Summary of findings for the main comparison. Aquablation compared to transurethral resection of the prostate for benign prostatic hyperplasia.
Patient or population: men with benign prostatic hyperplasia (BPH) Setting: multicenter (17 centres)/ multicountry (Australia 1, New Zealand 1, UK 3, USA 12) Intervention: Aquablation Comparison: transurethral resection of the prostate (TURP) | |||||
Outcomes | № of participants (studies) | Certainty of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | |
Risk with TURP | Risk difference with Aquablation | ||||
Urologic symptom scores Assessed with: IPSS Scale from 0 (best: not at all) to 35 (worst: almost always) Follow‐up: 12 months | 174 (1 RCT) | ⊕⊕⊕⊝ Moderatea | ‐ | The mean urologic symptom score was −15.12 | MD 0.06 lower (2.51 lower to 2.39 higher) |
Quality of life Assessed with: IPSS‐QoL Scale from 0 (best: delighted) to 6 (worst: terrible) Follow‐up: 12 months | 174 (1 RCT) | ⊕⊕⊝⊝ Lowa,b | ‐ | The mean quality of Life was −3.45 | MD 0.27 higher (0.24 lower to 0.78 higher) |
Major adverse events Assessed with: Clavien‐Dindo classification system (Grade III, IV and V complications) Follow‐up: 12 months | 181 (1 RCT) | ⊕⊝⊝⊝ Very lowa,c | RR 0.84 (0.31 to 2.26) | Study population | |
92 per 1000d | 15 fewer per 1000 (64 fewer to 116 more) | ||||
Retreatment Follow‐up: 12 months | 181 (1 RCT) | ⊕⊝⊝⊝ Very lowa,c | RR 1.68 (0.18 to 15.83) | Study population | |
15 per 1000d | 10 more per 1000 (13 fewer to 228 more) | ||||
Erectile function (sexually active men only) Assessed with: IIEF‐EF domain Scale from 1 (worst; severe erectile dysfunction) to 30 (best; no erectile dysfunction) Follow‐up: 12 months | 64 (1 RCT) | ⊕⊝⊝⊝ Very lowb,e | ‐ | The mean erectile function (sexually active men only) was −2.73 | MD 2.31 higher (0.63 lower to 5.25 higher) |
Ejaculatory function (sexually active men only) Assessed with: MSHQ‐EjD Scale from 1 (worst) to 15 (best) Follow‐up: 12 months | 121 (1 RCT) | ⊕⊝⊝⊝ Very lowb,e | ‐ | The mean ejaculatory function (sexually active men only) was −2.642 | MD 2.57 higher (0.6 higher to 4.53 higher) |
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). BPH: benign prostate hyperplasia; CI: confidence interval; EF: erectile function; IIEF: International index of erectile function; IPSS: International prostate symptom score; MD: mean difference; MSHQ‐EjD: Male Sexual Health Questionnaire for Ejaculatory Dysfunction; RCT: randomised controlled trial; RR: risk ratio; TURP: transurethral resection of prostate; QoL: quality of life | |||||
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. |
aDowngraded by one level for study limitations: high risk of performance and unclear risk of reporting bias. bDowngraded by one level for imprecision: confidence interval crosses assumed threshold of minimal clinically important difference. cDowngraded by two levels for imprecision: wide confidence interval crosses assumed threshold of minimal clinically important difference. dControl group risk estimates come from single estimates of included study control group. Relative effect based on available case analysis. eDowngraded by two levels for study limitations: high risk of performance and attrition bias.