Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction. (Low-NEEP)

Camilo Jose Cela University

Status: Active, not recruiting

Conditions: Pudendal Nerve Injury; Erectile Dysfunction; Electric Stimulation

Treatments: Other: Low Dose

Study type: Interventional

Funder types: Other

Identifiers

NCT06397612

Low-NEEP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Group I

Experimental group

Description:

The intervention protocol for Group I peripheral nerve electrostimulation will have the following parameters: 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.

Treatment:

Other: Low Dose