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

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
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)
  • Number of all participants randomly assigned: 57

  • Age (years): 67.7 ± 8.7

  • Prostate volume (mL): 64.7 ± 19.7

  • PSA (ng/mL): 3.7 ± 2.0

  • IPSS: 22.8 ± 5.9

  • Qmax (mL/s): 7.8 ± 2.5


Group B (TURP)
  • Number of all participants randomly assigned: 57

  • Age (years): 66.4 ± 7.8

  • Prostate volume (mL): 63.5 ± 18.6

  • PSA (ng/mL): 3.6 ± 1.9

  • IPSS: 23.1 ± 5.8

  • Qmax (mL/s): 7.3 ± 2.3

Interventions Group A: PAE
Group B: bipolar TURP
Follow‐up: 24 months
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:
  • Retreatment

  • Erectile function

  • Ejaculatory function

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) 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.