McCullough 2010.
Methods |
Study design: parallel, open‐label, randomised‐controlled trial Setting/country: USA Dates when study was conducted: NR |
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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
Group B
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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 |
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Outcomes |
Primary outcomes
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 |
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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 |
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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 |