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

NCT06397612 | Active Not Recruiting

• 1 other identifier: Low-NEEP
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pudendal Nerve Injury; Erectile Dysfunction; Electric Stimulation

Keywords

Erectile Dysfunction; Percutaneous Electrical Neurostimulation; Low Dose; Pudendal Nerve

Outcome Measures

Primary Outcomes (5)

• International Index of Erectile Function (IIEF-EF)

  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.

  4 months

• Erection Hardness Scale (EHS)

  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.

  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, three months after the intervention.

  4 months

• Quality of Life Scale

  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.

  4 months

• Self-Esteem And Relationship Questionnaire (Sear)

  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.

  4 months

Study Arms (1)

Group I

EXPERIMENTAL

The intervention protocol for Group I peripheral nerve electrostimulation will have the following parameters: 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.

Other: Low Dose

Interventions

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.

Group I

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Camilo Jose Cela University: lead

Study Sites (1)

LYX Instituto de Urología

Madrid, 28006, Spain

Location

Related Publications (3)

• 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

• Beltra P, Ruiz-Del-Portal I, Ortega FJ, Valdesuso R, Delicado-Miralles M, Velasco E. Sensorimotor effects of plasticity-inducing percutaneous peripheral nerve stimulation protocols: a blinded, randomized clinical trial. Eur J Pain. 2022 May;26(5):1039-1055. doi: 10.1002/ejp.1928. Epub 2022 Mar 3.

  PMID: 35191131 BACKGROUND

• Peters KM, Carrico DJ, Perez-Marrero RA, Khan AU, Wooldridge LS, Davis GL, Macdiarmid SA. Randomized trial of percutaneous tibial nerve stimulation versus Sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 2010 Apr;183(4):1438-43. doi: 10.1016/j.juro.2009.12.036. Epub 2010 Feb 20.

  PMID: 20171677 BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Contraceptives, Oral

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Álvaro Navas Mosqueda

  Camilo Jose Cela Univerity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study corresponds to a non-randomized, single treatment arm, prospective, multicenter study. The subject, the assignor, the physiotherapist, the statistician and a person in charge of activating the protocol will know the stimulation parameters, to adjust, monitor and apply the treatment.

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: December 1, 2023
• Primary Completion: April 15, 2026
• Study Completion (Estimated): August 28, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)