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 |
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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)
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 |
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
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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 | 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. |