MedTrace Logo

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

NCT05506124 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2023-04-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

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

Sponsors & Collaborators

  • Zhenwei Xie

    lead OTHER

Principal Investigators

  • Zhenwei Xie, MD · Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-09-30
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05506124 on ClinicalTrials.gov