A Chinese Herbal Decoction for Stress Urinary Incontinence

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Urinary Incontinence, Stress

Treatments: Behavioral: Pelvic floor muscle training; Dietary Supplement: Chinese herbal therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02616952

2014S292

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: Female

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Chinese herbal therapy group

Experimental group

Description:

Participants take a Chinese herbal decoction, Yiqi Suoquan Tang, 200ml orally twice a day for 12 weeks.

Treatment:

Dietary Supplement: Chinese herbal therapy

Pelvic floor muscle training group

Other group

Description:

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.

Treatment:

Behavioral: Pelvic floor muscle training