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. 2018 Oct 23;2018(10):CD012414. doi: 10.1002/14651858.CD012414.pub2

McCullough 2010.

Methods Study design: parallel, open‐label, randomised‐controlled trial
Setting/country: USA
Dates when study was conducted: NR
Participants Inclusion criteria: men < 70 years, sexually active in a stable relationship, with normal EF as determined by the IIEF‐EF domain score (IIEF‐EF score ≥ 26 was required to be eligible for study) and scheduled to undergo BNSRP.
Exclusion criteria: men with Gleason score > 7, PSA > 20 ng/mL and postoperative radiation therapy or androgen ablation
Total number of participants randomly assigned: 212
Group A
  • Number of participants randomly assigned: 73

  • Mean age (years): 55.6 (SD 5.9)

  • PSA: NR

  • Gleason score (pathological): NR

  • Tumour stage (pathological): NR

  • IIEF‐5: NR

  • IIEF‐EF: NR


Group B
  • Number of participants randomly assigned: 139

  • Mean age (years): 56.8 (SD 6.4)

  • PSA: NR

  • Gleason score (pathological): NR

  • Tumour stage (pathological): NR

  • IIEF‐5: NR

  • IIEF‐EF: NR

Interventions Group A: nightly SC 50 mg
Group B: intraurethral alprostadil 125 μg daily/at 2 month after surgery dose titration 250 μg
Surgery or cointervention: BNSRP
Interval between surgery and intervention: 1 month
Intervention duration: 8 months
Washout period before outcome assessment: 1 month
Total follow‐up period: 11 months
Outcomes Primary outcomes
  • EDITS; IIEF; GAQ "Has the treatment you have been taking improved you erection?," SEP, SPL, adverse events


How measured: EDITS; IIEF‐EF; GAQ/SPL (SPL): measured from pubic bone to coronal sulcus with a rigid ruler, adverse events as reported in study
Time points measured: EDITS: 11 months; other outcomes: 1, 9 and 11 months
Time points reported: EDITS: 11 months; other outcomes: 1, 9 and 11 months
Secondary outcome: none reported
Safety outcomes: adverse events
How measured: NR
Time point measured: postoperative 1, 9 and 11 months
Time point reported: postoperative 1, 9 and 11 months
Subgroup: none
Funding sources Vivus, Pfizer, Med Reviews, American Medical Systems, Auxilium, Coloplast, Cook, GlaxoSmithKline/Schering Plough, Indevus, Johnson & Johnson, Medtronic, National Institute of Health, Plethora, Sanofi‐Aventis, Solvay, Theralogix, Timm Medical, Augusta Medical, Watson, Aeterna‐Zentaris, Steba‐Pharma, Serenity and USOHIFU
Declarations of interest None reported
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 High risk Quote: "open label study"
Blinding of outcome assessment (detection bias) 
 Subjective outcomes High risk Quote: "open label study"
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 High risk 42/139 (30.2%) participants in experimental group and 14/73 (19.1%) participants in control group not included in the analysis.
Incomplete outcome data (attrition bias) 
 EF/IIEF High risk 42/139 (30.2%) participants in experimental group and 14/73 (19.1%) participants in control group not included in the analysis.
Incomplete outcome data (attrition bias) 
 Serious adverse event Unclear risk No information given
Incomplete outcome data (attrition bias) 
 Sexual quality of life Unclear risk No information given
Incomplete outcome data (attrition bias) 
 Treatment discontinuation Unclear risk No information given
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 not available.
Other bias Low risk Not detected