Clinical trial NCT06874543: Visceral Osteopathic Manual Therapy Methods in Women With Stress Urinary Incontinence
Official title: The Effect of Visceral Osteopathic Manual Therapy Methods in Women With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteopathic Manipulative Treatment (OMT)
Keywords: Urinary Stress Incontinence
Osteopathic Manipulative Treatment (OMT)
Quality of Life
Lead sponsor: Istanbul Rumeli University
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: pad test
timeFrame: 4 months after registration
measure: feeling of dryness (VAS)
timeFrame: 4 months after registration
measure: "International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
timeFrame: 4 months after registration
measure: Incontinence Quality of Life Questionnaire (I-QOL):
timeFrame: 4 months after registration
Secondary outcomes:
measure: Incontinence severity level
timeFrame: 4 months after registration
measure: Flexibility tests(trunk extension flexibility)
timeFrame: 4 months after registration
measure: Body temperature
timeFrame: 4 months after registration
measure: Flexibility tests( trunk lateral flexion flexibility)
timeFrame: 4 months after registration
measure: Flexibility tests( Sit and Reach Tes)
timeFrame: 4 months after registration
Other outcomes:
measure: Demographic data form
timeFrame: 4 months after registration
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Rumeli University
Study officials:
affiliation: Istanbul Rumeli University
name: ALİ CIMBIZ, PROFESSOR
role: STUDY_DIRECTOR
References: