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

Erectile Dysfunction Clinical Trial

— Low-NEEP  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06397612
• Other study ID #: Low-NEEP
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: January 15, 2025

Study information

• Verified date: April 2024
• Source: Camilo Jose Cela University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: January 15, 2025
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Electric Stimulation
• Erectile Dysfunction

Intervention

Other:
• Low Dose
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.

Locations

Country	Name	City	State
Spain	LYX Instituto de Urología	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Camilo Jose Cela University

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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