| Methods |
RTC n=111 |
| Participants |
CAF |
| Interventions |
Botox 0.3u/kg vs. LIS
n = 111 |
| Outcomes |
Healing
Incontinence |
| Notes |
6 m0 f/u0 drop outs, but 6 cross over to LIS at 2 mo.
RNS
ITT + |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
RNS |
| Allocation concealment (selection bias) |
Unclear risk |
D ‐ Not used |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
|
| Selective reporting (reporting bias) |
Low risk |
appropriate outcomes/side effects reported |
| Other bias |
Low risk |
ITT+, 0 drop outs, |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
|
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
|
| Duration of Follow‐up 6 months or more |
Low risk |
6 months |
