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

NCT06397625 | Active Not Recruiting

• 1 other identifier: NEEP
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Pudendal Nerve; Erectile Dysfunction; Electric Stimulation

Keywords

Erectile Dysfunction; Percutaneous Electrical Neurostimulation; Pudendal Nerve

Outcome Measures

Primary Outcomes (6)

• International Index of Erectile Function (IIEF-EF)

  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.

  4 months

• Erection Hardness Scale (EHS)

  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.

  4 months

• Intravaginal Latency Time (IELT)

  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.

  4 months

• Premature Ejaculation Diagnostic Tool (PEDT)

  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.

  4 months

• Quality of Life Scale

  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.

  4 months

• Self-Esteem And Relationship Questionnaire (Sear)

  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.

  4 months

Study Arms (3)

Group (Placebo)

PLACEBO COMPARATOR

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.

Other: Percutaneous electrical neurostimulation (Placebo)

Group (20 Hertz)

EXPERIMENTAL

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.

Other: Percutaneous electrical neurostimulation

Group 3 (50 Hertz)

EXPERIMENTAL

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.

Other: Percutaneous electrical neurostimulation

Interventions

Percutaneous electrical neurostimulation (Placebo) OTHER

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)

Group (Placebo)

Percutaneous electrical neurostimulation OTHER

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).

Group (20 Hertz); Group 3 (50 Hertz)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Pelvic surgeries
• History of Peyronie's disease
• Penile surgeries, except circumcision or frenuloplasty
• Priapism
• Pelvic radiation
• Women

Sponsors & Collaborators

• Camilo Jose Cela University: lead

Study Sites (1)

LYX Instituto de Urología

Madrid, 28006, Spain

Location

Related Publications (3)

• Rislanu A, Auwal H, Musa D, Auwal A. Comparative Effectiveness of Electrical Stimulation and Aerobic Exercise in the Management of Erectile Dysfunction: A Randomized Clinical Trial. Ethiop J Health Sci. 2020 Nov;30(6):961-970. doi: 10.4314/ejhs.v30i6.14.

  PMID: 33883841 BACKGROUND

• Carboni C, Fornari A, Bragante KC, Averbeck MA, Vianna da Rosa P, Mea Plentz RD. An initial study on the effect of functional electrical stimulation in erectile dysfunction: a randomized controlled trial. Int J Impot Res. 2018 Jun;30(3):97-101. doi: 10.1038/s41443-018-0024-8. Epub 2018 May 22.

  PMID: 29785045 BACKGROUND

• Yafi FA, Jenkins L, Albersen M, Corona G, Isidori AM, Goldfarb S, Maggi M, Nelson CJ, Parish S, Salonia A, Tan R, Mulhall JP, Hellstrom WJ. Erectile dysfunction. Nat Rev Dis Primers. 2016 Feb 4;2:16003. doi: 10.1038/nrdp.2016.3.

  PMID: 27188339 BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Álvaro Navas Mosqueda

  Camilo Jose Cela Univerity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 3, 2024
• Study Start: March 20, 2024
• Primary Completion: February 25, 2026
• Study Completion: February 28, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)