Airbag-type Stretchable Electrode Array（ASEA） for Electrical Stimulation in Urinary Incontinence in Postmenopausal Women

Study Overview
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Brief Summary
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The prevalence of urinary incontinence increases after the menopause and affects between 38 % and 55 % of women aged over 60 years. Urinary incontinence has a profound impact on quality of life. Pelvic floor muscle training is the first-line management for urinary incontinence. Electrical stimulation is considered for improving contraction of pelvic floor muscles and aid motivation and adherence to therapy and commonly used in pelvic floor muscle training in clinic therapy. However, the stability and quality of the signals collected by existing stretchable electronics (two-channel hard electrode) are too poor especially when muscle movement is involved, making them inappropriate for aureate pelvic floor muscle training. Here, we propose a physiology-based design method for the stretchable electronics and a novel airbag-type stretchable electrode array (ASEA) device for pelvic floor muscle training. In this study, the investigators hypothesis that ASEA is effective in controlling UI. A randomized, open, and controlled study will be implemented. participants with ASEA will be included and be prescribed. Two-channel hard electrode as electrical stimulation electrode will be used as positive control.The primary efficacy end points is the reduction of symptom scoring and improving of quality-of-life assessment, the frequency of UI at 12th week assessed with bladder diaries and pad testing, and the quality-of-life assessed with incontinence impact questionnaire short form (IIQ-7) and pelvic organ prolapsed-urinary incontinence sexual questionnaire-12(PISQ-12). The adverse event and medication compliance will be investigated. The aim of this study is to explore the efficacy, safety and therapy of ASEA as electrical stimulation electrode in management of UI. This study will provide new options of electrode for the electrical stimulation in management of UI, which will help improve precision therapy of UI.

Detailed Description
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The prevalence of the condition increases with age, and it is reported to affect 58%-84% of elderly women. Pelvic floor muscle training is the first-line management for urinary incontinence. Electrical stimulation is considered for improving contraction of pelvic floor muscles and aid motivation and adherence to therapy and commonly used in pelvic floor muscle training in clinic therapy. However, the stability and quality of the existing stretchable electronics are too poor especially when muscle movement is involved, making them inappropriate for high standard clinical treatment. Here, we propose a novel airbag-type stretchable electrode array (ASEA) device for training of the female pelvic floor muscle (PFM) for the treatment of UI. The aim of this study is to explore the efficacy and safety of in management of UI. In this study, the investigators hypothesis that ASEA device therapy is effective in controlling UI. A randomized, open, and controlled study will be implemented. Subjects were recruited in strict accordance the inclusion and exclusion criteria at the outpatient clinic. Patients with UI with Ingelman sundberg graduation (mild, moderate, moderate)≥mild UI will be included. Eligible subjects were randomized according to a computer-generated randomization schedule to to receive two-channel hard electrode or ASEA in a ratio of 1:1. Specific doctors will be designated for the disease diagnosis and treatment. The investigators were guided by Urinary incontinence and pelvic organ prolapse in women: management (NICE guideline,2019). The primary efficacy end points is the reduction of symptom scoring and improving of quality-of-life assessment. Bladder diaries and pad testing will be to performed to evaluate the frequency and quantify urine loss. The quality-of-life assessed with incontinence impact questionnaire short form (IIQ-7) and pelvic organ prolapsed- urinary incontinence sexual questionnaire-12 (PISQ-12), the higher the score, the greater the impact on the quality of life. The specification of the CONSORT case report system will be implemented. Sample size assessment according equivalence study. Follow-up and loss cases were strictly controlled. A two-sided test will performed with beta=0.80 and αlpha=0.05. The expected loss rate is calculated at 10%. 29 cases will be enrolled with 58 cases in each group. The study will be accepted regular monitoring and inspection.

Official Title
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Gynecology Department of Women's Hospital School of Medicine Zhejiang University

Conditions
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Urinary Incontinence, Pelvic Floor Muscle Training

Intervention / Treatment
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* Device: airbag-type stretchable electrode array (ASEA) device
* Device: two-channel hard electrode device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Clinical diagnosis of UI Have a history of sex Menopause≥1 year Exclusion Criteria: Acute reproductive organ inflammation With cardiac pacemakers Malignant tumors History of pelvic radiotherapy Pelvic floor surgery≤6 months Any disease or symptom that may affect the implementation of the study or the interpretation of the results Participate in other clinical trials at the same time

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br>Propose a novel airbag-type stretchable electrode array (ASEA) device for training of the female pelvic floor muscle (PFM) for the treatment of UI | Device: airbag-type stretchable electrode array (ASEA) device<br>* Propose a novel airbag-type stretchable electrode array (ASEA) device for electrical stimulation for training of the female pelvic floor muscle (PFM) for the treatment of UI<br>|
| Active Comparator: group 2<br>Propose a two-channel hard electrode device for training of the female pelvic floor muscle (PFM) for the treatment of UI | Device: two-channel hard electrode device<br>* Propose a two-channel hard electrode device for electrical stimulation for training of the female pelvic floor muscle (PFM) for the treatment of UI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of quality of life | Use a validated urinary incontinence-specific symptom and quality-of-life questionnaire as follows: Urinary incontinence impact questionnaire IIQ-7, Pelvic organ prolapse / urinary incontinence sexual function questionnaire PISQ-12, Each questionnaire the maximum score is 100 and the minimum score is 0, the higher the score, the worse quality of life. | Baseline score, Change from Baseline score at 12 weeks | 
| The change of quantify urine loss | The change of urine loss measured by pad test. A pad weight gain≥ 2 g is positive. Mild: 2 g≤ weight gain <5 g; Moderate: 5 g ≤ weight gain < 10 g; Severe: 10 g ≤ weight gain < 50 g; extremely severe Degree: weight gain≥ 50 g. The increasing of weight gain means UI aggravation, while the reduction of weight gain means effective. | Baseline weight gain, Change from Baseline weight gain at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of symptom scoring | Bladder diaries to record the frequency of symptom scoring. The increasing of frequency of symptom scoring means UI aggravation, while the reduction of frequency of symptom scoring means effective. | Baseline frequency of symptom scoring, Change from Baseline frequency of symptom scoring at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary incontinence, Pelvic floor muscle training, Pelvic Floor Muscle Electrical Stimulation, Stretchable electronics