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Active Not Recruiting
NCT06397625
Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction
Conditions: Erectile Dysfunction, Electric Stimulation, Pudendal Nerve
Sex: Male
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 72
Sponsor: Camilo Jose Cela University
Location: LYX Instituto de Urología Madrid
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT06397625). StuddyBuddy aggregates publicly available trial information.