Clinical trial NCT06397625: Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Erectile Dysfunction
Electric Stimulation
Pudendal Nerve
Keywords: Erectile Dysfunction
Percutaneous Electrical Neurostimulation
Pudendal Nerve
Lead sponsor: Camilo Jose Cela University
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: International Index of Erectile Function (IIEF-EF)
timeFrame: 4 months
measure: Erection Hardness Scale (EHS)
timeFrame: 4 months
measure: Intravaginal Latency Time (IELT)
timeFrame: 4 months
measure: Premature Ejaculation Diagnostic Tool (PEDT)
timeFrame: 4 months
measure: Quality of Life Scale
timeFrame: 4 months
measure: Self-Esteem And Relationship Questionnaire (Sear)
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: LYX Instituto de Urología
Study officials:
affiliation: Camilo Jose Cela Univerity
name: Álvaro Navas Mosqueda
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.