Airbag-type Stretchable Electrode Array(ASEA) for Electrical Stimulation in Urinary Incontinence in Postmenopausal Women
Primary Purpose
Urinary Incontinence, Pelvic Floor Muscle Training
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
airbag-type stretchable electrode array (ASEA) device
two-channel hard electrode device
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence focused on measuring Urinary incontinence, Pelvic floor muscle training, Pelvic Floor Muscle Electrical Stimulation, Stretchable electronics
Eligibility Criteria
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
Sites / Locations
- Women's Hospital School of Medicine Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
group 1
group 2
Arm Description
Propose a novel airbag-type stretchable electrode array (ASEA) device for training of the female pelvic floor muscle (PFM) for the treatment of UI
Propose a two-channel hard electrode device for training of the female pelvic floor muscle (PFM) for the treatment of UI
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05506124
Brief Title
Airbag-type Stretchable Electrode Array(ASEA) for Electrical Stimulation in Urinary Incontinence in Postmenopausal Women
Official Title
Gynecology Department of Women's Hospital School of Medicine Zhejiang University
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhenwei Xie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Pelvic Floor Muscle Training
Keywords
Urinary incontinence, Pelvic floor muscle training, Pelvic Floor Muscle Electrical Stimulation, Stretchable electronics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Experimental
Arm Description
Propose a novel airbag-type stretchable electrode array (ASEA) device for training of the female pelvic floor muscle (PFM) for the treatment of UI
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
Propose a two-channel hard electrode device for training of the female pelvic floor muscle (PFM) for the treatment of UI
Intervention Type
Device
Intervention Name(s)
airbag-type stretchable electrode array (ASEA) device
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
two-channel hard electrode device
Intervention Description
Propose a two-channel hard electrode device for electrical stimulation for training of the female pelvic floor muscle (PFM) for the treatment of UI
Primary Outcome Measure Information:
Title
The change of quality of life
Description
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.
Time Frame
Baseline score, Change from Baseline score at 12 weeks
Title
The change of quantify urine loss
Description
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.
Time Frame
Baseline weight gain, Change from Baseline weight gain at 12 weeks
Secondary Outcome Measure Information:
Title
The change of symptom scoring
Description
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.
Time Frame
Baseline frequency of symptom scoring, Change from Baseline frequency of symptom scoring at 12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenwei Xie, MD
Phone
+8613588030456
Email
xiezw@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zujuan Zhang, PhD
Phone
+8618868728206
Email
5312056@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenwei Xie, MD
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Hospital School of Medicine Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenwei Xie, MD
Phone
8613588030456
Email
xiezw@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Zujuan Zhang, PhD
Phone
8618868728206
Email
5312056@zju.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24463674
Citation
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.
Results Reference
background
PubMed Identifier
30123009
Citation
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.
Results Reference
background
PubMed Identifier
19629013
Citation
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.
Results Reference
background
PubMed Identifier
28716538
Citation
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.
Results Reference
background
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Airbag-type Stretchable Electrode Array(ASEA) for Electrical Stimulation in Urinary Incontinence in Postmenopausal Women
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