Table 2 List of outcomes and assessment measures with time points
Outcome measure | Assessed by: | Assessed at: |
|---|---|---|
Primary | ||
Overactive bladder symptoms | ICIQ-OAB part A [24] | Weeks 0–12, 16, 20, 24 |
Secondary | ||
Overall patient-perceived benefit | Global Rating of Change score (GRC) | Week 13 |
Bladder-related quality of life | ICIQ-OAB part B | Weeks 0–12, 16, 20, 24 |
ICIQ-OABqol [25] | Week 0,13 | |
Mood | Patient Health Questionnaire (PHQ9-) [26] | Week 0,13 |
General bladder symptom profile | Frequency of incontinence and urgency episodes (bladder diary) | Week 0,13 |
Frequency of nocturia (bladder diary) | ||
Autonomic symptoms | Scales for Outcomes in Parkinson’s Disease- Autonomic (SCOPA-AUT) [28] | Week 0,13 |
Bowel symptoms | Neurogenic bowel score [29] | Week 0,13 |
Urodynamic parameters | Post-void residual (ultrasound) | Week 0,13 |
Nocturnal polyuria index (bladder diary) | ||
Corrected Qmax (uroflowmetery) | ||
Tolerabillity of Geko™ device | Stimulation Diaries | Throughout intervention period |