Table 2.

Changes in Outcomes for Optilume BPH From Baseline Through 12 Months of Follow-up

Outcome	1 Mo	3 Mo	6 Mo	12 Mo
IPSS
No. (paired)	97	94	91	89
Baseline, mean±SD	23.4±5.5	23.3±5.5	23.1±5.5	23.0±5.4
Follow-up, mean±SD	13.4±7.0	12.6±7.2	12.2±7.1	10.9±6.6
Change, mean±SD	−10.0±7.5	−10.7±7.8	−10.9±7.7	−12.1±7.5
% Change (95%CI)	−41.7 (−35.7, −47.8)	−44.7 (−38.1, −51.3)	−46.4 (−39.9, −53.0)	−51.7 (−45.5, −57.8)
P valuea	< .0001	< .0001	< .0001	< .0001
IPSS−quality of life
No. (paired)	97	94	91	89
Baseline, mean±SD	4.6±1.3	4.6±1.3	4.6±1.3	4.6±1.3
Follow-up, mean±SD	3.0±1.6	2.9±1.7	2.6±1.5	2.2±1.5
Change, mean±SD	−1.6±1.9	−1.7±1.8	−2.0±1.8	−2.4±1.9
% Change (95%CI)	−33.4 (−26.1, −40.7)	−36.2 (−29.2, −43.2)	−33.4 (−34.5, −49.8)	−50.9 (−43.9, −57.9)
P valuea	< .0001	< .0001	< .0001	< .0001
Qmax
No. (paired)	79	79	83	82
Baseline, mean±SD	8.9±2.2	8.8±2.1	8.8±2.2	8.7±2.1
Follow-up, mean±SD	17.6±9.0	18.8±9.7	17.2±8.9	19.0±10.3
Change, mean±SD	+8.7±8.9	+10.0±9.5	+8.3±8.7	+10.3±10.2
% Change (95%CI)	104.8 (79.2, 130.3)	120.5 (94.8, 146.1)	101.8 (78.4, 125.1)	125.2 (95.7, 154.7)
P valuea	< .0001	< .0001	< .0001	< .0001
PVR
No. (paired)	83	84	84	82
Baseline, mean±SD	82.2±72.1	84.8±73.1	84.8±73.1	83.2±71.1
Follow-up, mean±SD	61.9±55.5	66.8±69.4	58.9±59.3	58.0±51.2
Change, mean±SD	−22.5±85.2	−19.2±89.0	−25.7±87.2	−25.2±81.3
P valuea	.019	.053	.009	.006
BPH-II
No. (paired)	96	93	91	89
Baseline, mean±SD	6.9±3.0	6.9±3.0	6.8±3.0	6.8±3.0
Follow-up, mean±SD	5.3±3.2	4.5±3.2	2.9±2.8	2.3±2.5
Change, mean±SD	−1.6±3.8	−2.4±3.8	−3.9±3.8	−4.5±3.2
% Change (95%CI)	−3.0 (−21.1, 15.2)	−17.3 (−36.2, 1.6)	−46.7 (−60.6, −32.9)	−63.2 (−71.8, −54.5)
P valuea	< .0001	< .0001	< .0001	< .0001

Abbreviations: BPH, benign prostatic hyperplasia; BPH-II, BPH Impact Index; CI, confidence interval; IPSS, International Prostate Symptom Score; PVR, postvoid residual urine volume; Qmax, peak urinary flow rate; SD, standard deviation.

^aP values for change from baseline for each measure were calculated using a paired t test.