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NCT Number: NCT06874543

Visceral Osteopathic Manual Therapy Methods in Women With Stress Urinary Incontinence

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Rumeli University

Istanbul, Turkey (Türkiye)

Location contact

NEZAHAT AKIN, PHYSİOTHERAPİST

PRINCIPAL_INVESTIGATOR

nezahat akın, physiotherapist

CONTACT

[email protected]

+905056896823

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

visceral osteopathic manual therapy

Other

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

Primary outcomes

  1. pad test

    Time frame: 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.
  2. feeling of dryness (VAS)

    Time frame: 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.

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

    Time frame: 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.

  4. Incontinence Quality of Life Questionnaire (I-QOL):

    Time frame: 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 outcomes

  1. Incontinence severity level

    Time frame: 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 rest
  2. Flexibility tests(trunk extension flexibility)

    Time frame: 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.

  3. Body temperature

    Time frame: 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.

  4. Flexibility tests( trunk lateral flexion flexibility)

    Time frame: 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.

  5. Flexibility tests( Sit and Reach Tes)

    Time frame: 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.

Other outcomes

  1. Demographic data form

    Time frame: 4 months after registration

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

ALİ CIMBIZ, PROFESSOR

CONTACT

[email protected]

+905353938164

NEZAHAT AKIN, PHSİOTHERAPİST

CONTACT

[email protected]

+905056896823

Sponsors and collaborators

Lead sponsor

Istanbul Rumeli University

Other

Registry information

Official study title

The Effect of Visceral Osteopathic Manual Therapy Methods in Women With Stress Urinary Incontinence

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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