Penile Nerve Stimulation for Treatment of Delayed Ejaculation

Study Overview
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Brief Summary
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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.

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

Conditions
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Delayed Ejaculation

Intervention / Treatment
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* Device: TENS penile nerve stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TENS penile nerve stimulation group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in scores on International Index of Erectile Function | Participants will be surveyed before testing the device and then at the conclusion of the trial to assess for mean changes in International Index of Erectile Function which is a validated multidimensional scale for erectile function and ejaculatory function in men. The questionnaire consists of 15 questions with a scale for each from 0-5 (highest score 75, lowest score 0). The higher the score, the better the outcome and vice versa. | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Count of participants with treatment-related adverse events as assessed by survey | Participants will be asked about treatment related adverse events via Qualtrics survey at the conclusion of the study. Additionally, participants will be contacted every 2 weeks for check in at which time they will also be asked. | 18 weeks |