. 2019 May 25;2019(5):CD012832. doi: 10.1002/14651858.CD012832.pub2

Summary of findings 3. PUL compared to sham for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia (short term).

PUL compared to sham for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia (short term)
Participants: men with BPH Setting: multicentre in US, Canada, and Australia Intervention: PUL Control: sham
Outcomes	No of participants  (studies)	Certainty of the evidence  (GRADE)	Relative effect  (95% CI)	*Anticipated absolute effects (95% CI)**
Outcomes	No of participants  (studies)	Certainty of the evidence  (GRADE)	Relative effect  (95% CI)	Risk with sham (short term)	Risk difference with PUL
Urological symptom scores  assessed with: International Prostate Symptom Score: 0 (best; not at all) to 35 (worst; almost always) Follow‐up: mean 3 months	206  (1 RCT)	⊕⊕⊝⊝  Low^a,b	—	The mean change of urological symptom scores was –5.9	MD 5.2 lower  (7.44 lower to 2.96 lower)
Quality of life  assessed with: International Prostate Symptom Score – Quality of Life  Scale from: 0 (best; delighted) to 6 (worst; terrible) Follow‐up: mean 3 months	206  (1 RCT)	⊕⊕⊕⊝  Moderate^a	—	The mean change of quality of life was –1	MD 1.2 lower  (1.67 lower to 0.73 lower)
Major adverse events  Follow‐up: mean 3 months	206  (1 RCT)	⊕⊝⊝⊝  Very low^a,c	RR 3.30  (0.41 to 26.28)	Study population
Major adverse events  Follow‐up: mean 3 months	206  (1 RCT)	⊕⊝⊝⊝  Very low^a,c	RR 3.30  (0.41 to 26.28)	15 per 1000	35 more per 1000  (9 fewer to 383 more)
Retreatment Follow‐up: mean 3 months	206  (1 RCT)	⊕⊕⊝⊝  Low^a,d	Not estimable	—	—
Erectile function  assessed with: International Index of Erectile Function‐5  Scale from: 1 (worst; severe erectile dysfunction) to 25 (best; no erectile dysfunction) Follow‐up: mean 3 months	197  (1 RCT)	⊕⊕⊕⊝  Moderate^a	—	The mean change of erectile function was 1.5	MD 1.4 lower  (3.24 lower to 0.44 higher)
Ejaculatory function  assessed with: Male Sexual Health Questionnaire for Ejaculatory Dysfunction  Scale from: 1 (worst) to 15 (best) Follow‐up: mean 3 months	144  (1 RCT)	⊕⊕⊕⊝  Moderate^e,f	—	The mean change of ejaculatory function was 1.7	MD 0.5 higher  (0.38 lower to 1.38 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 prostatic hyperplasia; CI: confidence interval; MD: mean difference; PUL: prostatic urethral lift; RCT: randomized controlled trial; RR: risk ratio.
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: high risk of performance.  ^bDowngraded one level for imprecision: confidence interval crossed assumed threshold of clinically important difference.  ^cDowngraded two levels for imprecision: wide confidence interval crossed assumed threshold of clinically important difference.  ^dDowngraded one level for imprecision: very rare event.  ^eDowngraded one level for study limitations: high risk of performance or attrition bias, or both.  ^fMinimal clinically important difference: 25% improvement (greater than 2 points) from the baseline (PUL: 8.7; sham: 8.8).