Methods |
RCT. |
Participants |
Australia, N = 74 Intervention =40 (16 drop outs), control =34 ( 0 drop out) |
Interventions |
Treatment group ‐ individualised MD bladder rehabilitation programme. Control group: usual care. |
Outcomes |
UDI6, NDS,AUA, IIQ7 |
Notes |
Same group of patients as Khan 2008 with bladder issues. Length of follow up 12 months. 10 participants from control group received the intervention. Additional analysis for those who received treatment was performed |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Computer generated randomisation sequence stratified by EDSS score, with wait list control group. |
Allocation concealment (selection bias) |
Low risk |
Numbered opaque sealed envelopes used to conceal allocation. |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Treating personnel blinded but participants became blinded 8 months into the trial. |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Outcome assessors blinded. |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Overall there was 22% dropout and all were from the treatment group. |
Selective reporting (reporting bias) |
Low risk |
All pre‐specified primary and secondary outcomes reported. Additional analysis was performed comparing those who received and those who did not received the intervention, irrespective of the randomisation. |
Other bias |
High risk |
Analyses were not performed according to ITT. |