Delayed Ejaculation
Conditions
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.
Interventions
DEVICETENS 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.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Index of Erectile Function (IIEF) Scale Score | Baseline and 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants With Treatment-related Adverse Events as Assessed by Survey | Up to 12 weeks | Participants were asked about treatment related adverse events via Qualtrics survey at the conclusion of the study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TENS Penile Nerve Stimulation Group Electrode pads of the transcutaneous electrical nerve stimulation (TENS 7000) placed on the penis to stimulate the penile nerves. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | TENS Penile Nerve Stimulation Group |
|---|---|
| Age, Continuous | 64.5 years STANDARD_DEVIATION 12.96 |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 12 Participants |
| Region of Enrollment United States | 14 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
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.
Time frame: Baseline and 12 weeks
Population: Participants with data at baseline and week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TENS Penile Nerve Stimulation Group | International Index of Erectile Function (IIEF) Scale Score | Baseline | 7.5 score on a scale | Standard Deviation 4.6 |
| TENS Penile Nerve Stimulation Group | International Index of Erectile Function (IIEF) Scale Score | Week 12 | 9.7 score on a scale | Standard Deviation 2.2 |
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.
Time frame: Up to 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TENS Penile Nerve Stimulation Group | Count of Participants With Treatment-related Adverse Events as Assessed by Survey | 0 Participants |
Post Hoc
Number of Participants Utilizing TENS Prior to Intercourse, During Intercourse, and Daily
Time frame: 12 weeks
Population: Participants who reported data for the respective questions
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TENS Penile Nerve Stimulation Group | Number of Participants Utilizing TENS Prior to Intercourse, During Intercourse, and Daily | During sexual activity | 5 Participants |
| TENS Penile Nerve Stimulation Group | Number of Participants Utilizing TENS Prior to Intercourse, During Intercourse, and Daily | Before sexual activity | 3 Participants |
| TENS Penile Nerve Stimulation Group | Number of Participants Utilizing TENS Prior to Intercourse, During Intercourse, and Daily | Daily use | 3 Participants |
Post Hoc
Number of Participants With Device-related Pain
Device related pain would not necessarily be considered to be an adverse event
Time frame: 12 weeks
Population: Participants who completed the protocol
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TENS Penile Nerve Stimulation Group | Number of Participants With Device-related Pain | 2 Participants |
Post Hoc
Number of Participants With Symptom Improvement
Participants were asked yes/no questions regarding improvement in sexual activity
Time frame: 12 weeks
Population: Participants who completed the protocol
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TENS Penile Nerve Stimulation Group | Number of Participants With Symptom Improvement | Improved sexual activity | 4 Participants |
| TENS Penile Nerve Stimulation Group | Number of Participants With Symptom Improvement | Able to ejaculate faster | 3 Participants |
| TENS Penile Nerve Stimulation Group | Number of Participants With Symptom Improvement | Able to ejaculate more often | 2 Participants |
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.
Time frame: Baseline and 12 weeks
Population: Participants with data at baseline and week 12.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TENS Penile Nerve Stimulation Group | Overall Satisfaction Scale Score | Baseline | 6.0 score on a scale | Standard Deviation 3 |
| TENS Penile Nerve Stimulation Group | Overall Satisfaction Scale Score | Week 12 | 7.8 score on a scale | Standard Deviation 1 |