Visceral Osteopathic Manual Therapy Methods in Women With Stress Urinary Incontinence
- Conditions
- Osteopathic Manipulative Treatment (OMT)
- Registration Number
- NCT06874543
- Lead Sponsor
- Istanbul Rumeli University
- Brief Summary
The aim of this study is to evaluate the effect of visceral osteopathic manual therapy method for stress urinary incontinence in female patients. As a result of the study, the effect of visceral osteopathic manual therapy fascial release on bladder control, quality of life and flexibility will be evaluated.
- Detailed Description
Urinary incontinence (UI) is an important health problem that occurs when continence cannot be achieved and negatively affects the lives of individuals according to the International Continence Society (ICS). Stress urinary incontinence (SUI), one of the most common types of UI, is a problem that occurs during coughing, laughing, sneezing, exercise (one of which is caused by increased intra-abdominal pressure (Valsalva maneuver) and shows a steady increase in women with age. The aim in the treatment of SUI is to ensure that patients regain their continence skills. In recent years, conservative treatment methods have been preferred more in the treatment of SUI due to their ease of application and low cost. It is thought that Osteopathic Manual Therapy (OMT) reduces the negative effects of musculoskeletal pain and dysfunction on body systems, improves respiratory mechanics, venous and lymphatic drainage, and accordingly supports homeostasis and optimizes functions.
In this study, it is planned to investigate the effect of the visceral system and visceral fascia on SUI.
It is thought that the fascia surrounding the internal organs can be loosened and systematic diseases can be affected with the visceral osteopathic manual therapy (VOMT) method, which is among the osteopathic manual therapy methods.
Within the scope of the study, 40 volunteer female patients diagnosed with SUI will be evaluated and randomly divided into 2 groups. Day 1 evaluation scales will be applied to both groups, VOMT methods will be applied to the experimental group a total of four times a week, and bladder mobilization will be given as a home program, and no application will be made to the control group. Both groups will be re-evaluated in months 1 and 4. The inadequacy of studies conducted on this subject was an important factor in choosing this method.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 40
- Being a woman between the ages of 18 and 70
- Being able to communicate in Turkish
- Being able to read and write
- Being able to understand and follow verbal prompts
- Being willing to participate in the study
- Pregnancy
- Presence of prolapse
- Presence of vaginal and urinary system infection or malignancy
- Presence of neurological damage
- Having had any disease that may cause incontinence
- Having had surgery for SUI or urogynecological reasons in the last 2 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method pad test 4 months after registration In this test, standardized by the International Incontinence Society, the patient is asked to place a clean pad in their underwear and then do some activities in order. These activities are done in the following order;
* Drink 500 ml of water,
* Walk for 30 minutes,
* Sit down and stand up 10 times in the 45th minute, cough 10 times,
* Run for 1 minute, then pick up objects from the ground without resting,
* Finally, wash your hands for 3 minutes. After the pad is placed, the pad is taken out in the 60th minute and weighed on a precision scale in grams (gr), the dry weight is subtracted from the wet weight and the difference is recorded as data.feeling of dryness (VAS) 4 months after registration The effect of UI on the woman's life and the feeling of dryness she perceived were assessed with VAS. In the VAS assessment, the woman was asked to mark the intensity of her feeling on a 10 cm line. While the left side of the line meant "it has no effect on my life" or "I feel dry", it was stated that this "intensity increases" towards the right of the line and the far right side meant "it affects my life a lot" or "I feel constantly wet". The marked point was measured with a ruler and recorded in cm.
"International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) 4 months after registration In order to ensure standardization in pre- and post-treatment evaluations in clinical studies, there is a need for standardized questionnaire forms regarding urinary incontinence. These forms should be short, understandable and purposeful. Among the questionnaire forms regarding urinary incontinence, the "International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is thought to meet all these requirements in this regard.
Incontinence Quality of Life Questionnaire (I-QOL): 4 months after registration According to this survey, individuals are asked 28 questions about their daily lives and psychosocial situations. Individuals are asked to answer each question as no (0), mild (1), moderate (2) and severe (3). The score obtained from the twenty-eight questions is recorded as a total score. A high score means that the quality of life is negatively affected.
- Secondary Outcome Measures
Name Time Method Incontinence severity level 4 months after registration In order to determine the severity of incontinence, the incontinence severity level is determined as mild, moderate and severe according to the frequency of urine leakage (Pages I-H, Jahr S \& al.lari, 2001);
* Mild incontinence (grade 1): Incontinence that occurs involuntarily during laughing, coughing, sneezing or heavy exercise
* Moderate incontinence (grade 2): Incontinence that occurs involuntarily during light activities, walking or carrying objects
* Severe incontinence (grade 3): Incontinence that occurs even when standing up but not at restFlexibility tests(trunk extension flexibility) 4 months after registration In individuals experiencing incontinence, the flexibility of the abdominal region, back region and lower extremity should be evaluated. To evaluate trunk flexibility, trunk extension flexibility, trunk lateral flexion flexibility tests, and the Sit and Reach Test can be used to evaluate lower extremity and trunk flexibility.
Body temperature 4 months after registration Body temperature should be measured with an infrared thermometer 5 cm above and below the umbilicus and the values should be recorded.
Flexibility tests( trunk lateral flexion flexibility) 4 months after registration In individuals experiencing incontinence, the flexibility of the abdominal region, back region and lower extremity should be evaluated. To evaluate trunk flexibility, trunk extension flexibility, trunk lateral flexion flexibility tests, and the Sit and Reach Test can be used to evaluate lower extremity and trunk flexibility.
Flexibility tests( Sit and Reach Tes) 4 months after registration In individuals experiencing incontinence, the flexibility of the abdominal region, back region and lower extremity should be evaluated. To evaluate trunk flexibility, trunk extension flexibility, trunk lateral flexion flexibility tests, and the Sit and Reach Test can be used to evaluate lower extremity and trunk flexibility.
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Trial Locations
- Locations (1)
Istanbul Rumeli University
🇹🇷Istanbul, Turkey