimulation for Delayed Ejaculation

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Stanford University

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

Compensation: Varies

Number of Visits: Unknown

Duration: 18 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a device that sends mild electrical pulses to the nerves in the penis to help men who have trouble ejaculating quickly enough. The goal is to see if this treatment can make ejaculation happen faster and improve overall sexual function.

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 data supports the effectiveness of the treatment TENS penile nerve stimulation for delayed ejaculation?

Research on similar treatments, like transcutaneous electrical stimulation (TES) for premature ejaculation, shows promising results, with significant increases in ejaculation time. This suggests that nerve stimulation therapies can be effective in addressing ejaculation issues. ^{1 2 3 4 5}

Is penile nerve stimulation safe for humans?

Research on similar nerve stimulation treatments, like transcutaneous posterior tibial nerve stimulation and transcutaneous electrical stimulation, shows they are generally safe with no serious side effects reported. Some minor effects like constipation and a sensation of heat were noted, but larger studies are needed to confirm safety. ^{1 3 6 7 8}

How does TENS penile nerve stimulation treatment for delayed ejaculation differ from other treatments?

TENS penile nerve stimulation is unique because it uses electrical impulses to stimulate nerves, which is different from traditional treatments that might involve medications or behavioral therapy. This method is non-invasive and can be adjusted based on individual sensitivity, offering a personalized approach to managing delayed ejaculation. ^{1 2 3 8 9}

Research Team

Michael Eisenberg, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for sexually active men aged 18 or older who have been diagnosed with delayed ejaculation. Participants must be capable of operating the device used in the study.

Inclusion Criteria

I have been diagnosed with delayed ejaculation.

I am sexually active.

I am 18 years old or older.

Exclusion Criteria

Any condition effecting the participant that would make them unable to operate the interventional device

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use TENS device for penile nerve stimulation in three different ways for 6 weeks each

18 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• TENS penile nerve stimulation

Trial Overview The study tests if TENS, a method that uses electrical stimulation on penile nerves, can help reduce the time it takes for men with delayed ejaculation to reach climax during sexual activity.

Participant Groups

Group I: TENS penile nerve stimulation group Experimental Treatment 1 Intervention

The electrode pads of the transcutaneous electrical nerve stimulation (TENS 7000) will be placed at the base of the penis (and perineum). Participants will be able to use the device prior to sexual activity (immediately before sexual encounter for 10 minutes or daily for up to 14 days prior) to "prime" their system or during sexual activity. Each participant will use the device these three separate ways for 6 weeks each (total of 18 weeks of use).

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electric nerve stimulation to treat patients with premature ejaculation: phase II clinical trial. [2021]

2. China pubmed.ncbi.nlm.nih.gov

[Treatment and mechanism study of electromagnetic stimulation and vibrational massage for patients with ejaculatory incompetence]. [2004]

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

Transcutaneous functional electrical stimulation-a novel therapy for premature ejaculation: results of a proof of concept study. [2021]

4. China pubmed.ncbi.nlm.nih.gov

Psychosexual therapy for delayed ejaculation based on the Sexual Tipping Point model. [2023]

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

The pathophysiology of delayed ejaculation. [2020]

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

The safety and efficacy of dorsal penile nerve block for premature ejaculation: A systematic review and meta-analysis. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The Men's Training Cup Keep Training: a masturbation aid improves intravaginal ejaculatory latency time and Erection Hardness Score in patients who are unable to delay ejaculation. [2023]

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

Transcutaneous Electrical Nerve Stimulation to Improve Female Sexual Dysfunction Symptoms: A Pilot Study. [2022]

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

Efficacy of Sphincter Control Training and medical device in the treatment of premature ejaculation: A multicenter randomized controlled clinical trial. [2021]