Fode 2014.

Methods	RCT
Participants	Time of recruitment: pre‐operative Population: 83 men undergoing nerve sparing radical prostatectomy (whole population, with or without UI) Included: sexually active men with an IIEF score of at least 18 without aids, continent pre‐operatively Excluded: condition that may prevent patient being able to have post‐operative treatment with PDE5‐inhibitor Age (mean, range): A 62 (46‐73); B 65 (49 to 76) Dropouts: 12 from group A (3 excluded because underwent non‐nerve sparing surgery, 2 withdrew consent, 1 lost a partner, 6 non‐compliance), 3 from group B (2 excluded because underwent non‐nerve sparing surgery, 1 withdrew consent). Differential dropout Baseline characteristics: comparable except Group A significantly more LUTS pre‐operatively
Interventions	Time of intervention: pre‐operative + post‐operative A (30): pre‐operative session guided PFMT + instruction on how to use penile vibratory stimulation device, instructed to stimulate frenulum once daily, 10 seconds of stimulation then 10 second pause, repeated 10 times for 1 week pre‐operatively, Instructed to restart stimulation after catheter removal for 6 weeks B (38): pre‐operative session guided PFMT  All men were offered a PDE5 inhibitor after 1 month post‐operatively and also received telephone contact to ensure compliance with treatment  Duration of treatment:  6 weeks Follow up: 3, 6 and 12 months post‐operatively
Outcomes	Primary outcome (number of men with UI) Number of incontinent men (men reporting use of more than one pad daily) 3 months: A 14/42; B 15/41 6 months: A 7/42; B 3/41 12 months: A 3/30; B 2/38 (dropout figures added to 3 and 6 months)  Other outcomes Continence rate (patients reporting use of up to one pad daily for security reasons only) 3 months: A 65.5%; B 62.9%, P = 0.83 6 months : A 83.3%; B 91.9%, P = 0.28 12 months : A 90%; B 94.7%, P = 0.46 Median (range) pad use 3 months: A 1 (0 to 6); B 5 (0 to ‐34), P = 0.09 6 months: A 0 (0 to 3); B 1/3 (0 to 6), P = 0.14 12 months: A 0 (0 to 2); B 0 (0 to 3),  P = 0.56 Median (range) IIEF‐5 3 months : A 5 (0 to 25); B 5 (0‐25), P = 0.25 6 months : A 10.5 (0 to 25); B 5 (0‐25), P = 0.08 12 months : 18 (0 to 25); B 7.5 (0‐25), P = 0.09 IIEF ≥ 18, n/N (%) 3 months: 5/30 (17); B 4/38 (11), P = 0.46 6 months: 13/30 (43); B 9/38 (24), P = 0.09 12 months: 16/30 (53); B 12/38 (32), P = 0.07 Adverse effects: A: 5/30 reported side effects as a result of penile vibratory stimulation (1 red spots on glans penis, 1 small laceration + some bleeding, 2 complained of soreness, 1 frank pain post‐operatively) B: 0/38 Quality of life Median (range) DAN‐PSS post‐operatively 3 months: A 1 (0 to 34); B 5 (0‐34), P = 0.74 6 months: A 2 (0 to 41); B 1 (0‐48), P = 0.74 12 months: A 3 (0 to 36); B 0.5 (0‐21), P = 0.13
Notes	Further information provided by authors PDE5 (phosphodiesterase yype 5) inhibitor is used for erectile dysfunction
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"randomized prospective trial" and “randomized by a draw”
Allocation concealment (selection bias)	Low risk	Used opaque sealed envelopes
Blinding of participants (performance bias)	High risk	“It was not possible to create a believable sham device, which could maintain blinding of the study subjects”
Blinding of personnel (performance bias)	Unclear risk	Not reported. Therefore judged to be unclear risk
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcome assessor not blinded
Incomplete outcome data (attrition bias) All outcomes	High risk	12 from group A (3 excluded because underwent non‐nerve sparing surgery, 2 withdrew consent, 1 lost a partner, 6 non‐compliance), 3 from group B (2 excluded because underwent non‐nerve sparing surgery, 1 withdrew consent). Differential dropout
Selective reporting (reporting bias)	Low risk	Outcomes in methods reported
Financial support	Low risk	“This study was funded by unrestricted grants from the Velux Foundation and Grosserer L.F. Foghts Foundation”
Approved by medical ethics committee	Low risk	“The study was approved by the Danish ethical counsel and the Danish Data protection Agency”
Informed consent	Low risk	Assumed as they acquired ethical approval
ITT analysis	Low risk	Assumed from patient flow diagram