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Completed

NCT Number: NCT04115540

Penile Nerve Stimulation 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.

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Key information

Conditions

Delayed Ejaculation Ejaculatory Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Sexual Dysfunction, Physiological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Healthcare

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. International Index of Erectile Function (IIEF) Scale Score

    Time frame: Baseline and 12 weeks

    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.

Secondary outcomes

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

    Time frame: Up to 12 weeks

    Participants were asked about treatment related adverse events via Qualtrics survey at the conclusion of the study.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 4, 2019
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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