Urinary Incontinence Clinical Trial
Official title:
Dose-response of Physical Exercise on Pelvic Floor Muscle Function in Postmenopausal Women With Urinary Incontinence: a Randomized Controlled Trial
NCT number | NCT04351750 |
Other study ID # | A-BR-108-091 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2020 |
Est. completion date | May 24, 2021 |
Verified date | June 2022 |
Source | National Cheng Kung University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Urinary incontinence (UI) symptoms are highly prevalent among women, and menopause is one of the risk factors for UI. During the menopausal transition, not only the hormonal secretion is changed but also the level of physical activity is affected. The time spent on physical activity is reduced in postmenopausal women. Studies have shown that physical activity acts in a bidirectional manner, exerting either a preventive or an aggravating effect on urinary incontinence. Individuals with sedentary lifestyle and insufficient physical activity (< 150 min/week) are at risk of developing UI, and regular physical activity exerts a protective effect in preventing UI, but the optimal type, duration, and intensity of exercise for the female older adult population remain unknown. In addition, objective measurements of pelvic floor muscle function is needed as the use of self-reported measures may cause response bias. The aim of the study is to investigate the effect of different intensity of exercise on pelvic floor muscle function and HRQoL in postmenopausal women with UI. The investigators hypothesize that (a) both high- and low-intensity physical activities can improve pelvic floor muscle strength and HRQoL in postmenopausal women with UI, and (b) the improvement in high-intensity group is higher than that in low-intensity group. A randomized trial will be conducted to compare the effect of different exercise intensity on pelvic floor muscle function in postmenopausal women with urinary incontinence (n=90).
Status | Completed |
Enrollment | 47 |
Est. completion date | May 24, 2021 |
Est. primary completion date | May 24, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A to 80 Years |
Eligibility | Inclusion Criteria: - Postmenopausal women: amenorrhoea for longer than 12 months. - Symptomatic UI: The questionnaire for urinary incontinence diagnosis (QUID) score >0 - Sedentary lifestyle: < 150 minutes of moderate-intensity aerobic physical activity throughout the week, or < 75 minutes of vigorous-intensity aerobic physical activity throughout the week, or an equivalent combination of moderate and vigorous-intensity activity - Able to answer the questionnaire correctly (no language barrier or cognitive problems) - No other physical or psychological problem that would interfere participation in the study - No concurrent outpatient rehab attendance / supervised exercise Exclusion Criteria: - Use hormone therapy - Age >80 y/o - Neurological condition: Spinal cord injury, multiple sclerosis, transverse myelitis, cerebrovascular accident - Radical surgery for pelvis, sling, and prolapse surgery - Malignancy for bladder, urethra, uterus, ovary, cervix, and rectum - Overflow incontinence or voiding dysfunction |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Cheng Kung University | Tainan |
Lead Sponsor | Collaborator |
---|---|
National Cheng Kung University |
Taiwan,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pelvic Floor Muscle Function Measured by Digital Palpation | Pelvic floor muscle function (muscle strength) was measured through digital palpation. Three times of maximum contraction holding for five seconds with an interval resting of five seconds were performed, and the maximum value among three was recorded as the muscle strength of maximal voluntary contraction (MVC). The result was recorded using the modified Oxford grading scale, a six-point system with higher score indicated stronger muscle strength (0 = no contraction, 1 = flicker, 2 = weak, 3 = moderate with lift, 4 = good with lift, 5 = strong with lift). | absolute values at 8 weeks | |
Primary | Pelvic Floor Muscle Function Measured by Manometry | The manometry supplied by Laborie® Biofeedback and Stimulation System was used to assess vaginal squeeze pressure, and the unit of pressure was registered in millimeter of mercury (mmHg). The participants were asked to perform 3 times of MVC, holding for 5 seconds with 5 seconds interval resting time, and the maximum value among the three MVC was recorded. The muscle strength was calculated as the value of MVC minus resting tone. | absolute values at 8 weeks | |
Secondary | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form | The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form will be used to assess the severity of UI symptoms. The total score ranges from 0 to 21; a higher score indicates greater severity. | absolute values at 8 weeks | |
Secondary | International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life | The International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life will be used to evaluate quality of life in UI patients. The total score ranges from 19 to 76. A higher score indicates greater impact on quality of life. | absolute values at 8 weeks | |
Secondary | International Prostate Symptom Score | The International Prostate Symptom Score will be used to evaluate the severity of lower urinary tract symptoms. The total score ranges from 0 to 35. A higher score indicates greater severity. | absolute values at 8 weeks | |
Secondary | 3-day Bladder Diary | The participants had to record the frequency of daytime urination for three days but not necessarily consecutive. Daytime frequency was defined as the number of voids since first void after waking to last void before sleep. | absolute values at 8 weeks | |
Secondary | International Physical Activity Questionnaire | The International Physical Activity Questionnaire will be used to measure participants' physical activity levels. The questionnaire assessed the time people spending in physical activity in the last seven days, and the intensity of physical activity level was divided into vigorous, moderate, and walking. The total physical activity levels were calculated by a formula: total MET-minutes/week (Metabolic equivalent of task- minutes per week) = Vigorous intensity (8.0 METs*min*day) + Moderate intensity (4.0 METs*min*days) + Walking (3.3 METs*min*days). A higher score indicates a greater physical activity levels. | absolute values at 8 weeks |
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