Summary of findings 3. PAE compared to sham for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia (short term).
| Patient or population: men with lower urinary tract symptoms suggesting benign prostatic hyperplasia Setting: RCT/single center/Portugal Intervention: PAE Comparison: sham | ||||||
| Outcomes | No of participants (studies) | Certainty of evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | What happens? | |
| Risk with sham | Risk difference with PAE | |||||
|
Urologic symptom scores
assessed with International Prostate Symptom Score
Scale from 0 (best; not at all) to 35 (worst; almost always)
Follow‐up: 6 months MCID: 3 points |
80 (1 RCT) | ⊕⊕⊕⊝ Moderatea | — | Change in urologic symptom scores was –5.03 | MD 12.07 lower (15.45 lower to 8.69 lower) | PAE likely improves urologic symptom scores compared to sham. |
|
Quality of life
assessed with International Prostate Symptom Score – Quality of Life
Scale from 0 (best; delighted) to 6 (worst; terrible)
Follow‐up: 6 months MCID: relative risk reduction/increase of 0.5 |
80 (1 RCT) | ⊕⊕⊕⊝ Moderatea | — | Change in quality of life was –1.03 | MD 1.97 lower (2.48 lower to 1.46 lower) | PAE likely improves quality of life compared to sham. |
|
Major adverse events Follow‐up: 6 months MCID: relative risk reduction/increase of 0.25 |
80 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b | Not estimablec | Study population | We are very uncertain about the effects of PAE on major adverse events. | |
| — | — | |||||
|
Retreatment Follow‐up: 6 months MCID: relative risk reduction/increase of 0.25 |
80 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b |
Not estimablec | Study population | We are very uncertain about effects of PAE on retreatment. | |
| — | — | |||||
| Erectile function | — | — | — | — | — | Not reported. |
|
Ejaculatory disorders Follow‐up: 6 months MCID: relative risk reduction/increase of 0.25 |
80 (1 RCT) | ⊕⊝⊝⊝ Very lowa,b | Not estimablec | Study population | We are very uncertain about effects of PAE on major adverse events. | |
| — | — | |||||
| *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; PAE: prostatic arterial embolization; RCT: randomized controlled trial. | ||||||
| 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 detection bias. bDowngraded by two levels for imprecision: very rare event. cNo event in both groups.