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Completed

NCT Number: NCT02616952

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.

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Key information

Conditions

Urinary Incontinence, Stress Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chinese herbal therapy

Dietary Supplement

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.

Other names: Yiqi Suoquan Tang

Pelvic floor muscle training

Behavioral

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 names: Kegel Exercise

Primary outcomes

  1. Change in 24h pad testing

    Time frame: 12 weeks

Secondary outcomes

  1. Change in ICIQ-SF questionnaire

    Time frame: 12 weeks

  2. Change in abdominal leak-point pressure

    Time frame: 12 weeks

  3. Change in I-QOL questionnaire

    Time frame: 12 weeks

Other outcomes

  1. Adverse events

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Official study title

Effect of Yiqi Suoquan Tang, a Chinese Herbal Decoction, on Stress Urinary Incontinence

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 30, 2015
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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