Penile Nerve Stimulation for Treatment of Delayed Ejaculation

Stanford University

Status: Completed

Conditions: Delayed Ejaculation

Treatments: Device: TENS penile nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04115540

52213

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

TENS penile nerve stimulation group

Experimental group

Description:

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).

Treatment:

Device: TENS penile nerve stimulation