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

NCT05506124 | Unknown

• 1 other identifier: ZDFY2021-4X102
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Urinary Incontinence; Pelvic Floor Muscle Training

Keywords

Urinary incontinence; Pelvic floor muscle training; Pelvic Floor Muscle Electrical Stimulation; Stretchable electronics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• The change of symptom scoring

  Baseline frequency of symptom scoring, Change from Baseline frequency of symptom scoring at 12 weeks

Study Arms (2)

group 1

EXPERIMENTAL

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

group 2

ACTIVE COMPARATOR

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

Interventions

airbag-type stretchable electrode array (ASEA) device 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

group 1

two-channel hard electrode device 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

group 2

Eligibility Criteria

• Age: 40 Years - 70 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of UI
• Have a history of sex
• Menopause≥1 year

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhenwei Xie: lead

Study Sites (1)

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 24463674 BACKGROUND

• 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.

  PMID: 30123009 BACKGROUND

• 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.

  PMID: 19629013 BACKGROUND

• 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.

  PMID: 28716538 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhenwei Xie, MD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenwei Xie, MD

CONTACT

+8613588030456; xiezw@zju.edu.cn

Zujuan Zhang, PhD

CONTACT

+8618868728206; 5312056@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: profressor

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: August 18, 2022
• Study Start: September 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)