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Active, Not Recruiting

NCT Number: NCT06397612

Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.

Erectile dysfunction is known as any alteration that produces a modification in the erectile response, whether it is due to organic, psychogenic or relational causes. Peripheral percutaneous nerve stimulation is performed using 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 in the deeper tissues.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pudendal Nerve Injury Electric Stimulation Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

LYX Instituto de Urología

Madrid, 28006, Spain

About this study

Patients 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, observing significant changes in erectile function after transanal stimulation at intensities between 20 and 100 mA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Males Ages between 18-60 years old

Primarily organic cause diagnosed by Doppler:

  • Peak-systolic velocities (PSV).
  • Tele-diastolic velocity (DTV).
  • Resistance Index (RI) Patients with ≤ 6 months since first assessment. Initial IIEF-EF questionnaire scores: 11-25 points. (mild to moderate erectile dysfunction) Active sexual 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 Female

Treatment and study plan

Low Dose

Other

Patients will be intervened with stimulation continuously, 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.

Primary outcomes

  1. International Index of Erectile Function (IIEF-EF)

    Time frame: 4 months

    It is an index that assesses erectile function in a purely subjective way. It is the most recognized and used, and consists of six questions in which the frequency and firmness of the erection, the capacity of penetration, the capacity and frequency of maintenance and the confidence in the 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, three months after the intervention.

  2. Erection Hardness Scale (EHS)

    Time frame: 4 months

    The following will be considered significant changes 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, three months after the intervention.

  3. Premature Ejaculation Diagnostic Tool (PEDT)

    Time frame: 4 months

    Helps identify patients who may be suffering from premature ejaculation. Measurement pre, one week after the intervention, one month after the intervention, three months after the intervention.

  4. Quality of Life Scale

    Time frame: 4 months

    It is used to subjectively assess the patient's opinion of his or her quality of life, based on 4 main aspects: physical, psychological, social and environmental health.Measurement pre, one week after the intervention, one month after the intervention, three 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.

  5. Self-Esteem And Relationship Questionnaire (Sear)

    Time frame: 4 months

    A questionnaire used for research and/or clinical practice use on self-esteem, in this case for patients with erectile dysfunction. Measurement pre, one week after the intervention, one month after the intervention, three months after the intervention. The scale is measured from 0 to 100 points, with 0 being the worst score and 100 being the best.

Sponsors and collaborators

Lead sponsor

Camilo Jose Cela University

Other

Registry information

Official study title

Registry on the Short- and Medium-term Efficacy of Low-dose Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Pudendal Nerve in Patients With Erectile Dysfunction

Acronym: Low-NEEP

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 3, 2024
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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