| Screening and baseline | Treatments | Follow–up | ||||||
---|---|---|---|---|---|---|---|---|---|
Visit | 0 | 1 | 2–7 | 8 | 9–15 | 16 | 17 | 18 | 19 |
Timeline (wk) | 0 | 1 | 1–4 | 4 | 5–8 | 8 | 12 | 20 | 32 |
Screening for eligibility | x | Â | Â | Â | Â | Â | Â | Â | Â |
Informed consent | x | Â | Â | Â | Â | Â | Â | Â | Â |
Demographic data and medical history | x | Â | Â | Â | Â | Â | Â | Â | Â |
Physical examination | x | Â | Â | Â | Â | Â | Â | Â | Â |
Urine analysis | x | Â | Â | Â | Â | Â | Â | Â | Â |
Random blood sugar | x | Â | Â | Â | Â | Â | Â | Â | Â |
UPT | x | Â | Â | Â | Â | x | Â | Â | Â |
Uroflowmetry with postvoid residual (ultrasound) | x | Â | Â | Â | Â | x | Â | Â | Â |
Randomization | Â | x | Â | Â | Â | Â | Â | Â | Â |
MS treatment | Â | x | x | x | x | x | Â | Â | Â |
Adverse events | Â | x | x | x | x | x | x | x | x |
Retreatment or new intervention | Â | Â | Â | Â | Â | Â | x | x | x |
ICIQ-UI-SF | x | Â | Â | x | Â | x | x | x | x |
Incontinence episode diary | x | Â | Â | x | Â | x | x | x | x |
1-hr pad test | x | Â | Â | x | Â | x | x | x | x |
PFMF (perineometer) | x | Â | Â | x | Â | x | x | x | x |
PGI-I | Â | Â | Â | x | Â | x | x | x | x |
ICIQ-LUTS-QoL | x | Â | Â | x | Â | x | x | x | x |
EQ-5D | x | Â | Â | x | Â | x | x | x | x |
Blinding assessment | Â | Â | Â | Â | Â | x | Â | Â | Â |