Tienforti 2012.

Methods	RCT
Participants	Time of recruitment: pre‐operative Population: men undergoing radical prostatectomy (whole population, with or without UI) Included: men who underwent open retropubic radical prostatectomy for clinically localized prostate cancer (cT1a to cT2b), able to regularly attend an ambulatory schedule Excluded: prior diseases with a possible impact on urinary continence, preoperative radiotherapy and any medical condition that could limit participation in the training programme Age (mean, range): A 67 (60 to 74); B 64 (52 to 74) Dropouts: 1 from A (intolerance to procedure using rectal probe), 1 from B (surgical complication) Not differential dropout Baseline characteristics: comparable at baseline
Interventions	Time of intervention: pre‐operative A (16): on the day before RP + the day after catheter removal, patients received guided PFMT + biofeedback + information about the anatomy of pelvic floor muscles and wrong execution was corrected, also given oral and written instructions on Kegel exercises to be performed at home, instructed to: perform three sets daily for 10 mins, each contraction lasting 5 seconds with 5 seconds of relaxation, contract their pelvic floor while lying, sitting and standing, frequency recorded in training diary, After RP visits at monthly intervals after catheter removal involving assisted biofeedback and motivation for 20 min B (16): after catheter removal, men received standard care, oral and written instructions from urologist on PFMT, Instructed to: start PFMT (e.g. 2 to 3 weeks after surgery), control visits at 3 + 6 months after catheter removal   All men were given oral and written instructions post‐operatively to perform PFMT at home, 3 sets daily of 10 min each Duration of treatment: monthly visits as long as patient required pads, including safety pads Follow up: at least 6 months after catheter removal
Outcomes	Primary outcome (number of men with UI) Number of incontinent men (defined as ICIQ‐UI > 0) 1 month: A 10/16; B 16/16, P = 0.02 3 months: A 8/16; B 15/16, P = 0.01 6 months: A 6/16; B 15/16, P = 0.002 Other outcomes Number of continent men (efined as ICIQ‐UI = 0) 1 month: A 6/16; B 0/16, P = 0.02 3 months: A 8/16; B 1/16, P = 0.01 6 months : A 10/16; B 1/16, P = 0.002   Mean number of incontinence episodes per week/24 hours (mean (SD) N) 1 month: A 1.43 (0.82) 16; B 14 (0.82) 16, P = N.S 3 months: A 0.57 (1.47) 16; B 2 (1.47) 16, P = 0.01 6 months: A 0.43 (1.33) 16; B 1.86 (1.33) 16, P = 0.005   Mean number of pads used per week/24 hours (mean (SD) N) 1 month: A 0.46 (0.67) 16; B 0.94 (0.67) 16 P = NS 3 months: A 0.23 (0.63) 16; B 0.91 (0.63) 16 P = 0.005 6 months: A 0.2 (0.57) 16; B 0.66 (0.57) 16 P = 0.03   Quality of life Mean ICIQ‐OAB score (mean (SD) N) 1 month: A 11.5 (3.6) 16; B 14 (3.6) 16, P = NS 3 months: A 11 (0.92) 16; B 11.7 (0.92) 16, P = 0.04 6 months: A 9 (4.1) 16; B 13 (4.1) 16, P = 0.01   Mean UCLA‐PCI score (mean (SD) N) 1 month: A 330 (?) 16; B 260 (?) 16, P = NS 3 months: A 400 (500) 16; B 270 (338) 16, P = 0.006 6 months: A 430 (487) 26; B 275 (311) 16, P = 0.003
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Generated by computer and was stratified with a 1:1 allocation”
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of participants (performance bias)	High risk	“Participants were unblinded to treatment assignment”
Blinding of personnel (performance bias)	Low risk	“Surgeons and person scoring the evaluation questionnaires were blinded throughout the duration of the study”
Blinding of outcome assessment (detection bias) All outcomes	Low risk	“nurse scoring the evaluation questionnaires was blinded” to randomisation
Incomplete outcome data (attrition bias) All outcomes	Low risk	1 from A (intolerance to procedure) 1 from B (surgical complication). Not differential dropout
Selective reporting (reporting bias)	Unclear risk	Protocol not available
Financial support	Unclear risk	Not reported
Approved by medical ethics committee	Low risk	“Work was carried out in accordance with the ethical standards of the appropriate institutional committee on human experimentation and with the last revision of the Helsinki Declaration
Informed consent	Low risk	“All eligible patients gave informed signed consent”
ITT analysis	Low risk	Assumed from patient flow diagram