Carnevale 2016.
Study characteristics | ||
Methods |
Study design: prospective, randomized, controlled study Study dates: November 2010 to December 2012 Setting: single center, national, outpatient/inpatient Country: Brazil |
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Participants |
Inclusion criteria: men aged > 45 years; IPSS > 19; symptoms refractory to medical treatment for at least 6 months; negative screening for prostate cancer; prostate volume between 30 and 90 mL on magnetic resonance imaging; and bladder outlet obstruction confirmed by urodynamic examination. Exclusion criteria: men with renal failure, bladder calculi or diverticula, suspected prostate cancer, urethral stenosis, or neurogenic bladder disorders. Total number of participants randomly assigned:30 Group A (PAE)
Group B (TURP)
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Interventions |
Group A: PAE Group B: monopolar TURP Follow‐up: 12 months |
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Outcomes |
Urologic symptom scores How measured: IPSS Time points measured: baseline and 1 year Time points reported: baseline and 1 year Subgroups: none Quality of life How measured: IPSS QoL Time points measured: baseline and 1 year Time points reported: baseline and 1 year Subgroups: none Erectile function How measured: IIEF‐5 Time points measured: baseline and 1 year Time points reported: baseline and 1 year Subgroups: none Retreatment How measured: Number of participants that received TURP Time points measured: baseline and 1 year Time points reported: baseline and 1 year Subgroups: none Minor and major adverse event (including ejaculatory function) How measured: National Cancer Institute Common Toxicity Criteria for Adverse Events, version 4.0 Time points measured: not reported Time points reported: not reported Subgroups: none Relevant outcomes not reported in this study:
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Funding sources | No financial disclosure | |
Declarations of interest | None | |
Notes |
Protocol: not available Language of publication: English |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Judgement: not described. |
Allocation concealment (selection bias) | Unclear risk | Judgement: not described. |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Judgement: not described; blinding highly unlikely to have taken place. |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Judgement: not described; blinding highly unlikely to have taken place. |
Blinding of outcome assessment (detection bias) Objective outcomes | Low risk | Judgement: objective outcomes are likely not affected by lack of blinding. |
Incomplete outcome data (attrition bias) Urologic symptom scores/Quality of life | Low risk | Judgement: all randomized participants were included in the analysis (short term). |
Incomplete outcome data (attrition bias) Major adverse events/minor adverse events | Low risk | Judgement: all randomized participants were included in the analysis (short term). |
Incomplete outcome data (attrition bias) Retreatment | Low risk | Judgement: all randomized participants were included in the analysis (short term). |
Incomplete outcome data (attrition bias) Erectile function | Low risk | Judgement: all randomized participants were included in the analysis (short term). |
Incomplete outcome data (attrition bias) Ejaculatory function | Low risk | Judgement: all randomized participants were included in the analysis (short term). |
Selective reporting (reporting bias) | Unclear risk | Judgement: study outcomes were well pre‐defined and described, but protocol was not found. |
Other bias | Low risk | Judgement: statistical differences in baseline IIEF and Qmax, but those likely underestimates the effect size of PAE (more conservative). |