Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction (NEEP)

Camilo Jose Cela University

Status: Active, not recruiting

Conditions: Pudendal Nerve; Erectile Dysfunction; Electric Stimulation

Treatments: Other: Percutaneous electrical neurostimulation (Placebo); Other: Percutaneous electrical neurostimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06397625

NEEP

Details and patient eligibility

About

Erectile dysfunction is known as any alteration that produces a modification in the erectile response, whether of organic, psychogenic or relational cause. In this case the pudendal nerve is addressed, since it has its origin in the sacral plexus, deriving from the S2, S3 and S4 nerve branches. Its fibers have different innervation, being the pudendal nerve a mixed nerve, and estimating that it has 30% of autonomic innervation, and 70% of somatic innervation (50% sensory and 20% motor). Peripheral percutaneous nerve stimulation (proposed treatment) is performed with 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 of the deeper tissues.

Full description

The study corresponds to an experimental, prospective, multicenter, randomized, prospective clinical trial. According to the Granmo program, it has been calculated to recruit 72 subjects with erectile dysfunction, recruited from different leading urology and andrology centers such as Clínica LYX (Instituto de Urología de Madrid). Patients will voluntarily accept to be part of the study, and will be able to ask the principal investigator any questions they may have at any time. The intervention will be performed at the LYX Clinic (Urology Institute).

Enrollment: 72 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men
• Ages 18-60 years old
• Primarily organic cause diagnosed by Doppler:

Peak-systolic velocities (PSV). Tele-diastolic velocity (DTV). Resistance Index (IR)

• Initial IIEF-EF questionnaire scores: 1-25 points (mild, moderate or severe erectile dysfunction).
• Active sex 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
• Women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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72 participants in 3 patient groups, including a placebo group

Group (Placebo)

Placebo Comparator group

Description:

Group I (Control), will be operated with the same procedure but without electric current, and using "placebo needles" of the same size (Streitberger Placebo-Needle ® , Asiamed, Pullach, Germany), which will not pierce the surface of the patient's skin, but will cause a prick sensation. This process will be developed by resting the needle on the skin of the patient's perineum and pushing the handle of the needle until it touches the surface of the skin, producing in the patient the impression of penetration, although this is not the case.

Treatment:

Other: Percutaneous electrical neurostimulation (Placebo)

Group (20 Hertz)

Experimental group

Description:

Group II 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.

Treatment:

Other: Percutaneous electrical neurostimulation

Group 3 (50 Hertz)

Experimental group

Description:

Group III, will be intervened with continuous stimulation at a frequency of 50 Hz,a pulse width of 200 μs (18) and for a total of 20 minutes. The intensity will be set at the maximum tolerable threshold. In case the patient does not tolerate the treatment, due to increased fatigue, the 50 hertz will be alternated with the 20 hertz in bursts.

Treatment:

Other: Percutaneous electrical neurostimulation