Trial Outcomes & Findings for Penile Nerve Stimulation for Treatment of Delayed Ejaculation (NCT NCT04115540)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2025-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	TENS Penile Nerve Stimulation Group Electrode pads of the transcutaneous electrical nerve stimulation (TENS 7000) placed on the penis to stimulate the penile nerves.
Overall Study STARTED	20
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Penile Nerve Stimulation for Treatment of Delayed Ejaculation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TENS Penile Nerve Stimulation Group n=14 Participants Electrode pads of the transcutaneous electrical nerve stimulation (TENS 7000) placed on the penis to stimulate the penile nerves.
Age, Continuous	64.5 years STANDARD_DEVIATION 12.96 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race/Ethnicity, Customized White	12 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Region of Enrollment United States	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Participants with data at baseline and week 12.

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.

Outcome measures

Outcome measures
Measure	TENS Penile Nerve Stimulation Group n=6 Participants Electrode pads of the transcutaneous electrical nerve stimulation (TENS 7000) placed on the penis to stimulate the penile nerves.
International Index of Erectile Function (IIEF) Scale Score Week 12	9.7 score on a scale Standard Deviation 2.2
International Index of Erectile Function (IIEF) Scale Score Baseline	7.5 score on a scale Standard Deviation 4.6

SECONDARY outcome

Timeframe: Up to 12 weeks

Participants were asked about treatment related adverse events via Qualtrics survey at the conclusion of the study.

Outcome measures

Outcome measures
Measure	TENS Penile Nerve Stimulation Group n=14 Participants Electrode pads of the transcutaneous electrical nerve stimulation (TENS 7000) placed on the penis to stimulate the penile nerves.
Count of Participants With Treatment-related Adverse Events as Assessed by Survey	0 Participants

POST_HOC outcome

Timeframe: Baseline and 12 weeks

Population: Participants with data at baseline and week 12.

The questionnaire consists of 2 questions with a scale for each from 0-5 (highest overall score 10, lowest score 0). The higher the score, the better the satisfaction and vice versa.

Outcome measures

Outcome measures
Measure	TENS Penile Nerve Stimulation Group n=6 Participants Electrode pads of the transcutaneous electrical nerve stimulation (TENS 7000) placed on the penis to stimulate the penile nerves.
Overall Satisfaction Scale Score Baseline	6.0 score on a scale Standard Deviation 3.0
Overall Satisfaction Scale Score Week 12	7.8 score on a scale Standard Deviation 1.0

POST_HOC outcome

Timeframe: 12 weeks

Population: Participants who completed the protocol

Participants were asked yes/no questions regarding improvement in sexual activity

Outcome measures

Outcome measures
Measure	TENS Penile Nerve Stimulation Group n=6 Participants Electrode pads of the transcutaneous electrical nerve stimulation (TENS 7000) placed on the penis to stimulate the penile nerves.
Number of Participants With Symptom Improvement Improved sexual activity	4 Participants
Number of Participants With Symptom Improvement Able to ejaculate faster	3 Participants
Number of Participants With Symptom Improvement Able to ejaculate more often	2 Participants

POST_HOC outcome

Timeframe: 12 weeks

Population: Participants who reported data for the respective questions

Outcome measures

Outcome measures
Measure	TENS Penile Nerve Stimulation Group n=14 Participants Electrode pads of the transcutaneous electrical nerve stimulation (TENS 7000) placed on the penis to stimulate the penile nerves.
Number of Participants Utilizing TENS Prior to Intercourse, During Intercourse, and Daily During sexual activity	5 Participants
Number of Participants Utilizing TENS Prior to Intercourse, During Intercourse, and Daily Before sexual activity	3 Participants
Number of Participants Utilizing TENS Prior to Intercourse, During Intercourse, and Daily Daily use	3 Participants

POST_HOC outcome

Timeframe: 12 weeks

Population: Participants who completed the protocol

Device related pain would not necessarily be considered to be an adverse event

Outcome measures

Outcome measures
Measure	TENS Penile Nerve Stimulation Group n=6 Participants Electrode pads of the transcutaneous electrical nerve stimulation (TENS 7000) placed on the penis to stimulate the penile nerves.
Number of Participants With Device-related Pain	2 Participants

Adverse Events

TENS Penile Nerve Stimulation Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Eisenberg MD

Stanford University

Phone: 650-723-3391

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place