Status:
UNKNOWN
Genital Nerves Stimulation for Treatment for Erectile Dysfunction
Lead Sponsor:
Prof. Dr. med. Marc Possover
Conditions:
Erectile Dysfunction
Eligibility:
MALE
19-90 years
Phase:
NA
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 pres...
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 puden...
Eligibility Criteria
Inclusion
- Patients presenting characteristic symptoms of refractory ED
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05231083
Start Date
February 1 2025
End Date
September 1 2025
Last Update
May 6 2023
Active Locations (1)
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1
Possover
Zurich, Switzerland, 8008