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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence; Pelvic Floor Muscle Training
• Intervention / Treatment: Device: airbag-type stretchable electrode array (ASEA) device; Device: two-channel hard electrode device

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhenwei Xie, MD; Phone Number: +8613588030456; Email: xiezw@zju.edu.cn
• Study Contact Backup: Name: Zujuan Zhang, PhD; Phone Number: +8618868728206; Email: 5312056@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Women's Hospital School of Medicine Zhejiang University
      • Contact: Zhenwei Xie, MD; Phone Number: 8613588030456; Email: xiezw@zju.edu.cn
      • Contact: Zujuan Zhang, PhD; Phone Number: 8618868728206; Email: 5312056@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group 1; 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; 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
Active Comparator: group 2; 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; Propose a two-channel hard electrode device for electrical stimulation for training of the female pelvic floor muscle (PFM) for the treatment of UI

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zhenwei Xie
• Investigators: Principal Investigator: Zhenwei Xie, MD, Zhejiang University

Publications and helpful links

General Publications

• Wu JM, Vaughan CP, Goode PS, Redden DT, Burgio KL, Richter HE, Markland AD. Prevalence and trends of symptomatic pelvic floor disorders in U.S. women. Obstet Gynecol. 2014 Jan;123(1):141-148. doi: 10.1097/AOG.0000000000000057.
• Zuchelo LTS, Bezerra IMP, Da Silva ATM, Gomes JM, Soares Junior JM, Chada Baracat E, de Abreu LC, Sorpreso ICE. Questionnaires to evaluate pelvic floor dysfunction in the postpartum period: a systematic review. Int J Womens Health. 2018 Aug 8;10:409-424. doi: 10.2147/IJWH.S164266. eCollection 2018.
• Tinelli A, Malvasi A, Rahimi S, Negro R, Vergara D, Martignago R, Pellegrino M, Cavallotti C. Age-related pelvic floor modifications and prolapse risk factors in postmenopausal women. Menopause. 2010 Jan-Feb;17(1):204-12. doi: 10.1097/gme.0b013e3181b0c2ae.
• Koenig I, Luginbuehl H, Radlinger L. Reliability of pelvic floor muscle electromyography tested on healthy women and women with pelvic floor muscle dysfunction. Ann Phys Rehabil Med. 2017 Nov;60(6):382-386. doi: 10.1016/j.rehab.2017.04.002. Epub 2017 Jul 14.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): September 30, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Pelvic floor muscle training; Urinary incontinence; Pelvic Floor Muscle Electrical Stimulation; Stretchable electronics
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: ZDFY2021-4X102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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