Clinical Study Abstract for Better Bladder™
Background: Symptoms of overactive bladder (OAB) and urinary incontinence (UI) affect millions of people worldwide, significantly impacting quality of life. Plant based medicines have been documented both empirically and in emerging scientific research to have varying benefits in reducing bladder symptoms. This study assessed the efficacy of Better Bladder, a combination of phytomedicine extracts, Cratevox (Crateva nurvala), Equisetem arvense and Lindera aggregata, formulated to reduce UI and symptoms of OAB such as urinary frequency and/or urgency.
Methods and Findings: : Effects of the herbal combination of crateva, horsetail and lindera on a variety of bladder symptoms compared to an identical placebo, were documented in a randomized, double-blind, placebo controlled trial (n=150). Data were collected at baseline, 2, 4 and 8 weeks. No significant side effects were observed resulting in withdrawal from treatment. Statistical analysis included ordered logistic regression, adjusted for repeated measures to compare mixed effects. At week 8, urinary day frequency was significantly lower (OR 0.01; 95%CI 0.004 to 0.075; p<0.001) in response to treatment (mean ±SD; 7.69 ± 2.15/day) compared to placebo (10.95 ± 2.47/day). Similarly, episodes of nocturia were significantly lower (OR 0.03; 95%CI 0.02 to 0.05) after 8 weeks of treatment (2.16 ± 1.49) versus placebo (3.11 ± 1.37). Symptoms of urgency (OR 0.02; 95%CI 0.004 to 0.04), urgency incontinence (OR 0.04; 95% CI 0.01 to 0.15) and stress incontinence (OR 0.03; 95%CI 0.002 to 0.4) were also significantly lower (all p<0.01) in the treatment group. Significant improvements in quality of life were also reported after treatment in comparison to placebo.
Conclusions: The outcome of this study demonstrated both statistical significance and clinical relevance in reducing UI and symptoms of OAB, such as urinary frequency and/or urgency.
Independent Statistical Analysis
Overactive Bladder and Urinary Incontinence Symptoms Frequency
|
Variable |
Placebo (mean ± SD) |
Better Bladder (mean ± SD) |
OR (95% CI) Placebo vs treatment |
OR (95% CI) Without correction |
p-value |
|
Day frequency (n/day) |
|||||
|
week 0 |
11.57 ± 1.79 |
11.53 ± 1.54 |
0.95 (0.33 to 2.73) |
0.98 (0.824 to 1.157) |
0.831 |
|
week 2 |
10.80 ± 2.44 |
8.94 ± 2.28 |
0.07 (0.04 to 0.13)* |
0.68 (0.601 to 0.763) |
<0.001 |
|
week 4 |
10.60 ± 2.42 |
8.42 ± 2.46 |
0.04 (0.02 to 0.08)* |
0.66 (0.582 to 0.739) |
<0.001 |
|
week 8 |
10.95 ± 2.47 |
7.69 ± 2.15 |
0.01 (0.01 to 0.02)* |
0.49 (0.419 to 0.575) |
<0.001 |
|
Nocturia (n/day) |
|||||
|
week 0 |
3.39 ± 1.52 |
4.02 ± 1.62 |
3.59 (1.39 to 9.21)* |
1.42 (1.202 to 1.678) |
<0.001 |
|
week 2 |
2.94 ± 1.37 |
3.18 ± 1.72 |
0.40 (0.24 to 0.69)* |
1.13 (0.980 to 1.310) |
0.122 |
|
week 4 |
2.92 ± 1.30 |
2.70 ± 1.52 |
0.14 (0.08 to 0.24)* |
0.88 (0.756 to 1.025) |
0.124 |
|
week 8 |
3.14 ± 1.36 |
2.16 ± 1.49 |
0.03 (0.02 to 0.05)* |
0.55 (0.462 to 0.663) |
<0.001 |
|
Urgency (n/day) |
|||||
|
week 0 |
4.34 ± 2.89 |
3.80 ± 1.82 |
0.67 (0.23 to 1.94) |
0.91 (0.832 to 0.993) |
0.032 |
|
week 2 |
3.65 ± 2.62 |
2.32 ± 2.09 |
0.16 (0.09 to 0.27)* |
0.77 (0.699 to 0.857) |
<0.001 |
|
week 4 |
3.52 ± 2.68 |
1.88 ± 2.25 |
0.08 (0.04 to 0.13)* |
0.73 (0.647 to 0.812) |
<0.001 |
|
week 8 |
3.92 ± 2.87 |
1.49 ± 2.31 |
0.02 (0.01 to 0.03)* |
0.61(0.528 to 0.694) |
<0.001 |
|
Urgency Incontinence (n/day) |
|||||
|
week 0 |
2.71 ± 2.68 |
2.79 ± 1.50 |
1.70 (0.53 to 5.40) |
1.02 (0.894 to 1.160) |
0.787 |
|
week 2 |
2.32 ± 1.54 |
1.85 ± 1.78 |
0.19 (0.09 to 0.40)* |
0.84 90.700 to 1.004) |
0.050 |
|
week 4 |
1.82 ± 1.33 |
1.53 ± 2.41 |
0.19 (0.09 to 0.40)* |
0.92 (0.790 to 1.078) |
0.302 |
|
week 8 |
2.44 ± 2.38 |
1.24 ± 2.49 |
0.04 (0.02 to 0.09)* |
0.755 (0.630 to 0.906) |
0.001 |
|
Stress Incontinence (n/day) |
|||||
|
week 0 |
2.19 ± 1.50 |
2.13 ± 1.14 |
0.97 (0.11 to 8.65) |
0.97 (0.649 to 1.448) |
0.883 |
|
week 2 |
1.70 ± 1.49 |
1.27 ± 1.29 |
0.30 (0.07 to 1.29) |
0.79 (0.532 to 1.172) |
0.239 |
|
week 4 |
1.85 ± 1.29 |
0.77 ± 0.94 |
0.06 (0.01 to 0.25)* |
0.35 (0.177 to 0.708) |
0.001 |
|
week 8 |
2.04 ± 1.51 |
0.73 ± 0.87 |
0.03 (0.01 to 0.15)* |
0.37 (0.199 to 0.695) |
<0.001 |
|
Total Incontinence (n/day) |
|||||
|
week 0 |
2.95 ± 2.65 |
3.31 ± 2.12 |
1.97 (0.65 to 5.98) |
1.06 (0.953 to 1.185) |
0.272 |
|
week 2 |
2.56 ± 1.62 |
2.20 ± 2.09 |
0.23 (0.11 to 0.45)* |
0.90 (0.775 to 1.040) |
0.147 |
|
week 4 |
2.14 ± 1.42 |
1.74 ± 2.68 |
0.14 (0.07 to 0.27)* |
0.91 (0.786 to 1.043) |
0.392 |
|
week 8 |
2.70 ± 2.25 |
1.38 ± 2.76 |
0.03 (0.01 to 0.06)* |
0.73 (0.613 to 0.861) |
<0.001 |
Percentage of Subjects Reporting Improvement in Symptom For Each Time Period
|
Variable |
Baseline measure versus follow-up period percent improved |
||
|
2 weeks |
4 weeks |
8 weeks |
|
|
Day frequency |
86.0 |
88.0 |
90.0 |
|
Night frequency |
72.9 |
81.4 |
84.3 |
|
Urgency |
79.4 |
87.3 |
85.7 |
|
Urgency incontinence |
78.1 |
81.2 |
84.4 |
|
Total incontinence |
84.1 |
90.2 |
93.5 |