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. 2020 Dec 23;2020(12):CD012867. doi: 10.1002/14651858.CD012867.pub2

Radwan 2020.

Study characteristics
Methods Study design: parallel randomized controlled study
Setting/Country: single center/Egypt
Dates when study was conducted: January 2016 to January 2018
Participants Inclusion criteria: men with LUTS with an IPSS score 8–35 (8 being moderate and 35 being severe), uroflowmetry with a mean flow ≤ 10 mL/second, and a prostate volume < 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 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 US were excluded
Total number of participants randomly assigned: 60
Group A (PAE)
  • Number of all participants randomly assigned: 20

  • Age (years): 63.0 (SD 7.2)

  • Prostate volume (mL): 58.7 (SD 23.4)

  • PSA (ng/mL): not reported

  • IPSS: 27.0 (SD 5.0)

  • Qmax (mL/second): 9.2 (SD 4.8)


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

  • Age (years): 62.0 (SD 9.0)

  • Prostate volume (mL): 60.1 (SD 21.5)

  • PSA (ng/mL): not reported

  • IPSS: 26.5 (SD 4.0)

  • Qmax (mL/second): 8.3 (SD 5.7)

Interventions Group A: PAE
Group B: TURP (monopolar or bipolar)
Follow‐up: 6 months
Outcomes
  • IPSS


How measured: IPSS questionnaire/uroflowmetry/TRUS/not reported
Time points measured: at baseline, 1 month, and 6 months
Time points reported: at baseline, 1 month, and 6 months
  • Qmax, prostate volume, PVR


How measured: uroflowmetry/TRUS/NR
Time points measured: at baseline, 1 month, and 6 months
Time points reported: at baseline and postoperatively (not defined)
Safety outcomes:
How measured: TUR syndrome, acute urinary retention, postembolization syndrome
Time points measured: not reported
Time points reported: likely cumulative incidence
Subgroup: none
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 Judgment: not described.
Allocation concealment (selection bias) Unclear risk Judgment: not described.
Blinding of participants and personnel (performance bias)
All outcomes High risk Judgment: not described; blinding highly unlikely to have taken place.
Blinding of outcome assessment (detection bias)
Subjective outcomes High risk Judgment: not described; blinding highly unlikely to have taken place.
Blinding of outcome assessment (detection bias)
Objective outcomes Low risk Judgment: objective outcomes likely not affected by lack of blinding.
Incomplete outcome data (attrition bias)
Urologic symptom scores/QoL Low risk Judgment: all randomized participants were included in the analysis.
Incomplete outcome data (attrition bias)
Major/minor adverse events Low risk Judgment: all randomized participants were included in the analysis.
Incomplete outcome data (attrition bias)
Retreatment Low risk Judgment: all randomized participants were included in the analysis.
Incomplete outcome data (attrition bias)
Erectile function Unclear risk Judgment: no information given (not measured).
Incomplete outcome data (attrition bias)
Ejaculatory disorders Unclear risk Judgment: no information given (not measured).
Incomplete outcome data (attrition bias)
Acute urinary retention Low risk Judgment: all randomized participants were included in the analysis.
Incomplete outcome data (attrition bias)
Indwelling urinary catheter Low risk Judgment: all randomized participants were included in the analysis (catheter removal time: TURP [third postoperative day], PAE [fifth postoperative day]).
Incomplete outcome data (attrition bias)
Hospital stay Unclear risk Judgment: no information given (not measured).
Selective reporting (reporting bias) Unclear risk Judgment: protocol was not found, the outcomes at prespecified time point (likely 1 month) were omitted
Other bias Low risk Judgment: not detected.