Dijkstra‐Eshuis 2013.

Methods	RCT
Participants	Time of recruitment: pre‐operative Population: men having a laparoscopic radical prostatectomy (whole population, with or without UI) Included: patients with prostate cancer, undergoing laparoscopic radical prostatectomy Excluded:  neurological disorders, a medical history with invasive perineal and/or rectal surgery, preoperatively existing stress urinary incontinence, radiation, ≥ 75 years Age (mean, SD): A 63.7 (5.3); B 63.7 (5.3) Dropouts: 9 from A (1 unable to understand Dutch, 3 post‐operative radiotherapy, 1 oesophageal cancer, 3 discontinued intervention at own request, 1 excluded due to poor compliance) 8 from B (2 post operative radiotherapy, 1 pelvic lymph node dissection, 1 died of cause unrelated to prostate cancer, 5 discontinued intervention at own request, 1 prolonged catheter) Not differential dropout Baseline characteristics:  comparable at baseline
Interventions	Time of intervention: pre‐operative (+ postoperative treatment for all men) A (56): 30 mins of guided PFMT + biofeedback weekly for 4 weeks before surgery, received written instructions to: carry out two sets of 30 contractions during abdominal breathing, one breath between each contraction; restart PFMT after catheter removal (7 to 10 days after surgery) B (46): received written instructions on PFMT after catheter removal (7 to 10 days after surgery) All men were seen before surgery by a physiotherapist, who explained relevant anatomy, anal visual inspection and digital palpation, biofeedback registration with rectal probe All patients received PFMT + biofeedback and/or electrical stimulation if still incontinent after 6 weeks Duration of treatment Follow up: 6 weeks, 3 months, 6 months, 9 months and 12 months after surgery
Outcomes	Primary outcome (number of men with UI) Number of incontinent men (leakage on 24 hour pad test) 12 months: A 20/58; B 9/45 Other outcomes Number of continent men after 1 year (no leakage at all on 24 hour pad test) 12 months: 38/58; B 36/45 Adverse effects: A 0/56; B 0/46 Quality of life King’s Health Questionnaire (KHQ) (mean (SD) N): General health 12 months: A 24.48 (50.7) 56; B 29.64 (50.7) 46 Role limitations 12 months: A 21.36 (22.2) 56; B 17.73 (22.2) 46 Physical limitations 12 months: A 16.49 (15.45) 56; B 13.48 (15.45) 46 Social limitations 12 months: A 7.98 (24.8) 56; B 4.15 (24.8) 46 Personal 12 months: A 18.72 (4.4) 56; B 19.62 (4.4) 46 Emotional 12 months: A 5.08 (7.0) 56; B 4.24 (7.0) 46 Sleep or energy disturbance: A 9.13 (39.0) 56; B 6.13 (39.0) 46 Symptom severity: A 14.62 (86.1) 56; B 10.93 (86.1) 46
Notes	Trial was stopped early because interim analysis found no benefit for group A Additional information supplied by author
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Computer‐generated random numbers with block randomization and variable block size”
Allocation concealment (selection bias)	Low risk	"central computer system"
Blinding of participants (performance bias)	Unclear risk	“participants were also blinded until their first visit to the pelvic floor physiotherapist”
Blinding of personnel (performance bias)	Low risk	“The pelvic floor physiotherapists were blinded to randomization” (to pre‐operative randomisation)
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Outcome assessor blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	9 from A (1 unable to understand Dutch, 3 post‐operative radiotherapy, 1 oesophageal cancer, 3 discontinued intervention at own request, 1 excluded due to poor compliance) 8 from B (2 post‐operative radiotherapy, 1 pelvic lymph node dissection, 1 died of cause unrelated to prostate cancer, 5 discontinued intervention at own request, 1 prolonged catheter á demeure). Not differential dropout
Selective reporting (reporting bias)	Low risk	All outcomes in methods were reported
Financial support	Low risk	None
Approved by medical ethics committee	Low risk	“Medical ethical approval was obtained from the Medical Ethics committee of our university hospital”
Informed consent	Low risk	“Informed consent was obtained”
ITT analysis	Low risk	Assumed from flow diagram