A Chinese Herbal Decoction for Stress Urinary Incontinence
A Chinese Herbal Decoction for Stress Urinary Incontinence
The purpose of this study is to determine whether Yiqi Suoquan Tang, a Chinese Herbal
 decoction, is effective in the treatment of female stress urinary incontinence.
The pilot randomized, controlled trial is aimed to preliminarily assess the effectiveness of
 Yiqi Suoquan Tang, a Chinese Herbal decoction, in the treatment of female stress urinary
 incontinence (SUI). Eligible participants will be randomly allocated to receiving Yiqi
 Suoquan Tang or pelvic floor muscle training (PFMT) using a random number generator in a 1:1
 ratio. To minimize the evaluation bias, the outcome assessors and statisticians will be
 masked to treatment allocation.

 Assuming a two-sided alpha of 0.05, power of 90%, and a 20% drop-out, a sample size of 36
 would be needed for each group. The statistical analysis will be performed based on the
 intention-to-treat principle, which is defined as patients that have received at least one
 treatment. Missing data will be replaced by the last observed value. Continuous variables
 will be compared by Student t test or Mann-Whitney U test; categorical variables will be
 analyzed by chi-square test, Fisher's exact test or Kruskal-Wallis H test as appropriate. For
 comparison between two time points, paired t-test or Wilcoxon signed rank test will be used
 as appropriate. A statistically significant difference was set at P<0.05.
Inclusion Criteria:

 -  Clinical diagnosis of stress urinary incontinence

 -  Must be able to swallow Chinese hebal decoction

 Exclusion Criteria:

 -  Urinary tract infection

 -  Neurogenic bladder

 -  Pelvic organ prolapse > stage 2

 -  Overactive bladder

 -  Previous anti-incontinence surgery

 -  Post-void residual urine volume (PVR) > 100ml.