Gao 2014.
Study characteristics | ||
Methods |
Study design: prospective, parallel randomized controlled study Dates when study was conducted: January 2007 to January 2012 Setting: not defined Country: China |
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Participants |
Inclusion criteria: men with IPSS greater than 7 after failed medical therapy with a washout period of 2 or more weeks, prostate volume of 20 ‐100 mL on transrectal ultrasonographic or magnetic resonance imaging, Qmax of less than 15 mL/sec, and negative prostate biopsy if PSA > 4 ng/mL or abnormal digital rectal examination. Exclusion criteria: men with detrusor hyperactivity or hypocontractility at urodynamic study, urethral stricture, prostate cancer, diabetes mellitus, and previous prostate, bladder neck, urethral surgery, or positive prostate biopsy. Total number of participants randomly assigned: 114 Group A (PAE)
Group B (TURP)
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Interventions |
Group A: PAE Group B: bipolar TURP Follow‐up: 24 months |
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Outcomes |
Urologic symptoms score How measured: IPSS score Time points measured: at baseline, 1 month, 3 months, 6 months, 1 year, and 2 years Time points reported: at baseline, 1 month, 3 months, 6 months, 1 year, and 2 years Subgroups: none Quality of life How measured: IPSS QoL Time points measured: at baseline, 1 month, 3 months, 6 months, 1 year, and 2 years Time points reported: at baseline, 1 month, 3 months, 6 months, 1 year, and 2 years Subgroups: none Acute urinary retention/Indwelling urinary catheter How measured: Narratively Time points measured: not reported Time points reported: early (< 30 days), late (≤ 2 years) Subgroups: none Major and minor adverse events How measured: modified Clavien Classification system Time points measured: not reported Time points reported: early (< 30 days), late (≤ 2 years) Subgroups: 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) | Low risk | Quote: “computer‐generated simple random tables.” |
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 | Unclear risk | Judgement: 47/57 (82.5%) and 48/57 (84.3%) randomized participants in PAE and TURP were included in the analysis, respectively (short and long term). |
Incomplete outcome data (attrition bias) Major adverse events/minor adverse events | Low risk | Judgement: 54/57 (94.8%) and 53/57 (93.0%) randomized participants in PAE and TURP were included in the analysis, respectively (short and long 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) Acute urinary retention | Low risk | Judgement: 54/57 (94.8%) and 53/57 (93.0%) randomized participants in PAE and TURP were included in the analysis, respectively (long term). |
Incomplete outcome data (attrition bias) Indwelling catheter | Low risk | Judgement: 54/57 (94.8%) and 53/57 (93.0%) randomized participants in PAE and TURP were included in the analysis, respectively (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: not detected. |