The Effectiveness of Pelvic Floor Muscle Exercises and Core Exercises in Menopausal Women With Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Pelvic floor evaluated using the Pelvic Floor Distress Inventory (PFDI - Pelvic Floor Distress Inventionary)
研究概览
简要总结
The prospective and four-arm randomized controlled study was conducted on n = 136 (34 = control, 34 = kegel, 34 = core, 34 = kegel+ core group) menopausal women at Trakya University Health Research and Application Center Urology Polyclinic between Oct 2023 and June 2024. In the first interview, the researcher will apply an information form to all four groups, asking about personal information, habits, bladder irritants and fluid intake-related features, obstetric, gynecological and systemic disease-related features, and stress urinary incontinence-related features. This form will only be filled at the beginning. In addition, the "Pelvic Floor Distress Scale (PFDI)" and "Pelvic Floor Impact Questionnaire (PFIQ)" will be applied and will be repeated by the executive researcher at the 1st, 2nd and 3rd controls. It will be terminated at the 3rd follow-up. Descriptive statistics, Pearson, Spearman's correlation, and regression analyzes will be used in the analysis of research data.
详细描述
In this prospective, randomized-controlled study, menopausal women over the age of 45 who applied to Trakya University Health Research and Application Center Urology Polyclinic with complaints of stress urinary incontinence (stage 1-2) and who do not require surgical or medical treatment of stress urinary incontinence were included in the case and intervention groups. will be divided into four groups:
In the first interview, the researcher will apply an information form to all four groups, asking about personal information, habits, bladder irritants and fluid intake-related features, obstetric, gynecological and systemic disease-related features, and stress urinary incontinence-related features. This form will only be filled at the beginning. In addition, the Pelvic Floor Distress Scale (PFDI); and Pelvic Floor Impact Questionnaire (PFIQ); will be applied and will be repeated by the executive researcher at the 1st, 2nd and 3rd controls. It will be terminated at the 3rd follow-up.
All four groups will be given a 3-day voiding diary, which will be requested at the check-up and must be filled out at home for 3 consecutive days (a voiding diary will be given at each follow-up and they will be asked to bring it at the 1st, 2nd and 3rd follow-up a month later) and will be monitored by the leading researcher. It will be terminated at the 3rd follow-up.
At the 3rd follow-up, where the study was terminated; Trakya University Faculty of Medicine Urology Department, which will perform routine control examinations of diagnosed patients and is involved in the study. Faculty Member Assoc. Dr. Hakan AKDERE and Op. Dr. Hakan ÇAKICI at Private Optimed Hospital Urology Department. Urogynecological evaluation tests (stress test, uroflowmetry, pelvic floor muscle strength measurement, digital palpation) will be requested and will be performed by the researchers in the examination room of the Urology Polyclinic of the applied hospital, paying attention to the privacy of women. The requested urogynecological evaluations will be requested in the 3rd follow-up and are the tests included in the patient follow-up protocol of the specified diagnosis. No evaluation test other than routine evaluation tests is specified.
Pelvic Floor Muscle Exercise (PFME/ Kegel Exercise): Training for PFME will be given orally and will cover the importance of PFME and how to do the exercises, as well as the conditions and frequency of doing the exercises. You will be told that the exercise should be done when the bladder is empty, three times a day (morning, noon and evening) and repeated 10 times in each set. In the first week of exercise, the PFM will be contracted for 3 seconds and relaxed for 3 seconds, and will be increased by 1 second each week. It will be explained that from the 8th week onwards, it will be done by contracting for 10 seconds and relaxing for 10 seconds and will continue. It will be stated that the learning process of pelvic floor muscle exercise may take 6 weeks to 6 months. It will be stated that this exercise should be applied throughout their lives for the sustainability of PFM strength. The training is planned to last approximately 20 minutes. PFME will last for two months. Women in menopause will be given an exercise chart (about how many times a day they should exercise) to guide them in their exercise activities at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate in the study,
- •Those over the age of 45 who are in menopause,
- •Women with coitus (+),
- •Body mass index < 30 kg/m2,
- •Not addicted to alcohol or drugs,
- •Experiences recorded unintentional leakage more than once a week,
- •Those diagnosed with Stage I-II stress urinary incontinence complaints, Patients whose stress incontinence does not require surgical or medical treatment will be included in the study.
排除标准
- •Those who do not volunteer to participate in the study,
- •Women who are under the age of 45 and are not in menopause,
- •Women with (-) coitus,
- •Having a pacemaker installed,
- •Presence of a device implanted in the pelvis or hip joint(s),
- •Having had pelvic or abdominal surgery in the last 6 months,
- •Having a neurological or psychiatric disease,
- •Having a urinary tract infection,
- •Body mass index >30 kg/m2,
- •Those who are addicted to alcohol or drugs,
- •Not experiencing any recorded unintentional leakage events more than once a week,
- •Those diagnosed with Stage III-IV Stress urinary incontinence complaints,
- •Patients requiring surgical and medical treatment of stress incontinence will not be included in the study.
结局指标
主要结局
Pelvic floor evaluated using the Pelvic Floor Distress Inventory (PFDI - Pelvic Floor Distress Inventionary)
时间窗: change from baseline and 1, 2, and 3 months of practice
PFDI is a symptom questionnaire consisting of 20 items used to measure the degree of discomfort caused by pelvic symptoms in women. Each item consists of 4 options (Not at all, Rarely, Moderately, Quite a lot) and is given a score between 1 and 4. PFDI consists of 3 subscales.
Pelvic floor impact evaluated using the Pelvic Floor Impact Questionnaire (PFIQ Pelvic Floor Impact Questionnaire)
时间窗: change from baseline and 1, 2, and 3 months of practice
PFIQ is a pelvic floor quality of life questionnaire used to evaluate the effects of bowel, bladder and/or pelvic symptoms on the individual's daily living activities, social relationships and emotions. Each item consists of 4 options (Not at all, Rarely, Moderately, Quite a lot) and is given a score between 0 and 3. The PFIQ scale also consists of 3 subscales.
次要结局
- Urinary incontinence evaluated using the Stress Test(change from baseline and 1, 2, and 3 months of practice)
- Urinary incontinence evaluated using the Uroflowmetry(change from baseline and 1, 2, and 3 months of practice)
- Urinary incontinence evaluated using the Pelvic Floor Muscle Strength Measurement(change from baseline and 1, 2, and 3 months of practice)
- Urinary incontinence evaluated using the Digital Palpation(change from baseline and 1, 2, and 3 months of practice)
研究者
Burcu KUCUKKAYA
Assist. Prof
Trakya University
