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

Radwan 2020.

Study characteristics
Methods Study design: parallel randomized controlled study
Dates when study was conducted: January 2016 to January 2018
Setting: single center/national
Country: Egypt
Participants Inclusion criteria:men complained of LUTS with an IPSS score of 8 to 35 (8 being moderate and 35 being severe), uroflowmetry with an average flow ≤ 10 mL/s, and a prostate volume less than 100 mL by TRUS
Exclusion criteria: men with elevated kidney functions (1.5 mg/dL), with allergy to intravenous contrast media, unfit for surgery, with prostatic adenocarcinoma, with previous history of prostatic or urethral operations, with signs of the decompensated bladder (e.g., bladder diverticulum), with signs of upper urinary tract infection revealed by pelvic abdominal ultrasound were excluded
Total number of participants randomly assigned: 60
Group A (PAE)
  • Number of all participants randomly assigned: 20

  • Age (years): 63.0 ± 7.2

  • Prostate volume (mL): 58.7 ± 23.4

  • PSA (ng/mL): not reported

  • IPSS: 27.0 ± 5.0

  • Qmax (mL/s): 9.2 ± 4.8


Group B (TURP)
  • Number of all participants randomly assigned: 40

  • Age (years): 62.0 ± 9.0

  • Prostate volume (mL): 60.1 ± 21.5

  • PSA (ng/mL): not reported

  • IPSS: 26.5 ± 4.0

  • Qmax (mL/s): 8.3 ± 5.7

Interventions Group A: PAE
Group B: TURP (monopolar or bipolar)
Follow‐up: 6 months
Outcomes Urologic symptom scores
How measured: IPSS
Time points measured: baseline, 1 and 6 months
Time points reported: baseline, 1 and 6 months
Subgroups: none
Retreatment
How measured: participants with a surgical procedure at follow‐up
Time of measurement: NR but likely for follow‐up period
Time of reporting: likely cumulative incidence
Major and minor adverse events (including acute urinary retention)
How measured:Clavien‐Dindo classification
Time points measured: at baseline, 1, 3, and 6 months
Time points reported: likely cumulative incidence
Subgroup: none
Relevant outcomes not reported in this study
  • Quality of life

  • Erectile function

  • Ejaculatory function

  • Indwelling urinary catheter (pre‐specified for each group)

Funding sources Not reported
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 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.
Incomplete outcome data (attrition bias)
Major adverse events/minor adverse events Unclear risk Judgement: all randomized participants were included in the analysis.
Incomplete outcome data (attrition bias)
Retreatment Low risk Judgement: all randomized participants were included in the analysis.
Incomplete outcome data (attrition bias)
Acute urinary retention Low risk Judgement: all randomized participants were included in the analysis.
Incomplete outcome data (attrition bias)
Indwelling catheter Unclear risk Judgement: all randomized participants were included in the analysis (catheter removal time: TURP [third postoperative day], PAE [fifth postoperative day]).
Selective reporting (reporting bias) Unclear risk Judgement: protocol was not found, the outcomes at prespecified time point (likely 1 month) were omitted.
Other bias Low risk Judgement: not detected.