Evaluation of Integrated Optimization Schemes for Female Stress Incontinence

Study Overview
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Brief Summary
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The aim of this study is to determine the effectiveness of PFMT added to EA vs PFMT added sham EA for SUI in women.

Detailed Description
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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.

Official Title
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Evaluation of Integrated Optimization Schemes for Female Stress Incontinence

Conditions
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Stress Urinary Incontinence in Women

Intervention / Treatment
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* Device: Electroacupuncture group
* Device: Sham electroacupuncture group
* Behavioral: Pelvic floor muscle training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture Added to Pelvic Floor Muscle Training<br>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). | Device: Electroacupuncture group<br> <br> * Other names: SDA-V electroacupuncture apparatus(Huatuo,made in China);Behavioral: Pelvic floor muscle training<br> <br> |
| Experimental: Sham Electroacupuncture Added to Pelvic Floor Muscle Training<br>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), | Device: Sham electroacupuncture group<br> <br> * Other names: Sham SDZ-V electroacupuncture apparatus(Huatuo,China);Behavioral: Pelvic floor muscle training<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of urine loss | 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% | 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 | 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 | 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 | 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 | 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 | subcutaneous edema, fatigue, severe pain, palpitations, etc. | the 1-8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress Urinary Incontinence; Acupuncture