An Open-Label, Noncomparative, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx Gel as a Bulking Agent for the Treatment of Fecal Incontinence
Table 3
Changes from baseline at 12 months.
Baseline
12 months
Change from baseline
P-value*
Patients with ≥50% decrease from baseline in number of FI episodes, n(%), SE
0
55 (64.0) 0.052
55 (64.0) 0.052
N/A
Total number of FI episodes, mean (SE)
20.6 (1.90)
9.6 (1.81)
−11.0 (1.90)
<.001**
Total number of solid FI episodes, mean (SE)
9.6 (1.41)
3.8 (0.85)
−5.9 (1.52)
<.001**
Total number of loose FI episodes, mean (SE)
10.9 (1.32)
5.9 (1.49)
−5.1 (1.67)
<.001
Total number of FI-free days, mean (SE)
14.1 (0.81)
21.2 (0.88)
7.1 (0.94)
<.001*
Number of controlled bowel evacuations, mean (SE)
23.0 (2.18)
24.4 (2.41)
1.5 (1.81)
.315*
Cleveland Clinic Florida Incontinence Score, mean (SE)
13.4 (0.36)
8.7 (0.50)
−4.7 (0.48)
<.001*
Fecal Incontinence Quality of Life (FIQL) Scores
Lifestyle, mean (SE)
2.4 (0.10)
2.9 (0.09)
0.5 (0.10)
<.001*
Coping/behavior, mean (SE)
1.7 (0.07)
2.4 (0.11)
0.7 (0.11)
<.001*
Depression/self perception, mean (SE)
2.7 (0.10)
3.2 (0.10)
0.5 (0.11)
<.001*
Embarrassment, mean (SE)
1.8 (0.08)
2.6 (0.11)
0.8 (0.11)
<.001*
SE: standard error.
*One-sample -test; **Wilcoxon onesample test.
