Evaluation of the Impact of neuromodulators on urinary, intestinal and sexual functions and on spasticity in spinal cord injured individuals

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-4w6v2c
• Date of registration: 14/07/2014
• Prospective Registration: Yes
• Primary sponsor: Hospital São Paulo - Hospital Universitário da Universidade Federal de São Paulo
• Public title: Evaluation of the Impact of neuromodulators on urinary, intestinal and sexual functions and on spasticity in spinal cord injured individuals
• Scientific title: Impact of lumbosacral plexus stimulation by means of laparoscopically implanted eletrodes on urinary, intestinal and vasomotor functions and on lower limb and pelvic floor spasticity and sleep quality in spinal cord injured individuals
• Date of first enrolment: 01/11/2014
• Recruitment status: Not yet recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-4w6v2c
• Study type: Intervention
• Study design: Clinical trial, therapeutic, parallel, open, randomized controlled, two arms
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Nucelio Luiz de Barros Moreira Lemos
• Affiliation: Universidade Federal de São Paulo

• Name: Nucelio Luiz de Barros Moreira Lemos
• Affiliation: Universidade Federal de São Paulo

Key inclusion & exclusion 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: 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.

Age minimum: 18Y
Age maximum: 60Y
Gender: -

Health Condition(s) or Problem(s) studied

T91.3

Thoracic traumatic spinal cord injury, sequelae of injury of spinal cord

Intervention(s)

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 therapy and one weekly session of pelvic floor physiotherapy for 12 months. Control group: 20 persons with traumatic spinal cord injury receive only the two weekly sessions of physical therapy and a weekly session of pelvic floor physiotherapy, 12 months

Procedure/surgery

E04.650

Device

E02.779

Primary Outcome(s)

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(s)

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.

Source(s) of Monetary Support

Medtronic

Secondary Sponsor(s)

Hospital São Paulo - Hospital Universitário da Universidade Federal de São Paulo

Universidade Federal de São Paulo