Penile Nerve Stimulation for Treatment of Delayed Ejaculation

Transcutaneous Electrical Nerve Stimulation of Penile Nerves for Treatment of Delayed Ejaculation

The aim of this clinical trial is to test the safety and feasibility of using transcutaneous electrical nerve stimulation (TENS) of the penile nerves to reduce intra-vaginal ejaculatory latency time in men with delayed ejaculation (DE). We hypothesize that this type of stimulation, either before or during sexual activity, will reduce latency time. The primary objective of this study is to determine if TENS of the penile nerve helps men with DE subjectively reduce their ejaculatory latency time. The secondary objective is to determine whether their International Index of Erectile Function (IIEF) score improves with treatment.

Study Overview

• Status: Completed
• Conditions: Delayed Ejaculation
• Intervention / Treatment: Device: TENS penile nerve stimulation

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 years or older
• Sexually active
• Diagnosed with delayed ejaculation

Exclusion Criteria:

• Less than 18 years old
• Any condition effecting the participant that would make them unable to operate the interventional device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: TENS penile nerve stimulation group; 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).

Device: TENS penile nerve stimulation; The electrode pads of the transcutaneous electrical nerve stimulation (TENS 7000) will be placed at the base of the penis (and perineum) to stimulate the penile nerves.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Index of Erectile Function (IIEF) Scale Score	Participants were surveyed before testing the device and then at the conclusion of the trial using the International Index of Erectile Function (IIEF) which is a validated multidimensional scale for erectile function and ejaculatory function in men. The questionnaire consists of 3 questions with a scale for each from 0-5 (highest overall score 15, lowest score 0). The higher the score, the better the outcome and vice versa.	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Count of Participants With Treatment-related Adverse Events as Assessed by Survey	Participants were asked about treatment related adverse events via Qualtrics survey at the conclusion of the study.	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Michael Eisenberg, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Ejaculatory Dysfunction
• Other Study ID Numbers: 52213

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data and study protocol set will be available upon request from the authors.
• IPD Sharing Time Frame: Data will be made available after publication of the study results for at least 3 years.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No