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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Stanford Healthcare
Stanford, California, United States
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
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
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