Evaluation of Integrated Optimization Schemes for Female Stress Incontinence (EIOSFSI)

September 21, 2021 updated by: Shanghai Yueyang Integrated Medicine Hospital
The aim of this study is to determine the effectiveness of PFMT added to EA vs PFMT added sham EA for SUI in women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We will perform a multicenter, randomized, double-blind, sham-controlled, parallel-group clinical trial in four hospitals in China to compare the effectiveness of EA added to PFMT vs sham EA added to PFMT for women with SUI.

The participated women with SUI will be recruited from four participating hospitals or through community clinics by advertising. Participated hospitals include: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine (Shanghai, China); Shaanxi Hospital of Traditional Chinese Medicine (Xi'an, China); First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (Tianjin, China); and Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine (Nanjing, China).

Patients will be screened for eligibility. Chief complaint, medical history, and general characteristics (such as age, race, education level, body mass index, manner of child delivery, menopause) will be obtained. Those who met inclusion criteria and are interested in participating in the study will sign an informed consent form and then make another appointment to complete the baseline data collection, including the 72-hr bladder diary, 1-h pad test, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score, the weekly mean number of urine pads used). Participants will then be assigned randomly to either a PFMT (3 sets/day for 8 weeks) + EA (3 times per week for 8 weeks) group or a PFMT + sham EA group. The primary and secondary outcome will be measured from week 2 to 32. The participant-reported severity of UI and subjective self-evaluation of therapeutic effects will be recorded. Written informed consent will be obtained from all participants before they are included in the study. All clinical investigations will be conducted according to the principles of the Declaration of Helsinki.

Study Type

Interventional

Enrollment (Actual)

358

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Department of Acupuncture and Moxibustion, Nanjing Hospital of Chinese Medicine, Nanjing University of Chinese Medicine
    • Shaanxi
      • Xi'an, Shaanxi, China, 710003
        • Department of Acupuncture and Moxibustion, Shaanxi Hospital of Traditional Chinese Medicine
    • Shanghai
      • Shanghai, Shanghai, China, 200437
        • Department of Acupuncture and Moxibustion, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
    • Tianjin
      • Tianjin, Tianjin, China, 300193
        • Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women who are 40-75 years of age
  • Involuntary leakage of urine during increased intra-abdominal pressure in the absence of a bladder contraction, such as coughing, sneezing, or other physical activities
  • a 1-hour pad test exceeds 1 g
  • no other treatments are administered for urinary incontinence currently

Exclusion Criteria:

  • Subject has urgency and mixed urinary
  • Subjects with pelvic organ prolapse, pregnancy, a history of pelvic surgery, chronic respiratory diseases, urinary tract infection, cardiac pacemaker installation, metal allergy, severe needle fear, and currently taking medications for SUI or psychological disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electroacupuncture Added to Pelvic Floor Muscle Training
Patients will be in a prone position. Bilateral Zhongliao (BL33) and Huiyangacupoint (BL35) will be identified and punctured by an acupuncturist. The electrodes will be placed on the needle handles, and stimulate for 30 minutes at 50 Hz with a current intensity between 1 to 5 mA. PFMT will be performed 3 sets a day (morning, around noon, and night).
Behavioral: Pelvic floor muscle training
Device: Electroacupuncture group
Other Names:
  • SDA-V electroacupuncture apparatus(Huatuo,made in China)
Experimental: Sham Electroacupuncture Added to Pelvic Floor Muscle Training
The preparation for the patients will be the same as that for the patients who will receive EA. Whereas, instead of using real acupuncture needles, special designed placebo needles (size 0.30 × 25 mm) with the blunt-head will be used in the PFMT+sham EA group to penetrate the fixed pad to the skin surface but without skin penetration. The same procedure for deqi will be performed as in the PFMT+EA group. A special-designed cable (the intermediate wire of the cable is cut off but the appearance is normal) will be used to connect the electrodes to the electroacupuncture machine. Therefore, the electroacupuncture machine appears to work, but does not actually stimulated acupoints. The sham EA treatment will also be maintained for 30 minutes. PFMT will be performed 3 sets a day (morning, around noon, and night),
Behavioral: Pelvic floor muscle training
Device: Sham electroacupuncture group
Other Names:
  • Sham SDZ-V electroacupuncture apparatus(Huatuo,China)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of urine loss
Time Frame: The evaluation will be performed when the participants are first distributed into the groups as a baseline, and then at weeks 2, 4, 6 and 8 of treatment.
The change of urine loss is measured by the 1-hour urine pad test. The 1-hour pad test will be performed as follows: 1) Empty the bladder and wear a preweighted pad. 2) Drink 500 ml of sodium-free liquid in 15 minutes; 3) walk for half hours, including going up and down stairs; 4) perform the following activity in the remaining 30 minutes: squat and stand up 10 times; cough hard 10 times; run in place for 1 minute; bend down to pick up a small object on the ground 5 times; wash hands for 1 minute with running water. 5) Weigh the pad again to calculate the urine leakage (1 gram equivalent to 1 ml of urine).
The evaluation will be performed when the participants are first distributed into the groups as a baseline, and then at weeks 2, 4, 6 and 8 of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The average 24-hour urinary incontinence episodes and reduction of more than 50%
Time Frame: The average 24-hour urinary incontinence episodes and reduction of more than 50% at weeks 2, 4, 6, and 8 of treatment measured by a urinary diary. Reduction more than 50% in urine leakage at week 8 from baseline measured by the 1-hour pad test.
The average 24-hour urinary incontinence episodes and reduction of more than 50% measured by a urinary diary. Reduction more than 50% in urine leakage at week 8 from baseline measured by the 1-hour pad test.
The average 24-hour urinary incontinence episodes and reduction of more than 50% at weeks 2, 4, 6, and 8 of treatment measured by a urinary diary. Reduction more than 50% in urine leakage at week 8 from baseline measured by the 1-hour pad test.
The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) scores
Time Frame: The evaluation will be performed at baseline, weeks 4, 6, 8 of treatment, and weeks 20 and 32 of follow-up.
The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) scores (range, 0 [best]-21[worst]), which is recommended by the International Consultation on Urological Diseases (ICUD) to evaluate the frequency and volume of urinary incontinence and its impact on quality of life
The evaluation will be performed at baseline, weeks 4, 6, 8 of treatment, and weeks 20 and 32 of follow-up.
Participants using urine pads
Time Frame: week 2-8, week 17-20, week 29-32
The numbers of participants using urine pads and weekly mean pads usage measured by a urinary diary.
week 2-8, week 17-20, week 29-32
severity of urinary incontinence
Time Frame: weeks 2, 4, 6, and 8
The participant-reported severity of urinary incontinence at weeks 2, 4, 6, and 8 of treatment (mild leaking, several drops; moderate leaking,wet through underwear; severe leaking, wet through trousers)
weeks 2, 4, 6, and 8
Subjective self-evaluation of therapeutic effects
Time Frame: week 2, week 4, week 6, week 8, week 20, week 32
3 point scoring: totally unhelpful=0, minimally helpful=1, moderately helpful=2, very helpful=3
week 2, week 4, week 6, week 8, week 20, week 32
Incidence of adverse events
Time Frame: the 1-8 weeks
subcutaneous edema, fatigue, severe pain, palpitations, etc.
the 1-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Yueyang Integrated Medicine Hospital

Investigators

  • Study Chair: Yuelai Chen, Doctor, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2014

Primary Completion (Actual)

June 9, 2017

Study Completion (Actual)

November 21, 2017

Study Registration Dates

First Submitted

September 21, 2021

First Submitted That Met QC Criteria

September 21, 2021

First Posted (Actual)

September 22, 2021

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChiCTR-IPR-15006711
  • 2012BAI24B01 (Other Grant/Funding Number: the Ministry of Science and Technology of PRC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data are available for the editorial office and other investigators following reasonable requests. A data use agreement needs to be signed. There may be handling and processing costs, depending on the complexity and scope of the request.

IPD Sharing Time Frame

one year after the data are published

IPD Sharing Access Criteria

Data are available for the editorial office and other investigators following reasonable requests. A data use agreement needs to be signed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Study Data/Documents

  1. Individual Participant Data Set

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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