Penile Nerve Stimulation for Treatment of Delayed Ejaculation

NCT04115540 | Completed Results FDA Device

• 1 other identifier: 52213
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delayed Ejaculation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Count of Participants With Treatment-related Adverse Events as Assessed by Survey

  Up to 12 weeks

Study Arms (1)

TENS penile nerve stimulation group

EXPERIMENTAL

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

Interventions

TENS penile nerve stimulation DEVICE

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.

TENS penile nerve stimulation group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Healthcare

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Ejaculatory Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases

Results Point of Contact

• Title: Michael Eisenberg MD
• Organization: Stanford University

meisenb@stanford.edu

650-723-3391

Study Officials

• Michael Eisenberg, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 4, 2019
• Study Start: January 10, 2019
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: March 20, 2025
• Results First Posted: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available after publication of the study results for at least 3 years.

Locations

US (1)