Urinary Incontinence,Stress Clinical Trial
Official title:
Effectiveness of Functional Magnetic Stimulation and Pelvic Floor Muscle Training on Pelvic Floor Muscle Function, Urinary Incontinence Symptoms and Quality of Life in Women With Stress Urinary Incontinence
Verified date | April 2023 |
Source | Lithuanian Sports University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this randomized controlled trial is to evaluate and compare the effects of functional magnetic stimulation and pelvic floor muscle training on pelvic floor muscle function, urinary incontinence symptoms and quality of life in women with stress urinary incontinence. The main questions it aims to answer are: - What is the effect of functional magnetic stimulation on pelvic floor muscle function, symptoms of urinary incontinence and quality of life in women with stress urinary incontinence? - What is the effect of pelvic floor muscle training program on pelvic floor muscle function, symptoms of urinary incontinence and quality of life in women with stress urinary incontinence? - Which intervention is more effective - functional magnetic stimulation or pelvic floor muscle training program? Participants will be evaluated before and after the intervention with the following methods: - International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF); - Incontinence Impact Questionnaire-Short Form (IIQ-7); - Pelvic floor muscle strength and endurance will be assessed with a "Pelvexiser" perineometer.
Status | Completed |
Enrollment | 48 |
Est. completion date | October 30, 2021 |
Est. primary completion date | October 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 29 Years to 49 Years |
Eligibility | Inclusion Criteria: - complains of stress incontinence for at least 4 weeks; - women who have given birth. Exclusion Criteria: - pregnancy; - vaginism; - urinal infection; - oncological disorders; - epilepsy; - skin problems; - if they had an implanted heart pacemaker, metal implants. |
Country | Name | City | State |
---|---|---|---|
Lithuania | Lithuanian Sports University | Kaunas |
Lead Sponsor | Collaborator |
---|---|
Lithuanian Sports University |
Lithuania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urinary incontinence symptoms and quality of life (International Consultation on Incontinence Questionnaire) | ICIQ - SF - International Consultation on Incontinence Questionnaire - Short Form is intended to subjectively evaluate the symptoms of urinary incontinence in a woman or man and the impact of those symptoms on the quality of life. The questionnaire consists of four questions. The first two questions assess the symptoms of urinary incontinence experienced, the third question describes quality of life and the fourth question determines which type of incontinence the person has. The scores of the first three questions are summed up, the maximum number of points collected is 21, the minimum is 0. Depending on the number of points collected, the severity of urinary incontinence symptoms is assessed: no urinary incontinence symptoms (0 points), mild urinary incontinence symptoms (1 - 5 points), moderate incontinence symptoms (score 6-12), severe incontinence symptoms (score 13-18) and very severe incontinence symptoms (19-21). | Change from Baseline Urinary Incontinence symptoms at 6 weeks | |
Primary | IIQ-7 -Incontinence Impact Questionnaire | The IIQ-7 questionnaire is designed to assess the impact of urinary incontinence on quality of life. The questionnaire consists of seven questions, which can be answered to find out the impact of urinary incontinence on all areas of life: physical activity, traveling, social activity, relationships, emotional state. Each question is evaluated from 0 to 3 points. The higher the score, the worse the quality of life. The maximum number of collected points is 100, the minimum is 0. <50 points is considered a good quality of life, 50-70 points is an average quality of life, >70 points is a poor quality of life. | Change from Baseline Incontinence Impact Questionnaire scores at 6 weeks | |
Primary | Perineometry | The strength and endurance of the subjects' pelvic floor muscles was assessed with a Pelvexiser perineometer (Wolfram Haboeck Co., Austria). This apparatus has been scientifically proven as an objective method of assessing the function of the pelvic floor muscles and an effective exerciser for strengthening the pelvic floor muscles, which is why it is often used in the presence of for urinary incontinence problems. The Pelvexiser can provide varying resistance to the pelvic floor muscles and provide real-time feedback on pelvic floor muscle contractions and changes (Chitra et al., 2010). | Change from Baseline Perineometry at 6 weeks |
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