Filocamo 2005.

Methods	Randomised: yes Method of allocation: block randomisation, block size of 4 for 2 groups (A and B) with only one permutation code (ABBA) Blinding: not described Dropouts: at 12 months, 2 participants dropped out of the control group Intention to treat: yes
Participants	Recruitment: post‐operative Included: all men undergoing RRP N = 300 consecutive men post RRP, randomised after catheter removal to 2 groups Intervention group: N = 150 Control group: N = 150
Interventions	Post‐operative intervention Group A (150) intervention: formal instruction (3 treatment sessions plus at home exercises) in PFMT using verbal explanation, palpation and visualization of the base of the penis with a mirror, in different positions and prior to sneezing, coughing or lifting Group B (150) control: no formal instruction Length of follow‐up: 12 months
Outcomes	Main outcome: urine loss on 1 hour and 24 hour pad tests plus number of pads used daily Continence definition: 0 to 1 pads per day Data collection: 1, 3, 6, and 12 months Wet (leakage or use of pads) 1 month: A 145/150, B 147/150 3 months: A 115/150, B 129/150 6 months: A 35/150, B 102/150 12 months: A 16/150, B 49/148 Surgical implantation of artificial urinary sphincter: A 2/150, B 3/148
Notes	74% of the intervention group achieved continence at 3 months compared to only 30% of the control (a significant difference favouring intervention) Differences between the groups declined between 6 to 12 months, with most participants achieving continence in 1 year
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Block randomisation, block size of 4 for 2 groups (A and B) with only one permutation code (ABBA)
Allocation concealment (selection bias)	Unclear risk	Not stated. Therefore judged to be unclear risk
Blinding of participants (performance bias)	High risk	Blinding to intervention not possible
Blinding of personnel (performance bias)	High risk	Blinding to intervention not possible
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No description of blinding of pad test or data entry from questionnaires
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	2 dropped out of control group but none from intervention
Selective reporting (reporting bias)	Unclear risk	Protocol not available
Financial support	Unclear risk	Not reported. Therefore judged to be unclear risk
Approved by medical ethics committee	Low risk	"Approved by the Ethics Committee of our Institution"
Informed consent	Low risk	"All patients signed an informed consent form"
ITT analysis	Unclear risk	Not specified