Osteopathic Manipulative Treatment (OMT)NCT06874543
Visceral Osteopathic Manual Therapy Methods in Women With Stress Urinary Incontinence
A study testing visceral osteopathic manual therapy in people with Osteopathic Manipulative Treatment (OMT), run by Istanbul Rumeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Osteopathic Manipulative Treatment (OMT)
- What is being tested?
- visceral osteopathic manual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul Rumeli University
Istanbul
nezahat akın, physiotherapist, +905056896823, nezle43@gmail.com
NEZAHAT AKIN, PHYSİOTHERAPİST
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteopathic Manipulative Treatment (OMT)
- Being tested
- visceral osteopathic manual therapy
- Keywords
- Urinary Stress Incontinence, Osteopathic Manipulative Treatment (OMT), Quality of Life
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visceral osteopathic manual therapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 months after registration
Secondary outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 months after registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start10 Mar 2025 (estimated)
- Primary completion10 Mar 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteopathic Manipulative Treatment (OMT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Rumeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NEZAHAT AKIN, Istanbul Rumeli University
- Investigators
- ALİ CIMBIZ, PROFESSOR, Study director, Istanbul Rumeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874543
- Sponsor's protocol ID
- IRU-FTR-NA-01
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Visceral Osteopathic Manual Therapy Methods in Women With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06874543
- Acronym / sponsor ID
- IRU-FTR-NA-01
- Conditions
- Osteopathic Manipulative Treatment (OMT)
- Keywords
- Urinary Stress Incontinence, Osteopathic Manipulative Treatment (OMT), Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul Rumeli UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (estimated)
- Primary completion
- 10 Mar 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Study group visceral osteopathic manual therapy method will be applied | Active comparator | Other: visceral osteopathic manual therapyIn 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 | 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| visceral osteopathic manual therapyIn 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 | Group 1: Study group visceral osteopathic manual therapy method will be applied |
Primary outcome
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.
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.
"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.
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.
5 secondary outcomes
Incontinence severity level
Time frame: 4 months after registration
Flexibility tests(trunk extension flexibility)
Time frame: 4 months after registration
Body temperature
Time frame: 4 months after registration
Flexibility tests( trunk lateral flexion flexibility)
Time frame: 4 months after registration
Flexibility tests( Sit and Reach Tes)
Time frame: 4 months after registration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ALİ CIMBIZ, PROFESSOR study director
Istanbul Rumeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing visceral osteopathic manual therapy in people with Osteopathic Manipulative Treatment (OMT), run by Istanbul Rumeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NEZAHAT AKIN, PHSİOTHERAPİST (+905056896823, nezle43@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pad test (time frame: 4 months after registration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.