Background
Methods and design
Study design
Study locations
Study population and recruitment
Inclusion criteria | |
Age > 18 years | |
Ability to implant device less than 12 weeks post-SCI | |
Presence of acute SCI at or above T12 | |
ASIA scale A or B | |
Expectation to perform CIC personally or have caretaker perform CIC | |
Medically stable to discharge to a rehab setting | |
Exclusion criteria | |
Inability to perform CIC or have caregiver perform it | |
Pre-existing SCI | |
Pre-existing progressive neurological disorder | |
Autonomic dysreflexia | |
Prior sacral back surgery | |
Posterior pelvic fracture with distortion of the sacroiliac joint | |
Prior urethral sphincter or bladder dysfunction | |
Chronic urinary tract infections prior to SCI | |
Pregnancy at the time of enrollment | |
Presence of coagulation disorder or need for anticoagulation that they connot be stopped temporarily for procedure | |
Any significant co-morbidity or illness that would preclude their participation or increase the risk to them having a surgical procedure | |
Active untreated infection | |
Traumatic injury to the genitourinary system | |
Prior pelvic radiation, bladder cancer or other surgical procedure to the bladder that would effect baseline bladder physiology |
Investigations
Collection method | Time points (month) | Variable type | Analyzed At | |
Urodynamic parameters – aim 1 | ||||
Primary | ||||
Maximum cystometric capacity | UDS | 0,12 m | Continuous | 12 m |
Secondary | ||||
Maximum cystometric at 3 months | UDS | 0,3 m | Continuous | 3 m |
Bladder compliance | UDS | 0,3,12 m | Continuous | 3 m, 12 m |
Presence of detrusor overactivity | UDS | 0,3,12 m | Binary | 3 m, 12 m |
Volume & pressure at first detrusor contraction | UDS | 0,3,12 m | Continuous | 3 m, 12 m |
Quality of Life – Aim 2 | ||||
Primary | ||||
Difference in mean NBSS, SCI-QoL questionnaires | Questionnaire | 3,6,9,12 m | Continuous | 3,6,9,12 m |
Secondary | ||||
Daily number of catheterizations, | Bladder diary | 3,6,9,12 m | Continuous | 3,6,9,12 m |
Average catheterization volume, | Bladder diary | 3,6,9,12 m | Continuous | 3,6,9,12 m |
Urinary incontinence episodes per day | Bladder diary | 3,6,9,12 m | Continuous | 3,6,9,12 m |
24 h pad weight test | 24 h pad | 3,6,9,12 m | Continuous | 3,6,9,12 m |
Clinical – Aim 3 | ||||
Primary | ||||
# of UTIs requiring antibiotics | Chart review | 12 m | Continuous | 12 m |
Secondary | ||||
Development of hydronephrosis | Renal ultrasound | 12 m | Categorical | 12 m |
Need for anticholinergic medication | Chart review | 12 m | Binary | 12 m |
Botulinum toxin injection | Chart review | event | Binary | 12 m |
Need for device revision | Chart review | event | Binary | 12 m |
Device explanation | Chart review | event | Binary | 12 m |
Use of medications / mechanical bowel stimulation | Chart review | event | Continuous | 12 m |
SHIM | Chart review | event | Continuous | 12 m |
Erectile dysfunction medications | Chart review | event | Continuous | 12 m |
Safety
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Maintenance of sterile procedure and use of a double prep with an iodine skin protective cover.
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Placement of electrodes appropriately using fluoroscopy in the S3 foramen.
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Adequate testing for motor response indicating close proximity of the nerve and appropriate placement in the S3 foramen.
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Correctly attaching electrodes to the IPG device and tunneling of electrodes.
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Appropriate closure of all incisions in a manner consistent with preventing erosions of the electrodes or generator.