Penile Nerve Stimulation for Treatment of Delayed Ejaculation

Delayed Ejaculation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04115540
• Other study ID #: 52213
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: January 31, 2024

Study information

• Verified date: March 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delayed Ejaculation
• Ejaculatory Dysfunction

Intervention

Device:
• 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) to stimulate the penile nerves.

Locations

Country	Name	City	State
United States	Stanford Healthcare	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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