Urinary Incontinence (UI)NCT06988683
Posture, Core Stabilization, Respiratory Muscle Strength and Quality of Life in Women With Urinary Incontinence
An observational study of Urinary Incontinence (UI), run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
When the literature was examined, it was observed that there were studies on parameters such as quality of life, pelvic floor muscle strength in women with urinary incontinence, but there were not enough studies on posture, respiratory function, constipation and cough strength. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence (UI)
- Type of treatment
- Injection or infusion
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2024to 24 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study, in which we aimed to evaluate individuals diagnosed with urinary incontinence, was conducted in the Gynaecology and Obstetrics outpatient clinic of Buca Seyfi Demirsoy Training and Research Hospital. Individuals diagnosed with UI by an Obstetrics and Gynaecology Specialist were included in the study. Thirty-two volunteer individuals diagnosed with UI who met the inclusion criteria and 30 individuals without urinary incontinence were included in the study.
Who may be able to join
- Inclusion Criteria for Women with Urinary Incontinence
- Being diagnosed with urinary incontinence
- Volunteer to participate in the study
- To be over 18 years of age
- To be able to communicate verbally and in written Turkish
- Inclusion Criteria for Women without Urinary Incontinence
Show all 10Show fewer
- No symptoms of urinary incontinence
- Volunteer to participate in the study
- To be over 18 years of age
- Establish written and verbal communication in Turkish
Who cannot join
- The presence of any pathology that may affect pelvic floor function
- Trauma to the lumbopelvic, abdominal, thoracic or lower extremities within the last six months
- Urinary tract infection
- Grade III or higher urogenital prolapse
- Neurological or psychiatric illness
- Being pregnant
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Democracy University
Izmir, Karabağlar/İzmir, 35140
About this study
Official title: Investigation of Posture, Core Stabilization, Respiratory Muscle Strength and Function, and Quality of Life in Women With Urinary Incontinence
When the literature was examined, it was observed that there were studies on parameters such as quality of life, pelvic floor muscle strength in women with urinary incontinence, but there were not enough studies on posture, respiratory function, constipation and cough strength. Therefore, in this study, the researchers aimed to investigate posture, constipation, core muscle stabilisation, respiratory muscle strength and function, cough strength and quality of life of women with urinary incontinence and to compare these parameters with women without urinary incontinence.
Read the detailed description
Urinary incontinence (UI) is involuntary urinary leakage and may lead to social and economic problems. There are different types of UI such as stress type, urge, mixed type. Risk factors include age, gender, genetics, menopause, obesity, labour and surgical history. Posture is the position of the body during movement or posture and can also be defined as muscle balance. Studies have reported that there may be a relationship between UI and respiratory problems and postural motor control disorder. Various methods are used in posture assessment, but there is no study evaluating posture with artificial intelligence in women with UI in the literature.Constipation is a particularly serious risk for the development of stress urinary incontinence (SUI). Severe constipation in women leads to differences in the neural function of the pelvic floor by reducing the neural effect of the external anal sphincter and pelvic floor muscles (PFM). Many conditions that increase intra-abdominal pressure (IAB) cause the onset or development of UI. Constipation also leads to an increase in intra-abdominal pressure and thus an increase in intra-bladder pressure. Recently, researchers have investigated the relationship between constipation and urinary incontinence, but the results have been inconsistent. Core stabilisation is the ability to regulate the posture and movement of the body over the pelvis. During forced exhalation activities (Valsalva, coughing, laughing, etc.), the pelvic floor muscles (PFM), abdominal muscles and diaphragm work together to increase intra-abdominal pressure and prevent incontinence. The trunk stabilisation muscles work in concert to keep the abdomen and lumbopelvic region stable by regulating intra-abdominal pressure during various activities of daily living. The activity of these muscles alters intra-abdominal pressure, which in turn can affect the activity of the pelvic floor muscles. Cough is associated with urinary incontinence in women by affecting the concerted contraction of thoracic, abdominal and pelvic muscles. Women with chronic cough are 55-63.3% more likely to develop severe UI than women without chronic cough. Chronic cough has been shown to be one of the common risk factors for UI, along with advanced age, high BMI, history of vaginal delivery and surgical interventions. Urinary incontinence is a public health problem that seriously affects women's quality of life and social participation, as well as being common among older women. UI has a negative impact on individuals' sleep, sexual function, work performance and psychosocial aspects. As symptoms increase, quality of life decreases, but women usually realise the effects of UI years later by seeking professional help. When the literature was reviewed, it was observed that there were studies on parameters such as quality of life and pelvic floor muscle strength in women with urinary incontinence, but there were not enough studies on posture, respiratory functions, constipation and coughing strength. Therefore, in this study, the researchers aimed to investigate posture, constipation, core muscle stabilisation, respiratory muscle strength and function, cough strength and quality of life of women with urinary incontinence and to compare these parameters with women without urinary incontinence.
- Conditions
- Urinary Incontinence (UI)
- Keywords
- Core stabilization, cough force, posture, respiratory muscle strength, urinary incontinence, maximal expiratory pressure
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Group (Urinary incontinance) | The study included 32 volunteer individuals who were diagnosed with urinary Incontinance and fulfilled the inclusion criteria. Pad test was applied to evaluate the degree of urinary incontinence of the patients. Posture analyses of the individuals were evaluated with Fizyosoft Becure Mobile Posture Application. Stabiliser Pressure Biofeedback Unit® (BBU) (Chattanooga Medical Suplly Inc, Chattanooga, TN) was used for core muscle stabilisation, Cosmed® Pony FX was used for respiratory muscle strength and functions and ExpiRite Peak Flow Meter (ExpiRite Peak Flow Meter, China) was used for cough strength assessment. Modified Constipation Rating Scale (MCAS), Rome IV Criteria, Bristol Stool Scale (BGS) were used to evaluate constipation, while quality of life and pelvic floor symptoms were evaluated using Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7) and Global Pelvic Floor Discomfort Questionnaire (GPTRA). | |
| Control Group | The study included 30 asymptomatic volunteers without urinary incontinence without a diagnosis of UI. In this study, demographic information form was used to evaluate the socio-demographic status. Posture analyses of the individuals were evaluated with Fizyosoft Becure Mobile Posture Application. Stabiliser Pressure Biofeedback Unit® (BBU) (Chattanooga Medical Suplly Inc, Chattanooga, TN) was used for core muscle stabilisation, Cosmed® Pony FX was used for respiratory muscle strength and functions and ExpiRite Peak Flow Meter (ExpiRite Peak Flow Meter, China) was used for cough strength assessment. Modified Constipation Rating Scale (MCAS), Rome IV Criteria, Bristol Stool Scale (BGS) were used to evaluate constipation, while quality of life and pelvic floor symptoms were evaluated using Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7) and Global Pelvic Floor Discomfort Questionnaire (GPTRA). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal inspiratory pressure (MIP)
The MIP which shows respiratory muscle strength will be evaluated using a portable mouth pressure measuring device based on American Thoracic Society and European Respiratory Society criteria.
Measured: 1 year
Maximal expiratory pressure (MEP)
The MEP which shows respiratory muscle strength will be evaluated using a portabl mouth pressure measuring device based on American Thoracic Society and European Respiratory Society criteria.
Measured: 1 year
Secondary outcomes (13)
Forced vital capacity (FVC)
Pulmonary function (Forced vital capacity (FVC)) will be evaluated with a spirometer. In the study, measurements will be made using the Cosmed Omnia microQuark 1.5 (Cosmed, Rome, Italy) device. Considering that dizziness may occur during forced expiration, measurements will be made while individuals are in a sitting position. While participants are sitting in a comfortable position in a chair with a backrest, nose clip will be attached and they will be asked to bite the mouthpieces with their teeth and close their lips in a way that does not allow air to escape. The tests will be performed at least 3 times by the participants and care will be taken to ensure that the expiration time is at least 6 seconds and the plateau time is 1 second. Due to the device software that records all three data, it saves the average of the two best data and processes it as a value.
Measured: 1 year
Forced expiratory volume in the first second (FEV1)
Pulmonary function (Forced expiratory volume in the rst second (FEV1)) will be evaluated with a spirometer.
Measured: 1 year
FEV1/FVC
Pulmonary function (FEV1/FVC) will be evaluated with a spirometer.
Measured: 1 year
Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%)) will be evaluated with a spirometer.
Measured: 1 year
Peak flow rate (PEF)
Pulmonary function (Peak ow rate (PEF)) will be evaluated with a spirometer.
Measured: 1 year
Posture Assessment
Posture assessment will be performed using an artificial intelligence based posture analysis package developed by Fizyosoft and Becure.
Measured: 1 year
Core Stabilization Assessment
Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) will be used for core stabilization assessment. The five-level core stabilization test developed by Sahrmann will be used to assess the participants' core stabilization levels.
Measured: 1 year
Cough Force Assessment
Cough force will be measured using a portable peak flow meter (PEF meter) (ExpiRite Peak Flow Meter, China). During the test, participants cough vigorously into the device following a deep inspiration in an upright position. The peak flow rate (PEF) reached is recorded and a disposable mouthpiece is used for each participant. Three measurements are taken and the highest value is taken for analysis, with a 30 second rest period between measurements.
Measured: 1 year
Modified Constipation Assessment Scale
This scale was developed by McMillan et al. in 1989 to determine the status and severity of constipation. It is a valid and reliable questionnaire consisting of nine questions and can be used in children and adults. Respondents rate each question as "no problem" (0), "some problem" (1) or "severe problem" (2). The total score ranges from zero (no constipation) to 18 (most severe constipation).
Measured: 1 year
Rome IV Criteria
It is a clinical guideline defining the presence of constipation. The Rome IV criteria have been modified with regard to the frequency of abdominal pain, emphasizing the need for more frequent episodes of abdominal pain for diagnosis. At least two of these symptoms must occur at least once a week for a month, without any other underlying medical condition.
Measured: 1 year
Bristol Stool Scale
Developed in 1990 by Lewis and Heaton at the University of Bristol, the Bristol Stool Scale (BGS) is a scale that assesses the physical properties and intestinal transit time of stool. Stool is divided into seven types: Types 3, 4 and 5 indicate normal stools; Types 1 and 2 indicate constipation; and Types 6 and 7 indicate diarrhea. Low scores indicate slow and high scores indicate fast intestinal transit.
Measured: 1 year
Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7)
UDI-6 and IIQ-7 are short forms that assess the quality of life in urinary incontinence. The UIQ-6 consists of 6 questions including symptoms of urge, stress and emptying and the score is between 0-18. The IIQ-7 consists of 7 questions assessing physical activity, travel, social relationships and emotional health, with a score between 0-21. Higher scores indicate a reduced quality of life.
Measured: 1 year
Global Pelvic Floor Bother Questionnaire
This questionnaire is a scale that assesses women's pelvic floor symptoms and severity. It covers symptoms such as urinary incontinence, pelvic organ prolapse and fecal incontinence. It consists of nine questions; respondents answer "yes/no" and rate severity from 1-5. The total score is 0-100, with a higher score indicating more symptoms.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start5 Jan 2024
- Primary completion30 May 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence (UI)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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Çınar Özdemir, Izmir Democracy University
- Investigators
- Özlem Çinar Özdemir, Prof.Dr, Principal investigator, İzmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988683
- Sponsor's protocol ID
- urinary incontinence
- Status last verified
- May 2025
- First submitted
- 15 Jan 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Talasz H, Kofler M, Kalchschmid E, Pretterklieber M, Lechleitner M. Breathing with the pelvic floor? Correlation of pelvic floor muscle function and expiratory flows in healthy young nulliparous women. Int Urogynecol J. 2010 Apr;21(4):475-81. doi: 10.1007/s00192-009-1060-1. Epub 2009 Dec 8.
PubMed 19997721Stein TA, DeLancey JO. Structure of the perineal membrane in females: gross and microscopic anatomy. Obstet Gynecol. 2008 Mar;111(3):686-93. doi: 10.1097/AOG.0b013e318163a9a5.
PubMed 18310372Steenstrup B, Pelleray M, Cornu JN, Verdun S, Gilliaux M. Neutral posture education during cough can reduce urine leakage in women with cough-related stress urinary incontinence. Prog Urol. 2023 Dec;33(17):1083-1091. doi: 10.1016/j.purol.2023.09.002. Epub 2023 Sep 26.
PubMed 37758607Shi ZH, Jonkman A, de Vries H, Jansen D, Ottenheijm C, Girbes A, Spoelstra-de Man A, Zhou JX, Brochard L, Heunks L. Expiratory muscle dysfunction in critically ill patients: towards improved understanding. Intensive Care Med. 2019 Aug;45(8):1061-1071. doi: 10.1007/s00134-019-05664-4. Epub 2019 Jun 24.
PubMed 31236639Ptaszkowski K, Paprocka-Borowicz M, Slupska L, Bartnicki J, Dymarek R, Rosinczuk J, Heimrath J, Dembowski J, Zdrojowy R. Assessment of bioelectrical activity of synergistic muscles during pelvic floor muscles activation in postmenopausal women with and without stress urinary incontinence: a preliminary observational study. Clin Interv Aging. 2015 Sep 23;10:1521-8. doi: 10.2147/CIA.S89852. eCollection 2015.
PubMed 26445533
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Posture, Core Stabilization, Respiratory Muscle Strength and Function, and Quality of Life in Women With Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06988683
- Acronym / sponsor ID
- urinary incontinence
- Conditions
- Urinary Incontinence (UI)
- Keywords
- Core stabilization, cough force, posture, respiratory muscle strength, urinary incontinence, maximal expiratory pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 25 May 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.
When the literature was examined, it was observed that there were studies on parameters such as quality of life, pelvic floor muscle strength in women with urinary incontinence, but there were not enough studies on posture, respiratory function, constipation and cough strength. Therefore, in this study, the researchers aimed to investigate posture, constipation, core muscle stabilisation, respiratory muscle strength and function, cough strength and quality of life of women with urinary incontinence and to compare these parameters with women without urinary incontinence.
Detailed description
Urinary incontinence (UI) is involuntary urinary leakage and may lead to social and economic problems. There are different types of UI such as stress type, urge, mixed type. Risk factors include age, gender, genetics, menopause, obesity, labour and surgical history. Posture is the position of the body during movement or posture and can also be defined as muscle balance. Studies have reported that there may be a relationship between UI and respiratory problems and postural motor control disorder. Various methods are used in posture assessment, but there is no study evaluating posture with artificial intelligence in women with UI in the literature.Constipation is a particularly serious risk for the development of stress urinary incontinence (SUI). Severe constipation in women leads to differences in the neural function of the pelvic floor by reducing the neural effect of the external anal sphincter and pelvic floor muscles (PFM). Many conditions that increase intra-abdominal pressure (IAB) cause the onset or development of UI. Constipation also leads to an increase in intra-abdominal pressure and thus an increase in intra-bladder pressure. Recently, researchers have investigated the relationship between constipation and urinary incontinence, but the results have been inconsistent. Core stabilisation is the ability to regulate the posture and movement of the body over the pelvis. During forced exhalation activities (Valsalva, coughing, laughing, etc.), the pelvic floor muscles (PFM), abdominal muscles and diaphragm work together to increase intra-abdominal pressure and prevent incontinence. The trunk stabilisation muscles work in concert to keep the abdomen and lumbopelvic region stable by regulating intra-abdominal pressure during various activities of daily living. The activity of these muscles alters intra-abdominal pressure, which in turn can affect the activity of the pelvic floor muscles. Cough is associated with urinary incontinence in women by affecting the concerted contraction of thoracic, abdominal and pelvic muscles. Women with chronic cough are 55-63.3% more likely to develop severe UI than women without chronic cough. Chronic cough has been shown to be one of the common risk factors for UI, along with advanced age, high BMI, history of vaginal delivery and surgical interventions. Urinary incontinence is a public health problem that seriously affects women's quality of life and social participation, as well as being common among older women. UI has a negative impact on individuals' sleep, sexual function, work performance and psychosocial aspects. As symptoms increase, quality of life decreases, but women usually realise the effects of UI years later by seeking professional help. When the literature was reviewed, it was observed that there were studies on parameters such as quality of life and pelvic floor muscle strength in women with urinary incontinence, but there were not enough studies on posture, respiratory functions, constipation and coughing strength. Therefore, in this study, the researchers aimed to investigate posture, constipation, core muscle stabilisation, respiratory muscle strength and function, cough strength and quality of life of women with urinary incontinence and to compare these parameters with women without urinary incontinence.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group (Urinary incontinance) | – | –The study included 32 volunteer individuals who were diagnosed with urinary Incontinance and fulfilled the inclusion criteria. Pad test was applied to evaluate the degree of urinary incontinence of the patients. Posture analyses of the individuals were evaluated with Fizyosoft Becure Mobile Posture Application. Stabiliser Pressure Biofeedback Unit® (BBU) (Chattanooga Medical Suplly Inc, Chattanooga, TN) was used for core muscle stabilisation, Cosmed® Pony FX was used for respiratory muscle strength and functions and ExpiRite Peak Flow Meter (ExpiRite Peak Flow Meter, China) was used for cough strength assessment. Modified Constipation Rating Scale (MCAS), Rome IV Criteria, Bristol Stool Scale (BGS) were used to evaluate constipation, while quality of life and pelvic floor symptoms were evaluated using Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7) and Global Pelvic Floor Discomfort Questionnaire (GPTRA). |
| Control Group | – | –The study included 30 asymptomatic volunteers without urinary incontinence without a diagnosis of UI. In this study, demographic information form was used to evaluate the socio-demographic status. Posture analyses of the individuals were evaluated with Fizyosoft Becure Mobile Posture Application. Stabiliser Pressure Biofeedback Unit® (BBU) (Chattanooga Medical Suplly Inc, Chattanooga, TN) was used for core muscle stabilisation, Cosmed® Pony FX was used for respiratory muscle strength and functions and ExpiRite Peak Flow Meter (ExpiRite Peak Flow Meter, China) was used for cough strength assessment. Modified Constipation Rating Scale (MCAS), Rome IV Criteria, Bristol Stool Scale (BGS) were used to evaluate constipation, while quality of life and pelvic floor symptoms were evaluated using Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7) and Global Pelvic Floor Discomfort Questionnaire (GPTRA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study, in which we aimed to evaluate individuals diagnosed with urinary incontinence, was conducted in the Gynaecology and Obstetrics outpatient clinic of Buca Seyfi Demirsoy Training and Research Hospital. Individuals diagnosed with UI by an Obstetrics and Gynaecology Specialist were included in the study. Thirty-two volunteer individuals diagnosed with UI who met the inclusion criteria and 30 individuals without urinary incontinence were included in the study.
Key inclusion criteria (10 listed)
- Inclusion Criteria for Women with Urinary Incontinence
- Inclusion Criteria for Women without Urinary Incontinence
Key exclusion criteria (6 listed)
- The presence of any pathology that may affect pelvic floor function
- Trauma to the lumbopelvic, abdominal, thoracic or lower extremities within the last six months
- Urinary tract infection
- Grade III or higher urogenital prolapse
- Neurological or psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximal inspiratory pressure (MIP)
Time frame: 1 year
The MIP which shows respiratory muscle strength will be evaluated using a portable mouth pressure measuring device based on American Thoracic Society and European Respiratory Society criteria.
Maximal expiratory pressure (MEP)
Time frame: 1 year
The MEP which shows respiratory muscle strength will be evaluated using a portabl mouth pressure measuring device based on American Thoracic Society and European Respiratory Society criteria.
13 secondary outcomes
Forced vital capacity (FVC)
Time frame: 1 year
Forced expiratory volume in the first second (FEV1)
Time frame: 1 year
FEV1/FVC
Time frame: 1 year
Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
Time frame: 1 year
Peak flow rate (PEF)
Time frame: 1 year
Posture Assessment
Time frame: 1 year
Core Stabilization Assessment
Time frame: 1 year
Cough Force Assessment
Time frame: 1 year
Modified Constipation Assessment Scale
Time frame: 1 year
Rome IV Criteria
Time frame: 1 year
Bristol Stool Scale
Time frame: 1 year
Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7)
Time frame: 1 year
Global Pelvic Floor Bother Questionnaire
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Results publication: PubMed 19997721Talasz H, Kofler M, Kalchschmid E, Pretterklieber M, Lechleitner M. Breathing with the pelvic floor? Correlation of pelvic floor muscle function and expiratory flows in healthy young nulliparous women. Int Urogynecol J. 2010 Apr;21(4):475-81. doi: 10.1007/s00192-009-1060-1. Epub 2009 Dec 8.
- Results publication: PubMed 18310372Stein TA, DeLancey JO. Structure of the perineal membrane in females: gross and microscopic anatomy. Obstet Gynecol. 2008 Mar;111(3):686-93. doi: 10.1097/AOG.0b013e318163a9a5.
- Results publication: PubMed 37758607Steenstrup B, Pelleray M, Cornu JN, Verdun S, Gilliaux M. Neutral posture education during cough can reduce urine leakage in women with cough-related stress urinary incontinence. Prog Urol. 2023 Dec;33(17):1083-1091. doi: 10.1016/j.purol.2023.09.002. Epub 2023 Sep 26.
- Results publication: PubMed 31236639Shi ZH, Jonkman A, de Vries H, Jansen D, Ottenheijm C, Girbes A, Spoelstra-de Man A, Zhou JX, Brochard L, Heunks L. Expiratory muscle dysfunction in critically ill patients: towards improved understanding. Intensive Care Med. 2019 Aug;45(8):1061-1071. doi: 10.1007/s00134-019-05664-4. Epub 2019 Jun 24.
- Results publication: PubMed 26445533Ptaszkowski K, Paprocka-Borowicz M, Slupska L, Bartnicki J, Dymarek R, Rosinczuk J, Heimrath J, Dembowski J, Zdrojowy R. Assessment of bioelectrical activity of synergistic muscles during pelvic floor muscles activation in postmenopausal women with and without stress urinary incontinence: a preliminary observational study. Clin Interv Aging. 2015 Sep 23;10:1521-8. doi: 10.2147/CIA.S89852. eCollection 2015.
- 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. This study is not recruiting at the moment.
Özlem Çinar Özdemir, Prof.Dr principal investigator
İzmir Democracy University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence (UI), run by Izmir Democracy 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 10 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: finished, as of the sponsor's last update on 25 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal inspiratory pressure (MIP) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06988683, which also lists 5 linked publications.
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 25 May 2025.