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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TENS penile nerve stimulation group | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENS penile nerve stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| International Index of Erectile Function (IIEF) Scale Score | 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. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Participants With Treatment-related Adverse Events as Assessed by Survey | Participants were asked about treatment related adverse events via Qualtrics survey at the conclusion of the study. | Up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Eisenberg, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Healthcare | Stanford | California | 94305 | United States |
De-identified data and study protocol set will be available upon request from the authors.
Data will be made available after publication of the study results for at least 3 years.
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| ID | Title | Description |
|---|---|---|
| FG000 | TENS Penile Nerve Stimulation Group | Electrode pads of the transcutaneous electrical nerve stimulation (TENS 7000) placed on the penis to stimulate the penile nerves. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | TENS Penile Nerve Stimulation Group | Electrode pads of the transcutaneous electrical nerve stimulation (TENS 7000) placed on the penis to stimulate the penile nerves. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | International Index of Erectile Function (IIEF) Scale Score | 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. | Participants with data at baseline and week 12. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
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12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TENS Penile Nerve Stimulation Group | Electrode pads of the transcutaneous electrical nerve stimulation (TENS 7000) placed on the penis to stimulate the penile nerves. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Eisenberg MD | Stanford University | 650-723-3391 | meisenb@stanford.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 19, 2021 | Mar 14, 2025 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D000097910 | Ejaculatory Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Count of Participants With Treatment-related Adverse Events as Assessed by Survey | Participants were asked about treatment related adverse events via Qualtrics survey at the conclusion of the study. | Posted | Count of Participants | Participants | Up to 12 weeks |
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| Post-Hoc | Overall Satisfaction Scale Score | 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. | Participants with data at baseline and week 12. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
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| Post-Hoc | Number of Participants With Symptom Improvement | Participants were asked yes/no questions regarding improvement in sexual activity | Participants who completed the protocol | Posted | Count of Participants | Participants | 12 weeks |
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| Post-Hoc | Number of Participants Utilizing TENS Prior to Intercourse, During Intercourse, and Daily | Participants who reported data for the respective questions | Posted | Count of Participants | Participants | 12 weeks |
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| Post-Hoc | Number of Participants With Device-related Pain | Device related pain would not necessarily be considered to be an adverse event | Participants who completed the protocol | Posted | Count of Participants | Participants | 12 weeks |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
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| D052801 | Male Urogenital Diseases |
| Title |
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| Measurements |
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| Title | Measurements |
|---|---|
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| Daily use |
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