RBR-4ngnx3b
Not yet recruiting
未知
Safety and Tolerability of a novel implantable Nerve Stimulator to ameliorate Erectile Function: a first study in men living with Spinal Cord Injury
E Pizolato Preparacao de Documentos e Servicos Especializados de Apoio Administrativo0 sitesMay 8, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Erectile function
- Sponsor
- E Pizolato Preparacao de Documentos e Servicos Especializados de Apoio Administrativo
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men; 18 to 55 years old; traumatic spinal cord injury; injury less than 1 year ago; treat erectile dysfunction; responsive to PDE5 inhibitors; IIEF\-15 score is equal to or less than 25 points.
Exclusion Criteria
- •Spinal injury at T6 or above; history of autonomic dysreflexia; known allergies to any device material (Platinum/Iridium, Silicone, Pellethane, Titanium, Polysulfone, Polyurethane); contraindicated for surgery under general anesthesia; PSA greater than 4\.0ng/mL; priapism or Peyronie's disease; hypertension; previous pelvic surgery; irradiation therapy; current use of an implantable penile device; diagnosed with a progressive degenerative neurological disease that can negatively impair erectile function; diabetes mellitus suffering from peripheral neuropathy or other complications associated with diabetes; not interested in sexual activity; currently participate in other clinical investigations; depression or abnormal behavior; IIEF\-15 score equal to or greater than 26 points; high risk of prostate cancer, as determined by a positive PSA test.
Outcomes
Primary Outcomes
Not specified
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