Penile Nerve Stimulation for Treatment of Delayed Ejaculation

Not Applicable

Completed

• Conditions: Delayed Ejaculation
• Interventions: Device: TENS penile nerve stimulation

• Registration Number: NCT04115540
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-10
• Study First Submitted: 2019-09-30
• Study First Submitted QC: 2019-10-01
• Study First Posted: 2019-10-04
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TENS penile nerve stimulation group	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). 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).

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in scores on International Index of Erectile Function	18 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Count of participants with treatment-related adverse events as assessed by survey	18 weeks	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.

Trial Locations

Locations (1)

Stanford Healthcare; 🇺🇸 Stanford, California, United States