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 |
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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)
Group B (TURP)
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Interventions |
Group A: PAE Group B: TURP (monopolar or bipolar) Follow‐up: 6 months |
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Outcomes |
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
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 |
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Funding sources | Not reported | |
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 | 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. |