A Chinese Herbal Decoction for Stress Urinary Incontinence

NCT ID: NCT02616952

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-12-31

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.

Conditions

Urinary Incontinence, Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Chinese herbal therapy group

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

Group Type: EXPERIMENTAL

Chinese herbal therapy

Intervention Type: 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.

Pelvic floor muscle training group

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.

Group Type: OTHER

Pelvic floor muscle training

Intervention Type: 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.

Interventions

Chinese herbal therapy

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.

Intervention Type: DIETARY_SUPPLEMENT

Pelvic floor muscle training

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Yiqi Suoquan Tang; Kegel Exercise

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Ran Pang

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ran Pang, MD

Role: PRINCIPAL_INVESTIGATOR

Guang'anmen hospital

Locations

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2014S292

Identifier Type: -

Identifier Source: org_study_id