Table 3.
Variables | Placebo | MAG-EPA | Difference between Group | |||||
---|---|---|---|---|---|---|---|---|
Mean (SE) | MD (95% CI) | p-Value * | Mean (SE) | MD (95% CI) | p-Value * | MD (95% CI) | p-Value ** | |
EPIC-26 | ||||||||
Urinary Incontinence | ||||||||
Randomization | 94.5 (2.0) | 0.0 | 94.2 (1.9) | 0.0 | ||||
3 Months Post-RP | 47.3 (3.7) | −47.2 (−55.3; −39.2) | <0.0001 | 37.1 (3.8) | −57.2 (−65.3; −48.9) | <0.0001 | −7.2 (−17.9; 3.4) | 0.18 |
6 Months Post-RP | 66.4 (4.1) | −28.1 (−36.9; −19.3) | <0.0001 | 58.3 (4.3) | −35.9 (−45.2; −26.7) | <0.0001 | −4.7 (−16.5; 7.2) | 0.44 |
9 Months Post-RP | 70.8 (3.8) | −23.7 (−31.6; −15.7) | <0.0001 | 65.7 (4.1) | −28.5 (−37.1; −19.9) | <0.0001 | −1.4 (−12.6; 9.7) | 0.80 |
12 Months Post-RP | 74.4 (3.9) | −19.1 (−28.0; −12.1) | <0.0001 | 65.8 (4.1) | −28.6 (−37.1; −20.2) | <0.0001 | −4.4 (−15.9; 7.2) | 0.45 |
Urinary irritation | ||||||||
Randomization | 85.2 (2.1) | 0.0 | 82.5 (2.0) | 0.0 | ||||
3 Months Post-RP | 78.9 (2.3) | −6.3 (−11.4; −1.3) | 0.01 | 77.0 (2.3) | −5.4 (−10.5; −0.3) | 0.04 | 0.3 (−5.9; 6.4) | 0.93 |
6 Months Post-RP | 85.1 (2.0) | −0.1 (−4.5; 4.3) | 0.95 | 85.8 (2.0) | 3.3 (−1.2; 7.7) | 0.15 | 2.1 (−2.9; 7.0) | 0.41 |
9 Months Post-RP | 87.5 (1.9) | 2.3 (−1.3; 6.0) | 0.21 | 85.3 (1.9) | 2.9 (−0.8; 6.5) | 0.12 | 0.7 (−3.8; 5.1) | 0.77 |
12 Months Post-RP | 84.4 (2.0) | −0.8 (−5.0; 3.5) | 0.72 | 87.3 (2.0) | 4.9 (0.6; 9.2) | 0.03 | 5.5 (0.4; 10.6) | 0.03 |
Sexual function | ||||||||
Randomization | 66.3 (3.6) | 0.0 | 63.2 (3.5) | 0.0 | ||||
3 Months Post-RP | 19.0 (3.0) | −47.3 (−54.6; −40.0) | <0.0001 | 18.8 (3.0) | −44.4 (−51.7; −37.1) | <0.0001 | −0.7 (−8.5; 7.1) | 0.86 |
6 Months Post-RP | 28.1 (3.6) | −38.2 (−45.8; −30.6) | <0.0001 | 27.4 (3.8) | −35.8 (−43.6; −28.0) | <0.0001 | −1.2 (−10.6; 8.2) | 0.80 |
9 Months Post-RP | 33.0 (3.8) | −33.3 (−40.8; −25.8) | <0.0001 | 31.4 (4.0) | −31.8 (−39.6; −24.1) | <0.0001 | −2.3 (−12.2; 7.6) | 0.65 |
12 Months Post-RP | 36.2 (4.3) | −30.1 (−38.1; −22.2) | <0.0001 | 32.4 (4.5) | −30.8 (−39.0; −22.6) | <0.0001 | −3.8 (−15.1; 7.5) | 0.50 |
Bowel function | ||||||||
Randomization | 93.1 (1.7) | 0.0 | 90.3 (1.6) | 0.0 | ||||
3 Months Post-RP | 92.8 (1.8) | −0.3 (−4.3; 3.7) | 0.86 | 88.5 (1.8) | −1.8 (−5.8; 2.2) | 0.38 | −3.2 (−8.2; 1.7) | 0.20 |
6 Months Post-RP | 93.6 (1.4) | 0.5 (−2.6; 3.7) | 0.75 | 91.5 (1.4) | 1.2 (−1.9; 4.5) | 0.45 | −1.6 (−5.2; 2.0) | 0.37 |
9 Months Post-RP | 94.3 (1.7) | 1.2 (−2.8; 5.2) | 0.56 | 89.9 (1.8) | −0.4 (−4.5; 3.7) | 0.85 | −2.4 (−6.8; 2.0) | 0.28 |
12 Months Post-RP | 96.2 (1.3) | 3.0 (−0.3; 6.4) | 0.07 | 93.9 (1.3) | 3.6 (0.3; 6.9) | 0.03 | −1.0 (−4.4; 2.4) | 0.55 |
Hormonal function | ||||||||
Randomization | 86.3 (2.0) | 0.0 | 87.9 (1.9) | 0.0 | ||||
3 Months Post-RP | 88.0 (1.9) | 1.6 (−1.4; 4.6) | 0.29 | 87.2 (1.9) | −0.7 (−3.8; 2.4) | 0.64 | −1.2 (−5.2; 2.9) | 0.57 |
6 Months Post-RP | 88.7 (1.5) | 2.4 (−0.3; 5.1) | 0.08 | 89.2 (1.6) | 1.3 (−1.4; 3.9) | 0.35 | −0.2 (−3.2; 2.8) | 0.90 |
9 Months Post-RP | 87.8 (1.6) | 1.4 (−1.8; 4.6) | 0.38 | 88.6 (1.7) | 0.7 (−2.5; 3.9) | 0.66 | 0.5 (−3.3; 4.3) | 0.80 |
12 Months Post-RP | 88.3 (1.7) | 1.9 (−1.3; 5.1) | 0.24 | 90.4 (1.7) | 2.5 (−0.7; 5.7) | 0.12 | 1.7 (−2.2; 5.6) | 0.38 |
IPSS | ||||||||
Voiding and storage Problem | ||||||||
Randomization | 9.1 (0.9) | 0.0 | 9.0 (0.9) | 0.0 | ||||
3 Months Post-RP | 11.1 (1.0) | 1.9 (−0.3; 4.2) | 0.08 | 11.1 (1.0) | 2.2 (−0.1; 4.4) | 0.06 | −0.3 (−2.9; 2.4) | 0.85 |
6 Months Post-RP | 7.8 (0.7) | −1.3 (−3.0; 0.5) | 0.15 | 8.4 (0.8) | −0.6 (−2.4; 1.1) | 0.48 | 0.2 (−1.6; 2.0) | 0.81 |
9 Months Post-RP | 7.0 (0.7) | −2.2 (−3.8; −0.5) | 0.009 | 7.2 (0.8) | −1.8 (−3.5; −0.2) | 0.03 | −0.1 (−1.9; 1.7) | 0.91 |
12 Months Post-RP | 7.0 (0.7) | −2.1 (−3.8; −0.5) | 0.01 | 6.4 (0.7) | −2.6 (−4.2; −0.9) | 0.002 | −0.9 (−2.8; 0.9) | 0.30 |
Notes: MAG-EPA: monoacylglyceride-conjugated eicosapentaenoic acid; RP: radical prostatectomy. * p-value were obtained using mixed models adjusted for age. BMI and NCCN risk; ** p-value were obtained by mixed models adjusted for age, BMI, NCCN risk, and baseline score.