UnknownNot Applicable

Genital Nerves Stimulation for Treatment for Erectile Dysfunction

Switzerland20 participantsStarted 2025-02-01

Plain-language summary

Objectives: To perform pilot study using unilateral transcutaneous electrical stimulation (TENS) on thegenital nerves (dorsal nerve penis and cavernous nerves) for improving of the intracorpereal pressure and full penil erection in men after exclusion neurogenic, endrogenic and earteriogenic disorders. The investigators hypothesize that this therapy will be effective at improving erectile dysfunction (ED). Material and methods: The study will comprised 20 patients with ED randomized in two groups. Two adhesive skin electrodes are placed, one at the root of the penis and near the pubic symphysis as a cathode, and a second 2-3cm lateral to the penis. Stimulation is delivered for 30 min at the maximal tolerable stimulation amplitude at 210μs pulse width and in one group with a pulse rate at 20Hz, the second group at 60Hz. The penile tumescence and rigidity observed during stimulation are recorded in both groups of patients. Erection Harness Score (EHS) and Quality of Erection Questionnaire (QEQ) are assessed at baseline, immediately after stimulation and 2 weeks after stimulation.

Who can participate

Age range

19 Years – 90 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients presenting characteristic symptoms of refractory ED Exclusion Criteria: * Patients\<18y and \>90y * Patients who have an implanted pacemaker * Vulnerable patients with co-morbid conditions should be excluded from this study. These co-morbid conditions include all pathologies of the cardiovascular system (Angina Pectoris, Infarct, Thrombose, Embolie, Hypertonia), pulmonary system (asthma, COPD, chr. Bronchitis), intestinal system (morbus Crohn, diverticulitis..) and any malignant disease. These co-morbid conditions also include neurologic diseases (i.e., stroke, multiple sclerosis, spinal cord injury), sacral dermal pathological conditions, congenital or other anatomical sacral anomalies (e.g. spina bifida, sacral agenesis, trauma sequelae), mobility deficits, medically complicated/uncontrolled diabetes, fecal motility disorders (fecal incontinence/constipation), chronic pelvic pain, history of recurrent urinary tract infections (UTIs), gross hematuria, prior pelvic/vaginal surgeries (incontinence/prolapse surgeries), pelvic cancer (bladder, colon, cervix, uterus, prostate), deeply infiltrating endometriosis of the pelvic plexus, sacral plexus or of the bladder, Reiter´s syndrome, and pelvic radiation. * Patients suffering from other CNS disorders (mental disorders, severe psychological problems, cerebrovascular accident less than 6 months ago). * Allergies again skin adhesive electrodes * Patients with genital lesions/surgeries, pu…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Transcutaneous electrical stimulation of the Genital Nerves for treatment ED

Timeframe: 6 months

Trial details

NCT IDNCT05231083

SponsorProf. Dr. med. Marc Possover

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-01

Contact for this trial

Marc Possover, PhD

+41797507995 m.possover@possover.com

View on ClinicalTrials.gov More Erectile Dysfunction trials