Erectile function
Conditions
Interventions
This is an open-label, single-arm clinical study. A total of 20 people meeting the eligibility criteria will be allocated to receive the medical device implant. Both the researchers evaluating the end
Sponsors
E Pizolato Preparacao de Documentos e Servicos Especializados de Apoio Administrativo
Fundação do ABC
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find an improvement in erectile function, in a general and permanent way, evaluating the safety of the CaverSTIM device through the application of specific questionnaires and the systematic analysis of device deficiencies, adverse events, serious adverse events by monitoring the frequency, severity and incidence of these events. Pain will be routinely assessed by asking the subject to rate pain from 0 to 10 on a visual analogue scale (VAS). Complications related to the surgical procedure itself will be evaluated and classified according to the Clavien-Dindo Classification. Pain will be routinely evaluated by asking the subject to rate pain from 0 to 10 on a visual analog scale (EVA). Complications related to the surgical procedure itself will be evaluated and classified according to the Clavien-Dindo Classification. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected. | — |
Countries
Brazil
Contacts
Public ContactRodrigo da Silva
Comphya SA
Outcome results
None listed