Visceral Osteopathic Manual Therapy Methods in Women With Stress Urinary Incontinence

NCT ID: NCT06874543

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-10

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Osteopathic Manipulative Treatment (OMT)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

40 volunteer female patients who applied to the polyclinics with complaints of urinary incontinence, diagnosed with SUI by specialist doctors, aged between 18 and 70, who can communicate in Turkish, who can read and write, and who can accept verbal warnings will be included. Patients with prolapse, vaginal and urinary system infection or malignancy, neurological damage, or who have had a disease or surgery that may cause incontinence, and pregnant women will be excluded from the study. Patients will be randomly divided into 2 groups as treatment and control, with 20 people in each group.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1: Study group visceral osteopathic manual therapy method will be applied

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.

Group Type ACTIVE_COMPARATOR

visceral osteopathic manual therapy

Intervention Type 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

Group 2: Evaluation scales will be applied to control group patients on the first day, and the scale

They were evaluated on the first application day and followed up ten times in parallel with the study group, at 1 month, 2 months and 4 months, a total of 4 times.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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visceral osteopathic manual therapy

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Rumeli University

OTHER

Sponsor Role lead

Responsible Party

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NEZAHAT AKIN

Principal investıgator physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ALİ CIMBIZ, PROFESSOR

Role: STUDY_DIRECTOR

Istanbul Rumeli University

Locations

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Istanbul Rumeli University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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NEZAHAT AKIN, PHSİOTHERAPİST

Role: CONTACT

+905056896823

ALİ CIMBIZ, PROFESSOR

Role: CONTACT

+905353938164

Facility Contacts

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nezahat akın, physiotherapist

Role: primary

+905056896823

Other Identifiers

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IRU-FTR-NA-01

Identifier Type: -

Identifier Source: org_study_id

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