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. 2021 Jul 15;2021(7):CD013656. doi: 10.1002/14651858.CD013656.pub2

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
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)
  • Number of all participants randomly assigned: 15

  • Age (years): 63.5 ± 8.7

  • Prostate volume (mL): 63.0 ± 17.8

  • PSA (ng/mL): 3.4 ± 2.2

  • IPSS: 25.3 ± 3.6

  • Qmax (mL/s): 7.0 ± 3.6


Group B (TURP)
  • Number of all participants randomly assigned: 15

  • Age (years): 66.4 ± 5.6

  • Prostate volume (mL): 56.6 ± 21.5

  • PSA (ng/mL): 3.2 ± 2.5

  • IPSS: 27.6 ± 3.2

  • Qmax (mL/s): 9.7 ± 3.8

Interventions Group A: PAE
Group B: monopolar TURP
Follow‐up: 12 months
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:
  • Indwelling urinary catheter (beyond 1 case due to hematuria)

  • Acute urinary retention

Funding sources No financial disclosure
Declarations of interest None
Notes Protocol: not available
Language of publication: English
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).