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

Not Applicable

Active, not recruiting

• Conditions: Pudendal Nerve; Electric Stimulation; Erectile Dysfunction
• Interventions: Other: Percutaneous electrical neurostimulation (Placebo); Other: Percutaneous electrical neurostimulation

• Registration Number: NCT06397625
• Lead Sponsor: Camilo Jose Cela University

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2024-03-20
• Study First Submitted: 2024-04-29
• Study First Submitted QC: 2024-05-01
• Study First Posted: 2024-05-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-04-05
• Study Completion: 2025-04-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group (Placebo)	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), 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.
Group (20 Hertz)	Percutaneous electrical neurostimulation	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.
Group 3 (50 Hertz)	Percutaneous electrical neurostimulation	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.

Primary Outcome Measures

Name	Time	Method
Intravaginal Latency Time (IELT)	4 months	Time to ejaculation is considered and should be between 3 and 6 minutes. A duration of less than one minute is considered premature ejaculation, and a duration between one minute and one and a half minutes is considered probable premature ejaculation. Measurement pre-, one week after the intervention, one month after the intervention and 3 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 and 3 months after the intervention.
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 widely recognized and used, and consists of six questions in which the frequency and firmness of erection, penetration capacity, capacity and frequency of maintenance and confidence in 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 and 3 months after the intervention.
Self-Esteem And Relationship Questionnaire (Sear)	4 months	It is a questionnaire used for research and/or clinical practice on self-esteem, in this case for patients with erectile dysfunction. Measurement pre-, one week after the intervention, one month after the intervention and 3 months after the intervention. The scale is measured from 0 to 100 points, with 0 being the worst score and 100 being the best.
Erection Hardness Scale (EHS)	4 months	significant changes will be considered to be those 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 and 3 months after the intervention.
Quality of Life Scale	4 months	It is used to know in a subjective way, the patient's opinion regarding his/her quality of life, according to 4 main aspects: physical, psychological, social and environmental health. Measurement pre-, one week after the intervention, one month after the intervention and 3 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.

Trial Locations

Locations (1)

LYX Instituto de Urología; 🇪🇸 Madrid, Spain