Genital Nerves Stimulation for Treatment for Erectile Dysfunction

NCT05231083 | Unknown DMC

• 1 other identifier: ED1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erectile Dysfunction

Keywords

erectile dysfunction; Genital Nerves Stimulation

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  6 months

Secondary Outcomes (1)

• Quality of erection by using two different frequency of stimulation

  60 months

Study Arms (2)

Arm A - 20Hz Stimulation

EXPERIMENTAL

Transcutaneous stimulation of the genital nerves at 20Hz

Device: Genital Nerves Stimulation

Arm B - 60Hz Stimulation

EXPERIMENTAL

Transcutaneous stimulation of the genital nerves at 60Hz

Device: Genital Nerves Stimulation

Interventions

Genital Nerves Stimulation DEVICE

Transcutaneous electrical stimulation of the genital nerves using a TENS device and skin adhesive surface electrodes

Arm A - 20Hz Stimulation; Arm B - 60Hz Stimulation

Eligibility Criteria

• Age: 19 Years - 90 Years
• Gender Eligibility Details: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting characteristic symptoms of refractory ED

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof. Dr. med. Marc Possover: lead

Study Sites (1)

Possover

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Marc Possover

  Possover International Medical Center AG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Possover, PhD

CONTACT

+41797507995; m.possover@possover.com

Marc Possover

CONTACT

+415203600; mail@possover.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Department of Neuropelveology & Operative Gynecology

Model Details: Monocebtric randomized unblinded pilote study

Study Record Dates

• First Submitted: December 31, 2021
• First Posted: February 9, 2022
• Study Start: February 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

CH (1)