Laurienzo 2013.

Methods	RCT
Participants	Time of recruitment: pre‐operative Population: men having a radical prostatectomy (whole population, with or without UI) Included: patients with prostate cancer (stage T2) and candidates for RPP who were referred for treatment Excluded: radiotherapy (previous or after RPP), previous transurethral resection, pre‐existing neurological disease, urinary fistula after RPP, prolonged indwelling urethral catheterization (more than 15 days), clinical situations that rendered the patient unsuitable for surgical procedure, failure to attend all PFMR or electrical stimulation sessions, loss of follow‐up and desistance   Age (mean, SD): A 64 (8); B 62 (7); C 60 (8) Dropouts: 9 (2 failed to attend all sessions, 2 desistance, 1 adjuvant radiotherapy, 1 postoperative urethral stenosis, 1 urinary fistula, 1 unsuitable for surgery due to cardiovascular risk, 1 inadequate follow up) Unclear from which group Baseline characteristics: Comparable at baseline
Interventions	Time of intervention: pre‐operative only A (15): standard treatment with verbal instructions for PFMT B (17): pre‐operative guided PFMT, with 10 physiotherapy sessions: contractions of the pelvic floor muscles for 5 seconds in “dorsal decubitus” position for 10 times, in the same position with the waist elevated (10 times), lying down with legs adducted against a plastic ball performed 10 times and standing and flexing the hips to 60̊ (10 times)  C (17): pre‐operative PFMT + electrical stimulation during 10 physiotherapy sessions, electrical stimulation was with an anal probe lasting 15 minutes in total, and men also received guided PFMT and followed the same training regime as above Men did not receive PFMT post‐operatively   Duration of treatment: 10 pre‐operative sessions  Follow up: 1, 3 and 6 months
Outcomes	Primary outcome (number of men with UI) Not reported Other outcomes 1 hour pad test score (mean (SD) N) 1 month: A 17.6 (38.5) 15; B 29.5 (35.8) 17; C 25.5 (35.4) 17 3 months:14.3 (34.4) 15; B 11.8 (28.4) 17; C 9.6 (18.8) 17 6 months: A 5.5 (14.16) 15; B 25.3 (59) 17; 4.35 (7.3) 17 Quality of life ICIQ‐SF score (mean (SD) N) 1 month: A 7.5 (5) 15; B 14 (3.6) 17; C 9.6 (6.3) 17 3 months: A 5.4 (5.2) 15; B 6.9 (5.8) 17; C 7.2 (6.4) 17 6 months: A 3.7 (5.3) 15; B 4.8 (5.3) 17; C 5.3 (5.5) 17 SF‐36 Results not reported: “There were no differences between groups on the various domains of the SF‐36 (p > 0.05)”
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“The patients were randomized (computer generated list using Randomizer, v4)”
Allocation concealment (selection bias)	Unclear risk	“The patients were randomized (computer generated list using Randomizer, v4)”
Blinding of participants (performance bias)	High risk	Blinding to intervention not possible
Blinding of personnel (performance bias)	Unclear risk	“PFMR was performed in the preoperative period by the same physiotherapist.”
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information. Therefore judged to be unclear risk
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	9 (2 failed to attend all sessions, 2 desistance, 1 adjuvant radiotherapy, 1 post‐operative urethral stenosis, 1 urinary fistula, 1 unsuitable for surgery due to cardiovascular risk, 1 inadequate follow‐up). Unclear from which group
Selective reporting (reporting bias)	High risk	Results of SF‐36 not reported
Financial support	Low risk	“Sao Paulo State Foundation for Research Support – FAPESP (number 08/54585‐1)”
Approved by medical ethics committee	Low risk	“After approval by the ethical committee and internal review board, 58 consecutive males were included in this analysis”
Informed consent	Low risk	“All subjects received and signed an informed consent form”
ITT analysis	Low risk	Data presented for all men randomised and not excluded. No differential dropout apparent