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

Stanford University1 site in 1 country20 target enrollmentJanuary 10, 2019

ConditionsDelayed Ejaculation

Overview

Phase: N/A
Intervention: Not specified
Conditions: Delayed Ejaculation
Sponsor: Stanford University
Enrollment: 20
Locations: 1
Primary Endpoint: International Index of Erectile Function (IIEF) Scale Score
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 10, 2019

End Date

January 31, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Stanford University

Responsible Party

Principal Investigator

Michael Eisenberg

Associate Professor of Urology

Stanford University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.