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 2
Changes from baseline at 6 months.
Baseline
6 months
Change from baseline
P-value
Patients with ≥50% decrease from baseline in number of FI episodes, n(%), SE
0
56 (57.1) 0.050
56 (57.1) 0.050
N/A
Total number of FI episodes, mean (SE)
20.8 (1.71)
11.1 (1.84)
−9.7 (1.71)
<.001**
Total number of solid FI episodes, mean (SE)
9.5 (1.28)
5.7 (1.28)
−3.9 (1.32)
<.001**
Total number of loose FI episodes, mean (SE)
11.3 (1.21)
5.4 (0.78)
−5.8 (1.14)
<.001
Total number of FI-free days, mean (SE)
14.0 (0.73)
20.9 (0.73)
6.9 (0.73)
<.001*
Number of controlled bowel evacuations, mean (SE)
22.5 (2.07)
27.0 (2.31)
4.5 (1.86)
.015*
Cleveland Clinic Florida Incontinence Score, mean (SE)
13.5 (0.36)
9.2 (0.50)
−4.3 (0.47)
<.001*
Fecal Incontinence Quality of Life (FIQL) Scores
Lifestyle, mean (SE)
2.4 (0.10)
3.0 (0.10)
0.5 (0.10)
<.001*
Coping/behavior, mean (SE)
1.8 (0.07)
2.3 (0.09)
0.6 (0.10)
<.001*
Depression/self perception, mean (SE)
2.6 (0.10)
3.1 (0.10)
0.5 (0.09)
<.001*
Embarrassment, mean (SE)
1.8 (0.08)
2.5 (0.10)
0.6 (0.10)
<.001*
SE: standard error.
*One-sample t-test; **Wilcoxon onesample test.
