Pudendal Nerve Injury, Erectile Dysfunction, Electric Stimulation
Conditions
Keywords
Erectile Dysfunction, Percutaneous Electrical Neurostimulation, Low Dose, Pudendal Nerve
Brief summary
Erectile dysfunction is known as any alteration that produces a modification in the erectile response, whether it is due to organic, psychogenic or relational causes. Peripheral percutaneous nerve stimulation is performed using a needle to stimulate the peripheral nerves in such a way as to stimulate most of the area of the structure, stimulating sensory and motor nerve endings in the deeper tissues.
Detailed description
Patients will undergo continuous stimulation at a frequency of 20 Hertz, a pulse width of 200 µs and for a total of 20 minutes. The intensity will be set at the maximum tolerated by the patient, observing significant changes in erectile function after transanal stimulation at intensities between 20 and 100 mA.
Interventions
OTHERLow Dose
Patients will be intervened with stimulation continuously, at a frequency of 20 Hertz, a pulse width of 200 µs and for a total of 20 minutes. The intensity will be set at the maximum tolerated by the patient.
Sponsors
Camilo Jose Cela University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study corresponds to a non-randomized, single treatment arm, prospective, multicenter study. The subject, the assignor, the physiotherapist, the statistician and a person in charge of activating the protocol will know the stimulation parameters, to adjust, monitor and apply the treatment.
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Males Ages between 18-60 years old Primarily organic cause diagnosed by Doppler: * Peak-systolic velocities (PSV). * Tele-diastolic velocity (DTV). * Resistance Index (RI) Patients with ≤ 6 months since first assessment. Initial IIEF-EF questionnaire scores: 11-25 points. (mild to moderate erectile dysfunction) Active sexual life (more than 4 attempts per month).
Exclusion criteria
Pelvic surgeries History of Peyronie's disease Penile surgeries, except circumcision or frenuloplasty Priapism Pelvic radiation Female
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Index of Erectile Function (IIEF-EF) | 4 months | It is an index that assesses erectile function in a purely subjective way. It is the most recognized and used, and consists of six questions in which the frequency and firmness of the erection, the capacity of penetration, the capacity and frequency of maintenance and the confidence in the erection are evaluated. According to the questionnaire, dysfunction is classified as: no ED (26-30 points), mild (22-25 points), mild to moderate (17-21 points), moderate (11-16 points) and very strong (6-10 points). A score equal to or greater than 4 points will be considered a significant change. Measurement pre, one week after the intervention, one month after the intervention, three months after the intervention. |
| Erection Hardness Scale (EHS) | 4 months | The following will be considered significant changes men who improved by more than 3 points what in the initial phase was below a score of 2 points. The questionnaire score depends on the rating of erection hardness according to the following parameters: 0 (penis does not enlarge); 1 (penis is larger, but not hard); 2 (penis is hard but not hard enough for penetration); 3 (penis is hard enough to penetrate, but not completely hard); and 4 (penis is completely hard and rigid). Measurement pre, one week after the intervention, one month after the intervention, three months after the intervention. |
| Premature Ejaculation Diagnostic Tool (PEDT) | 4 months | Helps identify patients who may be suffering from premature ejaculation. Measurement pre, one week after the intervention, one month after the intervention, three months after the intervention. |
| Quality of Life Scale | 4 months | It is used to subjectively assess the patient's opinion of his or her quality of life, based on 4 main aspects: physical, psychological, social and environmental health.Measurement pre, one week after the intervention, one month after the intervention, three months after the intervention. The scale is measured by 26 items, divided into 4 dimensions. Each dimension is independent. The higher the score, the higher the patient's quality of life. |
| Self-Esteem And Relationship Questionnaire (Sear) | 4 months | A questionnaire used for research and/or clinical practice use on self-esteem, in this case for patients with erectile dysfunction. Measurement pre, one week after the intervention, one month after the intervention, three months after the intervention. The scale is measured from 0 to 100 points, with 0 being the worst score and 100 being the best. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORÁlvaro Navas Mosqueda
Camilo Jose Cela Univerity
Outcome results
None listed