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| Name | Class |
|---|---|
| The Scientific and Technological Research Council of Turkey | OTHER |
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This study was planned to examine and compare the effects of standard diaphragm exercises with Pelvic floor muscle exercises (PFME) and 360-degree expanded diaphragm exercises with PFME on urinary symptoms, PFM functions and quality of life in women with stress urinary incontinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 360 Degree Expanded Diaphragm Exercises | Experimental | Volunteers who complain of urinary incontinence in situations such as coughing, sneezing and laughing, who have been diagnosed with stress or stress-predominant mixed urinary incontinence by a Gynecology and Obstetrics physician, and who meet the inclusion criteria will be included in the study. |
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| Standard Diaphragm Exercises | Active Comparator | Volunteers who complain of urinary incontinence in situations such as coughing, sneezing and laughing, who have been diagnosed with stress or stress-predominant mixed urinary incontinence by a Gynecology and Obstetrics physician, and who meet the inclusion criteria will be included in the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic floor muscle training with 360 degree expanded diaphragm exercises | Other | Women in this group will be taught 360-degree expanded diaphragm exercises with the Ohmbelt device. Two Ohmbelt devices will be used in this study. The anterior sensor will be placed in the inguinal cavity to visualize the expansion of the anterior abdominal wall, and the posterior sensor will be placed contralaterally in the upper lumbar triangle to visualize the expansion of the posterior wall. The protocol of breathing exercises is inspiration and expiration time of 6 seconds, 10 repetitions and 3 sets. Pelvic floor muscle training will be given with the NeuroTract Myoplus 4 PRO EMG biofeedback device. The training protocol: Each patient will be asked to contract close to the maximum pelvic floor muscle contraction for slow muscle contraction, maintain the contraction for 6-8 seconds, and then perform fast muscle contractions 3-4 times. This cycle is 1 set, 8-12 repetitions. A total of 3 sets will be applied. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Pelvic floor muscle contraction during Valsalva | Pelvic floor muscle contraction during Valsalva will be evaluated with the NeuroTract Myoplus 4 PRO EMG device. A disposable, cylindrical endovaginal probe will be used to record pelvic floor muscle electromyographic activity. The evaluation will be carried out as stated in previous studies, and the women are told: "Take as deep a breath as possible, pinch your nose with your thumb and index finger and close your mouth, try to breathe out against the now closed respiratory system." instructions will be given. For a clearer understanding, the expression "pretend to strain" will also be used. The probe will be manually supported by the investigator throughout the testing procedure to prevent the pressure probe from moving and losing contact with the PTK during evaluation. 2 seconds of reflex PFM activity will be recorded in μV. | at baseline, at 8th week |
| Measure | Description | Time Frame |
|---|---|---|
| Change of urinary symptoms | The severity of women's incontinence will be questioned with the Incontinence Severity Index. | at baseline, at 8th week |
| Change of quality of life score | Urinary incontinence symptoms and their impact on quality of life will be evaluated with the International Urinary Incontinence Questionnaire Form. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seda Yakıt Yeşilyurt, PhD | Izmir University of Economics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Izmir University of Economics | Izmir | Turkey (Türkiye) |
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This is a prospective double-blind randomized controlled study.
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| Pelvic floor muscle training with standard diaphragm exercises | Other | Women in this group will be taught standard diaphragm exercises. In the supine position, with the head and knees supported by a pillow, the patient will first be asked to close his or her eyes to focus. With one hand on the chest and the other hand on the abdomen, "Take a deep breath through your nose and direct all the air as much as possible under your lower hand. inflate your belly. Now exhale all the air slowly through your mouth." The protocol of breathing exercises is inspiration and expiration time of 6 seconds, 10 repetitions and 3 sets. Pelvic floor muscle training will be given with the NeuroTract Myoplus 4 PRO EMG biofeedback device. The training protocol: Each patient will be asked to contract close to the maximum pelvic floor muscle contraction for slow muscle contraction, maintain the contraction for 6-8 seconds, and then perform fast muscle contractions 3-4 times. This cycle is 1 set, 8-12 repetitions. A total of 3 sets will be applied. |
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| at baseline, at 8th week |
| Change of Pelvic floor muscle maximum voluntary contraction | Maximum voluntary contraction of women will be evaluated with the NeuroTract Myoplus 4 PRO EMG device. A disposable, cylindrical endovaginal probe will be used to record pelvic floor muscle electromyographic activity. MVC, average peak activation results during three PFM contractions will be expressed in μV and percentage (%). | at baseline, at 8th week |
| Change of maximum inspiratory pressure | A non-invasive, RP Check brand electronic pressure measuring device (MD Diagnostics Ltd., Maidstone, UK) will be used to measure maximum inspiratory pressure. | at baseline, at 8th week |
| Change of maximum expiratory pressure | A non-invasive, RP Check brand electronic pressure measuring device (MD Diagnostics Ltd., Maidstone, UK) will be used to measure maximum expiratory pressure. | at baseline, at 8th week |
| Subjective perception of improvement | Women's subjective perception of improvement was assessed using the Global Perception of Improvement scale | at 8th week |
| Change of Social Activity Participation | The Social Activity Index will be used, in which nine social situations are selected to represent situations in which women have problems in social participation due to urinary incontinence. | at baseline, at 8th week |
| Change of average number of urinary incontinence | Women will be asked to complete a bladder diary reflecting the daily activity patterns of the bladder for 3 consecutive days. | at baseline, at 8th week |
| Change of Pelvic floor muscle strength | Vaginal palpation method will be used to measure pelvic floor muscle strength. (Modified Oxford Scale) | at baseline, at 8th week |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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