Table 2 Primary and secondary outcome variables. UDS (urodynamic study), NBSS (Neurogenic Bladder Symptom Score), SCI-QoL (spinal cord injury quality of life measurement system bladder management difficulties and bladder complications), SHIM (sexual health inventory for men)
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 |