erve Stimulator implantable to ameriolate Erectile Function in men living with Spinal Cord Injury

Not Applicable

• Conditions: Erectile function; Spinal cord injury; C10.900

• Registration Number: RBR-4ngnx3b
• Lead Sponsor: E Pizolato Preparacao de Documentos e Servicos Especializados de Apoio Administrativo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-08
• Last Update Posted: 29 May 2023
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>Pain will be routinely assessed by asking the subject to rate pain from 0 to 10 on a visual analogue scale (VAS).<br>Complications related to the surgical procedure itself will be evaluated and classified according to the Clavien-Dindo Classification. <br><br><br>Pain will be routinely evaluated by asking the subject to rate pain from 0 to<br>10 on a visual analog scale (EVA).<br>Complications related to the surgical procedure itself will be evaluated and<br>classified according to the Clavien-Dindo Classification.

Secondary Outcome Measures

Name	Time	Method
o secondary outcomes are expected.