Thoracic traumatic spinal cord injury, sequelae of injury of spinal cord
Conditions
Interventions
Study group: 20 persons with traumatic spinal cord injury will receive the neuromodulator implant on the sciatic, pudendal and femoral nerves laparoscopically and two weekly sessions of motor physical
Device
Procedure/surgery
E02.779
Sponsors
Hospital São Paulo - Hospital Universitário da Universidade Federal de São Paulo
Universidade Federal de São Paulo
Hospital São Paulo - Hospital Universitário da Universidade Federal de São Paulo
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Individuals aging 18 to 60 years, with partial or complete spinal cord injury ASIA (American Spinal Injury Association) score A or B, in clean intermitent self-catheterization and/or with urinary incontinence and neurologically stable for more than one year.
Exclusion criteria
Exclusion criteria: Subjects with the following characteristics will be excluded: urodynamic bladder atonia; suspicion of vesicoureteral reflux prior to the spinal cord injury; Diabetes Mellitus, compensated or not; congenital or acquired immunodeficiency; known or suspected malignancy; history of rectossigmoidectomy, colectomy, or other gastrointestinal surgeries that can cause changes in bowel habits, stool anal continence or function; history of surgical treatment of uterovaginal prolapse, urinary incontinence, bladder augmentation procedures or other procedures associated with dysfunctional voiding (urethrotomy etc.); history of prostatectomy, transurethral resection of the prostate or prostatic other invasive procedures except biopsy; history of central or peripheral procedures neuroablative as rizotomy, cordotomy etc.; uterovaginal prolapse, rectal or urethral; cystostomy; anal or urethral stenosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase on maximum cystometric capacity and bladder compliance as assessed by urodynamic study; increase on voided volume and decrease on the number of incontinence episodes and need for bladder catheterization; improvement of quality of life related to bladder function, as assessed by the Qualiveen questionnaire; improvement in spasticity as assessed by the SCATS system (Spinal Cord Assessment Tool for Spastic Reflexes) | — |
Secondary
| Measure | Time frame |
|---|---|
| Increased rectal sensitivity and capacity evaluated by intrarretal balloon; improvement of pelvic floor muscle function measured by digital palpation and intracavitary electromyography; improved sexual function in men evaluated by International Index of Erectile Function questionnaire, and in women at the Female Sexual Function Index questionnaire; histological changes of the femoral rectus muscles by biopsy; increased active range of motion of the lower limbs and trunk measured by goniometry; changes in patterns of gait and balance evaluated by Barthel scale; improvement in overall sleep quality assessed by the Pittsburgh questionnaire validated Brazilian Portuguese and also of daytime sleepiness measured by the Epworth questionnaire validated for the Brazilian Portuguese; improved body image assessed by testing the Human Figure Drawing. | — |
Countries
Brazil
Contacts
Public ContactNucelio Lemos
Universidade Federal de São Paulo
Outcome results
None listed