Visceral Osteopathic Manual Therapy Methods in Women With Stress Urinary Incontinence

The Effect of 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteopathic Manipulative Treatment (OMT)
• Intervention / Treatment: Other: visceral osteopathic manual therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: NEZAHAT AKIN, PHSİOTHERAPİST; Phone Number: +905056896823; Email: nezle43@gmail.com
• Study Contact Backup: Name: ALİ CIMBIZ, PROFESSOR; Phone Number: +905353938164; Email: ali.cimbiz@rumeli.edu.tr

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Rumeli University
    • Contact: nezahat akın, physiotherapist; Phone Number: +905056896823; Email: nezle43@gmail.com
    • Principal Investigator: NEZAHAT AKIN, PHYSİOTHERAPİST

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 months after registration
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.	4 months after registration
Body temperature	Body temperature should be measured with an infrared thermometer 5 cm above and below the umbilicus and the values should be recorded.	4 months after registration
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.	4 months after registration
Flexibility tests( Sit and Reach Tes)	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.	4 months after registration

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 months after registration

Collaborators and Investigators

• Sponsor: Istanbul Rumeli University
• Investigators: Study Director: ALİ CIMBIZ, PROFESSOR, Istanbul Rumeli University

Study record dates

Study Major Dates

• Study Start (Estimated): March 10, 2025
• Primary Completion (Estimated): March 10, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Quality of Life; Urinary Stress Incontinence; Osteopathic Manipulative Treatment (OMT)
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: IRU-FTR-NA-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No