Visceral Osteopathic Manual Therapy Methods in Women With Stress Urinary Incontinence

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorIstanbul Rumeli University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Presence of prolapse

Presence of vaginal and urinary system infection or malignancy

Presence of neurological damage

Trial design

Design model

Parallel

Treatments tested in this trial

  • visceral osteopathic manual therapy

    Other intervention

    In the study, relaxation techniques, hepato-gastric ligamentum mobilization, pyloric valve mobilization, sphincter odi mobilization, sphincter ilio-jejunum mobilization, cecal valve mobilization, iliopsoas and iliacus mobilization, peritoneal mobilization, intestine, kidney, bladder, stomach, liver and bladder organ mobilizations will be applied to the experimental group patients as VOMT program. Until the next session, bladder mobilization will be taught as a home program and they will be asked to do it every day. After VOMT is applied by the physiotherapist once a week, a total of 4 times, the evaluation scales will be applied again. In order to see the long-term effect, the patients will be evaluated again in the first month and the third month after the end of the treatment. The forms will be filed as pre-treatment, post-treatment, first month and third month data and will be entered into the computer and recorded

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Group 1: Study group visceral osteopathic manual therapy method will be appliedActive comparator 1 intervention
Group B: Group 2: Evaluation scales will be applied to control group patients on the first day, and the scaleNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

pad test

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.

Time frame
4 months after registration
2

feeling of dryness (VAS)

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.

Time frame
4 months after registration
3

"International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)

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.

Time frame
4 months after registration
4

Incontinence Quality of Life Questionnaire (I-QOL):

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.

Time frame
4 months after registration

Secondary outcomes

1

Incontinence severity level

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 rest

Time frame
4 months after registration
2

Flexibility tests(trunk extension flexibility)

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.

Time frame
4 months after registration
3

Body temperature

Body temperature should be measured with an infrared thermometer 5 cm above and below the umbilicus and the values should be recorded.

Time frame
4 months after registration
4

Flexibility tests( trunk lateral flexion flexibility)

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.

Time frame
4 months after registration

Other outcomes

1

Demographic data form

A detailed history and a complete physical examination are the first and most important steps used in the evaluation of the patient. Personal information such as age, weight, occupation, and educational status should be questioned with the demographic data form, where information about the person can be questioned. The signs and symptoms of UI, and the presence of urinary incontinence that occurs after an increase in intra-abdominal pressure such as coughing, sneezing, or laughing should be questioned.

Time frame
4 months after registration

Sponsors and contacts

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