Status Approved
First Submitted Date
2018/10/16
Registered Date
2018/11/16
Last Updated Date
2018/11/07
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0003357 |
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Unique Protocol ID | 1041849-201806-BM-056-02 |
Public/Brief Title | Effect of neuromuscular electrical stimulation using novel device on pelvic floor muscle and gluteus muscle strength, lumbopelvic stability, bladder neck mobility and sexual function in patients with stress urinary incontinence |
Scientific Title | Effect of neuromuscular electrical stimulation using novel device on pelvic floor muscle and gluteus muscle strength, lumbopelvic stability, bladder neck mobility and sexual function in patients with stress urinary incontinence |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 1041849-201806-BM-056-02 |
Approval Date | 2018-07-11 |
Institutional Review Board Name | Yonsei University Wonju Institutional Review Board |
Institutional Review Board Address | 1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do |
Institutional Review Board Telephone | 033-760-5238 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Oh-yun Kwon |
Title | Professor |
Telephone | +82-33-760-2971 |
Affiliation | Yonsei University |
Address | 1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do, Republic of Korea Baekwwonkwan 224 |
Contact Person for Public Queries | |
Name | Ui-jae Hwang |
Title | Researcher |
Telephone | +82-70-5014-6120 |
Affiliation | Yonsei University |
Address | 1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do, Republic of Korea Baekwwonkwan 224 |
Contact Person for Updating Information | |
Name | Ui-jae Hwang |
Title | Researcher |
Telephone | +82-70-5014-6120 |
Affiliation | Yonsei University |
Address | 1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do, Republic of Korea Baekwwonkwan 224 |
4. Status
Study Site | Multi-center Number of center : 2 | |
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Overall Recruitment Status | Active, not recruiting | |
Date of First Enrollment | 2018-08-27 Actual | |
Target Number of Participant | 72 | |
Primary Completion Date | 2018-12-28 , Anticipated | |
Study Completion Date | 2019-01-31 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Yonsei University | |
Recruitment Status | Active, not recruiting | |
Date of First Enrollment | 2018-08-27 , | |
Recruitment Status by Participating Study Site 2 | ||
Name of Study | Shera Women's clinic GBGY & Dermatology | |
Recruitment Status | Active, not recruiting | |
Date of First Enrollment | 2018-08-27 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Yonsei University |
Organization Type | University |
Project ID | 2018-51-0213 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Yonsei University |
Organization Type | University |
7. Study Summary
Lay Summary | Because stress incontinence is a problem as it gets older, there is a growing interest in it and there is increasing burden over the management of stress incontinence. According to the International Continence Society, stress urinary incontinence is defined as an involuntary major effort, or a phenomenon in which urine is leaked during a cough or cough. Previous studies have shown that 10% of all women experience urine leakage at least once a week and 50% of all types of urinary incontinence (stress, urgency, and mixed) are stress incontinence, of which 25-45% Have been reported to experience frequent leakage of urine. In the United States, the cost of products and initial treatment visits to prevent incontinence is estimated at $ 13.1 billion annually. It has been reported that stress incontinence is generally manifested by two mechanisms. The first is attributed to the urethral hypermobility caused by weakening of the tissue supporting the urethra and secondly by the weakening of the urethral sphincter, which is defined as Intrinsic Sphincter Deficiency (ISD). In 1923, Victor Bonney reported that the loss of support of the urethra based on the observation of non-ideal downward movement of the anterior wall of the vagina in women with stress urinary incontinence was the result of stress incontinence. In 1961, Enhorning introduced the theory of pressure transfer, which is the cause of stress due to the weakening of the urethra from the pelvis due to the weakening of the supporting structure close to the urethra. The internal abdominal pressure is not transmitted to the urethra. Based on this, a method of elevating the bladder neck by supporting the back of the pubic bone was popularized. In 1990, Delancey proposed a hammock theory that defined the supporting structure at the base of the pelvis as a hammock and served as a stable barrier when the hammock was pressurized by increased internal pressure of the urethra. The problems caused by incontinence may be not only a decrease in quality of life due to incontinence but also a decrease in female sexual function. Subjects with stress urinary incontinence have been reported to have poor quality of life due to the psychological burden of urinary leakage during sex due to weakening of the pelvic floor muscle, and to decrease sexual satisfaction and less sexual function during sexual intercourse. In addition, at the contraction of the pelvic floor muscle, the abdominal muscles and the contralateral muscles contract simultaneously. The weakening of the pelvic floor muscles leads to the simultaneous weakening of the contracting muscles, which can reduce the stability of the back pelvis. This can lead to muscle weakness. Surface electrical stimulation is widely used to shrink the pelvic floor muscle by electrical stimulation. Since the surface electrical stimulation method is noninvasive, electrical stimulation through the skin induces contraction of the pelvic floor muscle. However, among the surface electric stimulation methods, when the stimulation is inserted into the vagina or the anus, it is difficult for the subjects to easily use because the pain or irritation site is sensitive, the maintenance of cleanliness is difficult, and it causes discomfort. Recently, a combined pelvic base muscle electrical stimulation combined with pads that can stimulate the pelvic basal ganglia between the pubic bone nodule and the buttock nodule without inserting it into the vagina or anus, and between the sacral bones (S2-4).The purpose of this study was to investigate the effects of pelvic floor muscle electrical stimulation on the muscle strength, urinary incontinence, urethra and motor function and sexual function of the pelvic floor muscles and muscles of the pelvis when exercised for 8 weeks. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Supportive Care |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Open |
Allocation | RCT |
Intervention Type | Others (electronical stimulation device (EasyK7) for pelvic floor muscle training) |
Intervention Description | The experimental group with stress urinary incontinence received free pelvic base muscle electrical stimulation device (EasyK7), and electric stimulation training using pelvic floor muscle electrical stimulation device was performed twice a day (15 minutes for 1 trial) for 8 weeks do. The strength of the electrical stimulation of the pelvic floor muscle electrical stimulation device can be adjusted to 60 steps, and the electric stimulation exercise is performed so that the subject does not inconvenience the use of the intensity control. |
Number of Arms | 2 |
Arm 1 |
Arm Label Experimental group: electrical stimulation for pelvic floor muscle training in participants with stress urinary incontinence |
Target Number of Participant 36 |
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Arm Type Experimental |
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Arm Description The experimental group with stress urinary incontinence received free pelvic base muscle electrical stimulation device (EasyK7), and electric stimulation training using pelvic floor muscle electrical stimulation device was performed twice a day (15 minutes for 1 trial) for 8 weeks do. |
|
Arm 2 |
Arm Label Control group: non-training in participants with stress urinary incontinence |
Target Number of Participant 36 |
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Arm Type Active comparator |
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Arm Description The control group will perform the control without any training and treatment for 8 weeks, and will receive pelvic floor stimulation after 8 weeks. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (N00-N99)Diseases of the genitourinary system (N39.3)Stress incontinence |
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Rare Disease | No |
Inclusion Criteria |
Gender Female |
Age 30Year~60Year |
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Description 1) Subjects who were clinically diagnosed with stress incontinence 2) Subjects who experienced leakage of urine during the last 3 months 3) Body mass index Body mass index (BMI) <30 kg / m² 4) Subjects with age between 30 and 60 5) Subjects who are not addicted to drugs or alcohol 6) Subjects who can perform the questionnaire or medical diagnosis successfully |
|
Exclusion Criteria |
1) Subjects with Urogenital prolapse grade III or higher 2) Subjects with Pacemaker 3) Subjects who are allergic to electric stimulation or gel pad 4) Subjects with artificial joints in the hip or pelvis 5) Subjects with chronic systemic, neurological and connective tissue diseases 6) Those who are pregnant or have a pregnancy plan 7) Subjects who are extremely sensitive to electrical stimulation and unable to train pelvic floor muscle electrical stimulation 8) Patients who have had surgery on the pelvic or abdomen in the past 6 months 9) Subjects with cognitive impairment 10) Subjects who did not fully participate in pelvic floor muscle electrical stimulation training 11) Subjects with blood disorders or diabetes, hypertension |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | UDI-6 Incontinence Severity Questionnaire: Quality of life for urinary incontinence |
|
Timepoint | It is measured in the post-test after the initial measurement (pre-test) and 8-week training. |
|
Primary Outcome(s) 2 | ||
Outcome | Incontinence Quality of Life (IQOL) Questionnaire: social and avoidance behavior factor by incontinence |
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Timepoint | It is measured in the post-test after the initial measurement (pre-test) and 8-week training. |
|
Primary Outcome(s) 3 | ||
Outcome | Female sexual function index: sexual function, satisfaction, desire and lubrication |
|
Timepoint | It is measured in the post-test after the initial measurement (pre-test) and 8-week training. |
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Primary Outcome(s) 4 | ||
Outcome | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire: psychological, physical and social fator by incontinence |
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Timepoint | It is measured in the post-test after the initial measurement (pre-test) and 8-week training. |
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Secondary Outcome(s) 1 | ||
Outcome | Cough positive stress test |
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Timepoint | It is measured in the post-test after the initial measurement (pre-test) and 8-week training. |
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Secondary Outcome(s) 2 | ||
Outcome | Ultra-short perineal pad test |
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Timepoint | It is measured in the post-test after the initial measurement (pre-test) and 8-week training. |
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Secondary Outcome(s) 3 | ||
Outcome | Urethral hypermobility using Ultrasound |
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Timepoint | It is measured in the post-test after the initial measurement (pre-test) and 8-week training. |
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Secondary Outcome(s) 4 | ||
Outcome | Vaginal volume and pelvic floor muscle strength and power |
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Timepoint | It is measured in the post-test after the initial measurement (pre-test) and 8-week training. |
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Secondary Outcome(s) 5 | ||
Outcome | Lumbopelvic stability test: one leg loading test |
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Timepoint | It is measured in the post-test after the initial measurement (pre-test) and 8-week training. |
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Secondary Outcome(s) 6 | ||
Outcome | Hip abductor strength test |
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Timepoint | It is measured in the post-test after the initial measurement (pre-test) and 8-week training. |
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Secondary Outcome(s) 7 | ||
Outcome | Hip extensor strength test |
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Timepoint | It is measured in the post-test after the initial measurement (pre-test) and 8-week training. |
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Secondary Outcome(s) 8 | ||
Outcome | Hip adductor strength test |
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Timepoint | It is measured in the post-test after the initial measurement (pre-test) and 8-week training. |
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Secondary Outcome(s) 9 | ||
Outcome | Pelvic floor muscle contraction using Ultrasound |
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Timepoint | It is measured in the post-test after the initial measurement (pre-test) and 8-week training. |
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Secondary Outcome(s) 10 | ||
Outcome | Diaphragm excursion (tidal and maximal) using Ultrasound |
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Timepoint | It is measured in the post-test after the initial measurement (pre-test) and 8-week training. |
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Secondary Outcome(s) 11 | ||
Outcome | Lateral abdominal wall thickness using Ultrasound |
|
Timepoint | It is measured in the post-test after the initial measurement (pre-test) and 8-week training. |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2019. 9 |
Way of Sharing | Available on Request
(Please contact us if you need data. Ui-jae Hwang (hwangu33@nate.com)) |
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