Pace 2010.

Methods	Study design: RCT Setting/country: Italy Dates when study was conducted: 2005–2009
Participants	Inclusion criteria: men with total PSA 510 ng/mL, Gleason score ≤ 7 on biopsy, no capsular involvement, normal preoperative EF assessed by an IIEF score ≥ 26, without the use of any therapy for improving erection Exclusion criteria: men with cardiovascular diseases and previous pharmacological treatments which did not allow the contemporary use of PDE5I Total number of participants randomly assigned: 40 Group A Number of participants randomly assigned: 20 Age: NR Mean PSA (ng/mL): 5.5 (range 1.2–9.9) Gleason score (pathological): 6: 18 (90.0%)/ 7: 2 (10.0%) Tumour stage (pathological): T1b and T1c: 10 (50.0%), T2a: 9 (45.0%), T2b: 1 (5.0%) IIEF‐5: NR Mean IIEF‐EF: 26.2 Group B Number of participants randomly assigned: 20 Age (years): NR PSA (ng/mL): 6 (range 1.8–8.9) Gleason score (pathological): 6: 18 (90.0%)/ 7: 2 (10.0%) Tumour stage (pathological): T1b and T1c: 9 (45.0%), T2a: 9 (45.0%), T2b: 2 (10.0%) IIEF‐5: NR Mean IIEF‐EF: 26.5
Interventions	Group A: sildenafil 50 mg or 100 mg at night Group B: no treatment Surgery or cointervention: BNSRRP Interval between surgery and intervention: 2 weeks Intervention duration: 8 weeks Washout period before outcome assessment: 14 weeks Total follow‐up period: 24 weeks
Outcomes	Primary outcomes IIEF; potency rates; percentage of men who were capable of having medication‐unassisted intercourse; percentage of men with normal EF domain; satisfaction rate How measured: NR (maybe IIEF‐EF); NR; NR; IIEF‐EF; NR Time points measured: before surgery and then at 3, 6, 12 and 24 weeks after NSRP; NR; NR; before surgery and then at 3, 6, 12 and 24 weeks after NSRP; NR Time points reported: before surgery and then at 3, 6, 12 and 24 weeks after NSRP; before and at 24 weeks; before and at 24 weeks; before and at 24 weeks; before and at 24 weeks Secondary outcomes Rates of treatment discontinuation How measured: NR Time points measured: 8 weeks Time points reported: 8 weeks Safety outcomes How measured: adverse events Time points measured: NR Time points reported: NR Subgroup: none
Funding sources	NR
Declarations of interest	NR
Notes	Protocol: NA Language of publication: English
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not described
Blinding of outcome assessment (detection bias) Subjective outcomes	Unclear risk	Not described
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Objective outcome not likely affected by lack of blinding.
Incomplete outcome data (attrition bias) Self‐reported potency	Unclear risk	Not available
Incomplete outcome data (attrition bias) EF/IIEF	Unclear risk	Not available
Incomplete outcome data (attrition bias) Serious adverse event	Low risk	All participants were included in the analysis.
Incomplete outcome data (attrition bias) Sexual quality of life	Unclear risk	No information given
Incomplete outcome data (attrition bias) Treatment discontinuation	Low risk	All participants were included in the analysis.
Incomplete outcome data (attrition bias) Acceptability of the intervention	Unclear risk	No information given
Selective reporting (reporting bias)	Unclear risk	Predefined outcomes well described but protocol was not available.
Other bias	Low risk	Not detected