What side effects are associated with this type of intervention?

Common side effects of treatments for delayed ejaculation that involve electrical nerve stimulation, such as Transcutaneous Electrical Nerve Stimulation (TENS), include mild discomfort or pain at the site of stimulation, skin irritation, muscle twitching, temporary changes in sensation, and mild fatigue. Patients should discuss these potential side effects with their healthcare provider to ensure the benefits outweigh any risks.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for Delayed Ejaculation involving Transcutaneous Electrical Nerve Stimulation (TENS) in the provided context. However, TENS is being studied for its potential to reduce ejaculatory latency time by modulating nerve activity through electrical impulses. Broadly, treatments for Delayed Ejaculation may include pharmacologic agents, behavioral therapies, and other neuromodulation techniques, but specific FDA approvals for TENS in this context are not detailed.

What other types of research exist?

Promising novel alternatives to TENS for delayed ejaculation include penile nerve stimulation and spinal cord stimulation. These methods involve targeted electrical stimulation to modulate nerve activity and have shown potential in clinical trials. Additionally, cognitive behavioral therapy and pharmacological treatments like PDE-5 inhibitors may also be considered as complementary approaches.

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Behavioral Intervention

Penile Nerve Stimulation for Delayed Ejaculation

N/A

Waitlist Available

Led By Michael Eisenberg, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with delayed ejaculation

18 years or older

Must not have

Less than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the site of stimulation, skin irritation from electrode pads, and possible temporary changes in sexual function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with delayed ejaculation.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean change from baseline in scores on International Index of Erectile Function

Secondary study objectives

Count of participants with treatment-related adverse events as assessed by survey

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TENS penile nerve stimulation groupExperimental Treatment1 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TENS penile nerve stimulation

2019

N/A

~20

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Transcutaneous Electrical Nerve Stimulation (TENS) for Delayed Ejaculation (DE) involves applying electrical impulses to the penile nerves to modulate nerve activity. This method aims to enhance nerve signaling and improve the coordination of muscular contractions necessary for ejaculation. For DE patients, this non-invasive treatment directly targets the neural pathways involved in ejaculation, offering a potential solution without the need for systemic medications or invasive procedures.