Visceral Osteopathic Manual Therapy Methods in Women With Stress Urinary Incontinence

NCT06874543 | Not Yet Recruiting DMC

• 1 other identifier: IRU-FTR-NA-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteopathic Manipulative Treatment (OMT)

Keywords

Urinary Stress Incontinence; Osteopathic Manipulative Treatment (OMT); Quality of Life

Outcome Measures

Primary Outcomes (4)

• 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.

  4 months after registration

• 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.

  4 months after registration

• "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.

  4 months after registration

• 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.

  4 months after registration

Secondary Outcomes (5)

• Incontinence severity level

  4 months after registration

• Flexibility tests(trunk extension flexibility)

  4 months after registration

• Body temperature

  4 months after registration

• Flexibility tests( trunk lateral flexion flexibility)

  4 months after registration

• Flexibility tests( Sit and Reach Tes)

  4 months after registration

Other Outcomes (1)

• Demographic data form

  4 months after registration

Study Arms (2)

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

ACTIVE COMPARATOR

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.

Other: visceral osteopathic manual therapy

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

NO INTERVENTION

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.

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: • Being a woman between the ages of 18 and 70
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Rumeli University: lead

Study Sites (1)

Istanbul Rumeli University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• ALİ CIMBIZ, PROFESSOR

  Istanbul Rumeli University

  STUDY DIRECTOR

Central Study Contacts

NEZAHAT AKIN, PHSİOTHERAPİST

CONTACT

+905056896823; nezle43@gmail.com

ALİ CIMBIZ, PROFESSOR

CONTACT

+905353938164; ali.cimbiz@rumeli.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investıgator physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 13, 2025
• Study Start: March 10, 2025
• Primary Completion: March 10, 2025
• Study Completion: June 30, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)