Evaluation of the Impact of neuromodulators on urinary, intestinal and sexual functions and on spasticity in spinal cord injured individuals
- Conditions
- Thoracic traumatic spinal cord injury, sequelae of injury of spinal cordT91.3
- Registration Number
- RBR-4w6v2c
- Lead Sponsor
- Hospital São Paulo - Hospital Universitário da Universidade Federal de São Paulo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.