A Chinese Herbal Decoction for Stress Urinary Incontinence
- Conditions
- Urinary Incontinence, Stress
- Registration Number
- NCT02616952
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 72
- Clinical diagnosis of stress urinary incontinence
- Must be able to swallow Chinese hebal decoction
- Urinary tract infection
- Neurogenic bladder
- Pelvic organ prolapse > stage 2
- Overactive bladder
- Previous anti-incontinence surgery
- Post-void residual urine volume (PVR) > 100ml.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in 24h pad testing 12 weeks
- Secondary Outcome Measures
Name Time Method Change in abdominal leak-point pressure 12 weeks Change in I-QOL questionnaire 12 weeks Change in ICIQ-SF questionnaire 12 weeks
Trial Locations
- Locations (1)
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
🇨🇳Beijing, Beijing, China
Guang'anmen Hospital, China Academy of Chinese Medical Sciences🇨🇳Beijing, Beijing, China