NCT02616952

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

November 25, 2015

Last Update Submit

March 27, 2018

Conditions

Urinary Incontinence, Stress

Keywords

Stress urinary incontinenceChinese HerbTraditional Chinese medicinePelvic floor muscle training

Outcome Measures

Primary Outcomes (1)

  • Change in 24h pad testing

    12 weeks

Secondary Outcomes (3)

  • Change in ICIQ-SF questionnaire

    12 weeks

  • Change in abdominal leak-point pressure

    12 weeks

  • Change in I-QOL questionnaire

    12 weeks

Other Outcomes (1)

  • Adverse events

    12 weeks

Study Arms (2)

Chinese herbal therapy group

EXPERIMENTAL

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

Dietary Supplement: Chinese herbal therapy

Pelvic floor muscle training group

OTHER

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.

Behavioral: Pelvic floor muscle training

Interventions

Chinese herbal therapyDIETARY_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.

Also known as: Yiqi Suoquan Tang
Chinese herbal therapy group
Pelvic floor muscle trainingBEHAVIORAL

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.

Also known as: Kegel Exercise
Pelvic floor muscle training group

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of stress urinary incontinence
  • Must be able to swallow Chinese hebal decoction

You may not qualify if:

  • Urinary tract infection
  • Neurogenic bladder
  • Pelvic organ prolapse \> stage 2
  • Overactive bladder
  • Previous anti-incontinence surgery
  • Post-void residual urine volume (PVR) \> 100ml.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ran Pang, MD

    Guang'anmen hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 25, 2015

First Posted

November 30, 2015

Study Start

December 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations

CN(1)