|
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 |