Pelvic Floor Muscle Weakness Clinical Trial
Official title:
Comparison of Teaching Methods of Pelvic Floor Muscle Contraction in Women
The aim of our study; To evaluate the effectiveness of different teaching methods on correct pelvic floor muscle contraction in women who have not received pelvic floor muscle training (PFMT) before. Women who come to the gynecology and obstetrics clinic for examination and volunteer for the study will be randomized with a computer-aided randomization program and divided into 3 groups. First of all, the pelvic floor muscles will be evaluated by ultrasonographic method and perineometer. The first group will be taught pelvic floor muscle contraction with verbal explanation, the second group will be taught with digital vaginal palpation, and the third group will be taught pelvic floor muscle contraction with the help of a perineometer. After the training, the same evaluations will be made again. The number of individuals to be included in the study will be determined by power analysis. As a result of this study, it will be decided which method can be used to teach pelvic floor muscle contraction to women accurately and effectively in clinics. The results of our study will guide clinicians in their preferences for using different teaching methods.
Status | Not yet recruiting |
Enrollment | 54 |
Est. completion date | August 30, 2024 |
Est. primary completion date | June 15, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 50 Years |
Eligibility | Inclusion Criteria: - volunteering to participate in the study, getting a score of 25 or more from the "Mini mental Test", having pelvic floor muscle contraction ability, not having received pelvic floor muscle training before, vaginal examination and volunteering for education. Exclusion Criteria: - Pregnancy, presence of symptomatic pelvic organ prolapse over stage 2, cooperation problem, presence of urinary infection, epilepsy, and accompanying neurological disease. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Duygu Sultan Oge |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ASSESSMENT OF THE PELVIC FLOOR USING ULTRASONOGRAPHY (USG) | During evaluation with 2D USG, hiatal aperture measurements will be made at rest and at maximum voluntary contraction. Measurements will be repeated before and after individuals receive training, and any numerical changes that may occur will be recorded[11,12]. | at the beginning 5 minutes, at the end 5 minutes | |
Primary | Pelvic Floor Muscle Strength and Endurance: | Pelvic floor muscle strength and endurance will be evaluated with a non-invasive vaginal perineometer with digital vaginal palpation | 5 minutes | |
Primary | pelvic floor power, minimum and maximum muscle contraction values | Pelvic floor power will be evaluated with intravajinal biofeedback electromyograhy(EMG) | 5 minutes | |
Secondary | DETAILED STORIES OF THE PATIENTS | The physical characteristics of the patients such as age (years), height, weight, BMI, demographic data such as educational status, employment status, and marital status will be recorded. The detailed history will include a CV inquiring about chronic diseases and surgeries, a family history inquiring about diseases in first-degree relatives, and a gynecological history inquiring about previous gynecological diseases and surgeries, if any. The patients' obstetric history, which questions gravida (number of pregnancies), parity (number of births), abortus (number of miscarriages), number of dilations and curettages, type of birth, birth weight and interventions used at birth, will also be recorded. In addition; Menstrual status (regular menstruation, irregular menopause, spontaneous menopause, surgical menopause) will be questioned. | 5 minutes | |
Secondary | Pelvic Floor Health Knowledge Test: | This test, developed and validated by Al-Deges et al., consists of 29 questions. The 'test yes-no-don't know?' which contains questions about pelvic floor health. It is answered with options. This test will be applied to women before they receive pelvic floor training. In this way, the knowledge level of the women included in the study about the pelvic floor will be evaluated[13]. | 5 minutes | |
Secondary | Global Pelvic Floor Disorder Questionnaire(GPFDQ) | GPFDQ, which is used in the evaluation and determination of the severity of stress urinary incontinence, frequent urination, sudden urination, urge incontinence, urination difficulty, pelvic organ prolapse, obstructive defecation, anal incontinence and dyspareunia symptoms, which are frequently encountered in pelvic floor dysfunctions, has been adapted to Turkish, its validity and It is a reliable survey. In our study, we will use this survey to eliminate women's discomfort regarding these problems [14]. | 5 minutes | |
Secondary | Visual Analog Scale (VAS) assessment for pelvic pain | VAS scores will be recorded to question the pelvic pain of the women included in the study. In the 10-centimeter long VAS, 0 indicates no pain, while 10 indicates the most severe pain. Individuals are asked to mark the part on the scale that expresses their pain [15]. | 1 minute | |
Secondary | Determining the severity of incontinence | The International Incontinence Severity Index is used to reveal the severity, frequency and type of urinary incontinence and to show how much urinary incontinence affects the person's quality of life[16]. | 1 minute | |
Secondary | Sensory Evaluation | Sensory test will be performed as a result of sharp-blunt, hot-cold tests applied to the sensory area innervated by the sacral 2-4 segmental nerves, in order to determine whether the patient has any sensory loss in these dermatomes [17]. | 1 minute | |
Secondary | Pelvic Floor Reflex Evaluation: | As part of the neurological examination, evaluation of the pudendal nerve and Sacral 2-4 sacral reflexes should be performed. In evaluating the bulbocavernous reflex, a cotton swab will be passed over the labia minora to check whether both labia contract equally. Secondly, in the anal reflex, the contraction caused by rubbing the cotton swab against the perianal skin will be evaluated[18]. | 1 minute | |
Secondary | Evaluation of Mistakes Made During Pelvic Floor Muscle Contraction | Contraction of abdominal muscles instead of pelvic floor muscles: While the evaluations are being made, biofeedback EMG (NeuroTrac® Myo Plus Pro) superficial electrodes will be placed at the spina iliaca anterior superiors level for possible contraction in the abdominal muscles and the muscle activation response will be recorded in mV..
Contraction of adductor muscles instead of pelvic floor muscles, Contraction of the gluteal muscles instead of the pelvic floor muscles, Excessive breathing, Holding the breath and pushing(7). |
5 minutes | |
Secondary | Pelvic organ prolapse evaluation | to classified pelvic organ prolapse | 1 minute |
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