A Chinese Herbal Decoction for Stress Urinary Incontinence

Phase 2

Completed

• Conditions: Urinary Incontinence, Stress
• Interventions: Dietary Supplement: Chinese herbal therapy; Behavioral: Pelvic floor muscle training

• Registration Number: NCT02616952
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Study Timeline

• Study First Submitted: 2015-11-25
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-11-30
• Study Start: 2015-12
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-27
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chinese herbal therapy group	Chinese herbal therapy	Participants take a Chinese herbal decoction, Yiqi Suoquan Tang, 200ml orally twice a day for 12 weeks.
Pelvic floor muscle training group	Pelvic floor muscle training	Pelvic floor muscle training includes intensive exercises and home exercises. Intensive exercises are conducted in hospital once a week while home exercises are performed three times daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change in 24h pad testing	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in ICIQ-SF questionnaire	12 weeks
Change in abdominal leak-point pressure	12 weeks
Change in I-QOL questionnaire	12 weeks

Trial Locations

Locations (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China