Summary of findings 2. PAE compared to TURP for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia (long term).
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Participants: men with lower urinary tract symptoms suggesting benign prostatic hyperplasia Setting: RCT (likely single center) and NRS (multicenter registry‐based study)/China and Europe Intervention: PAE Comparator: TURP | ||||||
| Outcomes | No of participants (studies) | Certainty of evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | What happens? | |
| Risk with TURP (long term) | Risk difference with PAE | |||||
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Urologic symptom scores
assessed with International Prostate Symptom Score
Scale from 0 (best; not at all) to 35 (worst; almost always) Follow‐up: 24 months MCID: 3 points |
176 (2 RCTs) | ⊕⊕⊝⊝ Lowa,b,c | — | Urologic symptom scores of RCTs ranged from 5.19 to 8.4 | MD 2.58 higher (1.54 lower to 6.71 higher) | There may be little to no difference in urologic symptom score improvement from PAE compared to TURP. |
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Quality of life
assessed with International Prostate Symptom Score – Quality of Life
Scale from 0 (best; delighted) to 6 (worst; terrible) Follow‐up: 24 months MCID: 0.5 points |
176 (2 RCTs) | ⊕⊕⊝⊝ Lowa,d | — | Quality of life of RCTs ranged from 0.96 to 1.4 | MD 0.50 higher (0.03 lower to 1.04 higher) | There may be little to no difference in quality of life improvement from PAE compared to TURP. |
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Major adverse events Follow‐up: 24 months MCID: relative risk reduction/increase of 0.25 |
206 (2 RCTs) | ⊕⊝⊝⊝ Very lowa,e | RR 0.91 (0.20 to 4.05) | Study population | We are very uncertain whether PAE results in more or fewer major adverse events than TURP. | |
| 135 per 1000 | 12 fewer per 1000 (108 fewer to 411 more) | |||||
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Retreatmentf Follow‐up: after 24 months MCID: relative risk reduction/increase of 0.25 |
81 (1 RCT) | ⊕⊕⊕⊝ Moderatea | RR 3.80 (1.32 to 10.93) | Study population | PAE likely increases retreatment rates. | |
| 85 per 1000 | 238 more per 1000 (27 more to 845 more) | |||||
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Erectile function assessed with International Index of Erectile Function‐5 Scale from 1 (worst; severe) to 25 (best; normal) Follow‐up: 12 months MCID: 5 points |
81 (1 RCT) | ⊕⊕⊝⊝ Lowa,d | — | Erectile function of RCT was 11.28 | MD 3.09 higher (0.76 lower to 6.94 higher) | There may be little to no difference in erectile function between PAE and TURP. |
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Ejaculatory disorders Follow‐up: 24 months MCID: relative risk reduction/increase of 0.25 |
50 (1 RCT) | ⊕⊕⊝⊝ Lowa,d | RR 0.67 (0.45 to 0.98) | Study population | PAE may reduce ejaculatory disorder compared to TURP. | |
| 840 per 1000 | 277 fewer per 1000 (462 fewer to 17 fewer) | |||||
| *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). CI: confidence interval; MCID: minimal clinically important difference; MD: mean difference; NRS: non‐randomized study; PAE: prostatic arterial embolization; RCT: randomized controlled trial; RR: risk ratio; TURP: transurethral resection of prostate. | ||||||
| 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 one level for study limitations: RCT, unclear risk of selection and reporting bias/high risk of performance or detection bias (–1) /NRS, overall serious or critical risk of bias according to risk of bias tool to assess non‐randomized studies of interventions (–2). bDowngraded one level for inconsistency due to clinical important heterogeneity with high I2 values. cNot downgraded further for imprecision; wide confidence intervals attributed to observed inconsistency (for which we rated down). dDowngraded one level for imprecision: confidence intervals crossed assumed threshold of clinically important difference. eDowngraded two levels for imprecision: wide confidence intervals crossed assumed threshold of clinically important difference. fCertainty evidence of RCTs was higher than NRSs (Appendix 1).