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

NCT06397625 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-01-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Percutaneous electrical neurostimulation (Placebo)

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)

OTHER

Percutaneous electrical neurostimulation

The Group II and III electrostimulation procedure is called peripheral nerve stimulation and is known as an echo-guided peripheral nerve stimulation technique using a blunt, dry needle (active electrode). The intervention will be performed on the pudendal nerve, in an area where there is no risk of perforating any vascular-nerve bundle. The invasive technique will be performed by a physiotherapist expert in musculoskeletal and peripheral nervous system ultrasound and specialized in invasive techniques, with two years of experience in the sector. The needle will be introduced through the anterior (perineum).

Sponsors & Collaborators

  • Camilo Jose Cela University

    lead OTHER

Principal Investigators

  • Álvaro Navas Mosqueda · Camilo Jose Cela Univerity

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-20
Primary Completion
2026-02-25
Completion
2026-02-28

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06397625 on ClinicalTrials.gov