Table 2.
Females (N = 34) | Males (N = 5) | All (N = 39) | |
---|---|---|---|
WIE | |||
V2 – V0 | −9.2 (8.20) (− 12.08; – 6.35)* | − 8.5 (7.21) (− 17.45;0.45) | −9.1 (7.99) (− 11.72; – 6.53)* |
V3 – V0 | − 10.6 (10.50) (− 14.32; – 6.88)* | − 10.5 (10.68) (− 23.71;2.81) | −10.6 (10.37) (− 13.99; – 7.17)* |
V4 – V0 | −11.0 (10.62) (− 14.66; – 7.25)* | − 10.8 (8.83) (− 21.75;0.18) | −10.9 (10.31) (− 14.27; – 7.59)* |
Wexner score | |||
V2 – V0 | −14.9 (4.85) (− 16.6; – 13.2)* | − 17.0 (1.00) (− 18.2; – 15.8)* | −15.2 (4.58) (− 16.7; – 13.7)* |
V3 – V0 | − 15.6 (4.56) (− 17.2; – 14.0)* | −19.0 (1.00) (− 20.2; – 17.8)* | −16.1 (4.41) (− 17.5; – 14.6)* |
V4 – V0 | − 16.2 (3.66) (− 17.5; – 15.0)* | − 18.8 (1.30) (− 20.4; – 17.2)* | −16.6 (3.55) (− 17.7; – 15.4)* |
VAS | |||
V2 – V0 | −4.17 (2.27) (− 5.02; – 3.32)* | − 2.59 (1.71) (− 4.71; – 0.47)* | −3.95 (2.25) (− 4.72; – 3.17)* |
V3 – V0 | −4.01 (2.42) (− 4.92; – 3.11)* | −3.53 (2.11) (− 6.16; – 0.91)* | −3.95 (2.35) (− 4.75; – 3.14)* |
V4 – V0 | −4.31 (2.65) (− 5.32; – 3.30)* | −4.04 (2.72) (− 7.42; – 0.66)* | −4.27 (2.62) (− 5.19; – 3.36)* |
Data presented as mean (standard deviation) (95% confidence interval)
WIE weekly incontinence episodes, VAS visual analogue scale, ITT intention to treat, N number of values, V visit, V0 implantation, V2, V3 and V4 1, 6 and 12 months post implantation
*Significant change from baseline according to 95% confidence interval