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

Erectile Dysfunction Clinical Trial

— NEEP  

Official title:

Short- and Medium-term Efficacy of Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction: a Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06397625
• Other study ID #: NEEP
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: April 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 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: April 15, 2025
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Electric Stimulation
• Erectile Dysfunction
• Pudendal Nerve

Intervention

Other:
• 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)
• Percutaneous electrical neurostimulation
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).

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)

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. — View Citation

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. — 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 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
Primary	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
Primary	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
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 and 3 months after the intervention.	4 months
Primary	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
Primary	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