A Chinese Herbal Decoction for Stress Urinary Incontinence
Condition: Urinary Incontinence, Stress
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Chinese herbal therapy; Pelvic floor muscle training
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): Participants take a Chinese herbal decoction, Yiqi Suoquan Tang, 200ml orally twice a day for 12 weeks. The Yiqi Suoquan Tang are composed of Radix Astragali 30 g, Radix Codonopsis pilosula 10g, Radix Angelica sinensis 10g, Radix Atractylodis Macrocephalae 10g, Fructus Alpiniae Oxyphyllae 10g, Radix Lindera aggregata 6g, Rhizoma Dioscoreae 10g, pericarpium citri reticulatae 10g, Rhizoma Cimicifuga 10g, Radix Bupleuri 10g, Fructus Rubi 15g, and Semen raphani 10g. All the decoctions are provided by the Department of Pharmacy, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, and are packed in opaque plastic bags with 200 ml for each one.; In intensive exercises, participants are taught how to identify the muscles: 1) identify anal sphincter/feel anus, and try to raise it from chair (without adding abdominal, thigh, and buttock muscles) with a position of sitting; 2) identify levator ani and try to raise vagina from chair (without adding abdominal, thigh, and buttock muscles) with a position of Sitting, bent forward, elbows on knees; 3) contract levator ani with a position of sitting, lying, and standing; 4) contract anal sphincter with a position of sitting, lying, and standing. Once the participants can identify the muscles, they are asked to do a set consists of 10 contractions, each lasting 5 seconds, with a 5 seconds break between contractions. Then they need to do same procedure 3 times daily as the home exercises.
Other intervention name(s): Yiqi Suoquan Tang; Kegel Exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stress urinary incontinence; Chinese Herb; Traditional Chinese medicine; Pelvic floor muscle training