Clinical trial NCT06397612: Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pudendal Nerve Injury
Erectile Dysfunction
Electric Stimulation
Keywords: Erectile Dysfunction
Percutaneous Electrical Neurostimulation
Low Dose
Pudendal Nerve
Lead sponsor: Camilo Jose Cela University
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: International Index of Erectile Function (IIEF-EF)
timeFrame: 4 months
measure: Erection Hardness Scale (EHS)
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: 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.
citation: 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.
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.