Viewing Study NCT06397625



Ignite Creation Date: 2024-05-06 @ 8:29 PM
Last Modification Date: 2024-10-26 @ 3:28 PM
Study NCT ID: NCT06397625
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-05-13
First Post: 2024-04-29

Brief Title: Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction
Sponsor: Camilo Jose Cela University
Organization: Camilo Jose Cela University

Study Overview

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
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: NEEP
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None