Erectile DysfunctionGNSNCT05231083
Genital Nerves Stimulation for Treatment for Erectile Dysfunction
A study testing Genital Nerves Stimulation in people with Erectile Dysfunction, run by Prof. Dr. med. Marc Possover at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 90 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Genital Nerves Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting characteristic symptoms of refractory ED
Who cannot join
- 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, pudendal nerve lesion/surgery or genital surgeries, vascular disease or neurological disorders were excluded. Due to the risk of iatrogenic lesions of the erectile nerves, patients suffering from ED secondary to radical prostatectomy are not prime candidates for such a study, however due to the incidence of this etiology and the important impact in the general male population, we decided to include these patients in our study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcutaneous Electrical Stimulation of the Genital Nerves (GN) to Improve Erection Dysfunction (ED) in Men: a Pilot Study
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.
Read the detailed description
The study is a randomized prospective unblended study. 20 male patients with ED participated to the study. Vulnerable patients, patients with a pacemaker, patients with genital lesions, previous pudendal nerve or genital surgeries, vascular disease or neurological disorders are excluded. Due to the risk of iatrogenic lesions of the erectile nerves, patients suffering from ED secondary to radical prostatectomy are not prime candidates for such a study, however due to the incidence of this etiology and the important impact in the general male population, the investigators decided to include these patients in participants study. The assessment at baseline consistes of a medical history, a neuropelveological workup of the pelvic somatic nerves, pudendal ultrasonography with doppler. Stimulation is performed using a battery powered handled stimulator (N602-1C TENS Elektrostimulator - CH). Monophasic square constant current pulse with a pulse duration of 210 μs. The patients are randomized into two separate groups, a group A with fixed stimulation at 20Hz, a group B with fixed stimulation at 60Hz. Because both genital nerves are located just few millimeters below the skin, stimulation can be achieved using two adhesive skin surface electrodes (diameter 32mm, PALS Platinum, Axelgaard, Lystrup, Denmark), one placed at the root of the penis and in vicinity of the symphysis pubis as a cathode, and a second 2-3cm lateral to the penis. Precautions are taken to ensure good contact between skin and the electrodes, including removal of hairs. Furthermore, the patients are instructed to place the electrodes correctly and to clean the skin before application of the electrodes. The patients are encouraged to set the amplitude as high as tolerable each time when stimulating at home.
Because the different genital nerves may react to different frequency of stimulation , stimulation is delivered for 30 min at the maximal tolerable stimulation amplitude at 210μs pulse width with a pulse rate at 20Hz in patients group A, and at 60Hz in patients group B.
The first transcutaneous stimulation is performed in the presence of MP: The penile tumescence and rigidity observed during stimulation are recorded in both groups of patients. Then stimulation is performed at home at least twice daily for 15 min in each session for a period of 2 weeks. The patients recorde the stimulation amplitude after each session. Erection Harness Score (EHS) and Quality of Erection Questionnaire (QEQ) are assessed for 2 weeks before stimulation, during the 2 weeks of stimulation, and for 2 weeks after the final stimulation.
- Conditions
- Erectile Dysfunction
- Being tested
- Genital Nerves Stimulation
- Keywords
- erectile dysfunction, Genital Nerves Stimulation
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genital Nerves StimulationDevice
Transcutaneous electrical stimulation of the genital nerves using a TENS device and skin adhesive surface electrodes
| Study group | Role | What they receive |
|---|---|---|
| Arm A - 20Hz Stimulation | Experimental | Transcutaneous stimulation of the genital nerves at 20Hz Receives: Device: Genital Nerves Stimulation |
| Arm B - 60Hz Stimulation | Experimental | Transcutaneous stimulation of the genital nerves at 60Hz Receives: Device: Genital Nerves Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcutaneous electrical stimulation of the Genital Nerves for treatment ED
Examining the efficacy of transcutaneous genital nerve stimulation (TENS) in the treatment of ED utilizing the International Index of Erectile Function-15 score:
- Erectile function (Q1,2,3,4,5,15): Max score 30 B. Orgasmic function (Q9,19): Max score 10 C: Sexual desire (Q11,12): Max score 10 D: Intercourse satisfaction (Q6,7,8): Max score 15 E: Overall satisfaction (Q13,14): Max Score 10
IEEFscores <14 out of 39 in domain A (erectile function) may be considered for therapy and referred for specialist investigation.
Measured: 6 months
Secondary outcomes (1)
Quality of erection by using two different frequency of stimulation
The quality of erection by using the Erectile Function-15 score will be compared between two different frequency of stimulation, 20 and 60Hz with following scores:
- Erectile function (Q1,2,3,4,5,15): Max score 30 B. Orgasmic function (Q9,19): Max score 10 C: Sexual desire (Q11,12): Max score 10 D: Intercourse satisfaction (Q6,7,8): Max score 15 E: Overall satisfaction (Q13,14): Max Score 10 IEEFscores <14 out of 39 in domain A (erectile function) may be considered for therapy and referred for specialist investigation.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Feb 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocebtric randomized unblinded pilote study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Marc Possover
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Marc Possover, Possover International Medical Center AG
- Investigators
- Marc Possover, Principal investigator, Possover International Medical Center AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231083
- Sponsor's protocol ID
- ED1
- Acronym
- GNS
- Status last verified
- May 2023
- First submitted
- 31 Dec 2021
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Stimulation of the Genital Nerves (GN) to Improve Erection Dysfunction (ED) in Men: a Pilot Study
- ClinicalTrials.gov ID
- NCT05231083
- Acronym / sponsor ID
- GNS / ED1
- Conditions
- Erectile Dysfunction
- Keywords
- erectile dysfunction, Genital Nerves Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Prof. Dr. med. Marc PossoverUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is a randomized prospective unblended study. 20 male patients with ED participated to the study. Vulnerable patients, patients with a pacemaker, patients with genital lesions, previous pudendal nerve or genital surgeries, vascular disease or neurological disorders are excluded. Due to the risk of iatrogenic lesions of the erectile nerves, patients suffering from ED secondary to radical prostatectomy are not prime candidates for such a study, however due to the incidence of this etiology and the important impact in the general male population, the investigators decided to include these patients in participants study. The assessment at baseline consistes of a medical history, a neuropelveological workup of the pelvic somatic nerves, pudendal ultrasonography with doppler. Stimulation is performed using a battery powered handled stimulator (N602-1C TENS Elektrostimulator - CH). Monophasic square constant current pulse with a pulse duration of 210 μs. The patients are randomized into two separate groups, a group A with fixed stimulation at 20Hz, a group B with fixed stimulation at 60Hz. Because both genital nerves are located just few millimeters below the skin, stimulation can be achieved using two adhesive skin surface electrodes (diameter 32mm, PALS Platinum, Axelgaard, Lystrup, Denmark), one placed at the root of the penis and in vicinity of the symphysis pubis as a cathode, and a second 2-3cm lateral to the penis. Precautions are taken to ensure good contact between skin and the electrodes, including removal of hairs. Furthermore, the patients are instructed to place the electrodes correctly and to clean the skin before application of the electrodes. The patients are encouraged to set the amplitude as high as tolerable each time when stimulating at home.
Because the different genital nerves may react to different frequency of stimulation , stimulation is delivered for 30 min at the maximal tolerable stimulation amplitude at 210μs pulse width with a pulse rate at 20Hz in patients group A, and at 60Hz in patients group B.
The first transcutaneous stimulation is performed in the presence of MP: The penile tumescence and rigidity observed during stimulation are recorded in both groups of patients. Then stimulation is performed at home at least twice daily for 15 min in each session for a period of 2 weeks. The patients recorde the stimulation amplitude after each session. Erection Harness Score (EHS) and Quality of Erection Questionnaire (QEQ) are assessed for 2 weeks before stimulation, during the 2 weeks of stimulation, and for 2 weeks after the final stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Monocebtric randomized unblinded pilote study
| Arm | Type | Receives |
|---|---|---|
| Arm A - 20Hz Stimulation | Experimental | Device: Genital Nerves StimulationTranscutaneous stimulation of the genital nerves at 20Hz |
| Arm B - 60Hz Stimulation | Experimental | Device: Genital Nerves StimulationTranscutaneous stimulation of the genital nerves at 60Hz |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting characteristic symptoms of refractory ED
Key exclusion criteria (6 listed)
- Patients<18y and >90y
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genital Nerves StimulationTranscutaneous electrical stimulation of the genital nerves using a TENS device and skin adhesive surface electrodes | Device | Arm A - 20Hz Stimulation, Arm B - 60Hz Stimulation |
Primary outcome
Transcutaneous electrical stimulation of the Genital Nerves for treatment ED
Time frame: 6 months
Examining the efficacy of transcutaneous genital nerve stimulation (TENS) in the treatment of ED utilizing the International Index of Erectile Function-15 score: A. Erectile function (Q1,2,3,4,5,15): Max score 30 B. Orgasmic function (Q9,19): Max score 10 C: Sexual desire (Q11,12): Max score 10 D: Intercourse satisfaction (Q6,7,8): Max score 15 E: Overall satisfaction (Q13,14): Max Score 10 IEEFscores <14 out of 39 in domain A (erectile function) may be considered for therapy and referred for specialist investigation.
1 secondary outcome
Quality of erection by using two different frequency of stimulation
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Possover principal investigator
Possover International Medical Center AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genital Nerves Stimulation in people with Erectile Dysfunction, run by Prof. Dr. med. Marc Possover at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Possover, PhD (+41797507995, m.possover@possover.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcutaneous electrical stimulation of the Genital Nerves for treatment ED (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.