Zhu 2018.
Study characteristics | ||
Methods |
Study design: parallel randomized controlled study Dates when study was conducted: January to October 2016 Setting: single center Country:China |
|
Participants |
Inclusion criteria:men with:
Exclusion criteria: men with:
Total number of participants randomly assigned: 40 Group A (PAE)
Group B (Sham)
|
|
Interventions |
Group A: PAE Group B: TURP (not defined) Follow‐up: 12 months |
|
Outcomes |
Urologic symptom scores How measured: IPSS Time points measured: at baseline, 3, 6, and 12 months Time points reported: at baseline, 3, 6, and 12 months Subgroups: none Quality of Life How measured: IPSS‐QoL Time points measured: at baseline, 3, 6, and 12 months Time points reported: at baseline, 3, 6, and 12 months Subgroups: none Acute urinary retention How measured: not reported Time points measured: within 12 months Time points reported: likely cumulative incidence. Subgroups: none Relevant outcomes not reported in this study
|
|
Funding sources | Not available | |
Declarations of interest | Not available | |
Notes |
Protocol: not available Language of publication: Chinese |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Judgement: random number table method. |
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 | Low risk | Judgement: all randomized participants were included in the analysis (short term). |
Incomplete outcome data (attrition bias) Acute urinary retention | Low risk | Judgement: all randomized participants were included in the analysis (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. |
BPH: benign prostatic hyperplasia; ICS male IS‐SF: International Continence Society short‐form male questionnaire; IIEF‐15: International index of erectile function; IPSS: International Prostate Symptom Score; MSHQ‐EJD; Male sexual health questionnaire for ejaculatory dysfunction; NA: not available; NR: not reported; OAB‐q SF: Overactive bladder questionnaire short form; PGI‐I: Patient Global Impression of Improvement; PSA: prostate specific antigen; PUL: prostatic urethral lift; PVR: post‐void residual volume; Qmax: maximum flow rate; QoL: quality of life; SD: standard deviation; SF‐6D: Short‐Form Six‐Dimension; SF‐12: 12‐item Short‐Form Health Survey; TURP: transurethral resection of prostate; VAS: visual analogue scale.