Table 1.
Study design schedule
| 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 | ||||||||
| Informed consent | x | ||||||||
| Demographic data and medical history | x | ||||||||
| Physical examination | x | ||||||||
| Urine analysis | x | ||||||||
| Random blood sugar | x | ||||||||
| UPT | x | x | |||||||
| Uroflowmetry with postvoid residual (ultrasound) | x | x | |||||||
| Randomization | x | ||||||||
| MS treatment | x | x | x | x | x | ||||
| Adverse events | x | x | x | x | x | x | x | x | |
| Retreatment or new intervention | x | x | x | ||||||
| ICIQ-UI-SF | x | x | x | x | x | x | |||
| Incontinence episode diary | x | x | x | x | x | x | |||
| 1-hr pad test | x | x | x | x | x | x | |||
| PFMF (perineometer) | x | x | x | x | x | x | |||
| PGI-I | x | x | x | x | x | ||||
| ICIQ-LUTS-QoL | x | x | x | x | x | x | |||
| EQ-5D | x | x | x | x | x | x | |||
| Blinding assessment | x | ||||||||
Abbreviations: ICIQ-LUTS-QoL International Consultation on Incontinence Questionnaire–Lower Urinary Tract Symptoms Quality of Life, ICIQ-UI-SF International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form, MS magnetic stimulation, PFMF pelvic floor muscle function, PGI-I Patient Global Impression of Improvement, UPT urine pregnancy test